DOCSLIB.ORG

Study Protocol G1T28-02 Eudract # 2016-001583-11

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Study Protocol G1T28-02 Eudract # 2016-001583-11 Phase 1b/2a Safety and Pharmacokinetic Study of G1T28 in Patients with Extensive-Stage Small Cell Lung Cancer (SCLC) Receiving Etoposide and Carboplatin Chemotherapy Clinical Study Protocol G1T28-02 EudraCT # 2016-001583-11 Original Protocol Issue Date: 27 April 2015 Amendment 7 Issue Date: 15 September 2016 Version: 8.0 Investigational Phase: 1b/2a Sponsored by: G1 Therapeutics 79 T.W. Alexander Drive 4501 Research Commons, Suite 100 Research Triangle Park, NC 27709 919-213-9835 THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR REGISTRATION OF PRODUCTS FOR G1 THERAPEUTICS. THIS DOCUMENT SHOULD NOT BE DISCLOSED OR USED, IN WHOLE OR IN PART, FOR ANY OTHER PURPOSE WITHOUT THE PRIOR WRITTEN CONSENT OF G1 THERAPEUTICS. G1 Therapeutics CONFIDENTIAL G 1 Therapeutics, Inc. Clinical Study Protocol G 1T28-02 GlT28 SPONSOR SIGNATURE PAGE SPONSOR:GlTHERAPEUTICS I have read and understand the contents of this clinical protocol for Study G 1T28-02 dated 15 September 2016 and I agree to meet all obligations of the sponsor as detailed in all applicable regulations and guidelines. In addition, I will inform the principal investigator and all other investigators of all relevant information that becomes available during the conduct of this study. Approved by: f~~2o(C ~ Date ChiefRajesh Medical Officer, G 1 Therapeutics Version: 8.0, dated 15 September 2016 Page 2 of 105 G 1 Therapeutics CONFIDENTIAL G1 Therapeutics, Inc. Clinical Study Protocol G1T28-02 G1T28 PROTOCOL SIGNATURE PAGE Clinical Study Protocol G1T28-02: Phase 1b/2a Safety and Pharmacokinetic Study of G1T28 in Patients with Extensive-Stage Small Cell Lung Cancer (SCLC) Receiving Etoposide and Carboplatin Chemotherapy Original Protocol Issue Date: 27 April 2015 Version: 8.0, dated 15 September 2016 By signing below, the investigator agrees to adhere to the protocol as outlined. Principal Investigator: Principal Investigator Signature Date Principal Investigator Name Institution Version: 8.0, dated 15 September 2016 Page 3 of 105 G1 Therapeutics CONFIDENTIAL G1 Therapeutics, Inc. Clinical Study Protocol G1T28-02 G1T28 1. TABLE OF CONTENTS SPONSOR SIGNATURE PAGE ........................................................................................................................... 2 PROTOCOL SIGNATURE PAGE ........................................................................................................................ 3 1. TABLE OF CONTENTS ............................................................................................................................... 4 1.1. List of In-Text Tables ....................................................................................................................... 8 1.2. List of In-Text Figures ...................................................................................................................... 8 2. LIST OF ABBREVIATIONS ........................................................................................................................ 9 3. SYNOPSIS .................................................................................................................................................. 13 4. INTRODUCTION ....................................................................................................................................... 25 4.1. Background ..................................................................................................................................... 25 4.2. Summary of Clinical Data ............................................................................................................... 26 4.3. Summary of Nonclinical Data ......................................................................................................... 27 4.3.1. Pharmacology Studies ................................................................................................... 27 4.3.2. Pharmacokinetic Studies ............................................................................................... 28 4.3.3. Toxicity and Safety Studies........................................................................................... 29 4.3.4. Potential Risks ............................................................................................................... 29 4.4. Study and Dose Rationale ............................................................................................................... 30 4.5. Risk/Benefit Assessment ................................................................................................................. 31 5. STUDY OBJECTIVES ................................................................................................................................ 32 6. INVESTIGATIONAL PLAN ...................................................................................................................... 33 6.1. Overall Study Design and Plan ....................................................................................................... 33 6.1.1. Part 1 ............................................................................................................................. 33 6.1.1.1. Definition of Dose-Limiting Toxicities (Applicable to Cycle 1 of the Phase 1b Dose-Finding Portion of Part 1) ........................ 34 6.1.1.2. Criteria for Adjusting G1T28 Dose Based on Pharmacokinetic Parameters .................................................................... 35 6.1.1.3. G1T28 Dose Evaluation ........................................................................... 35 6.1.1.4. Safety Monitoring Committee ................................................................. 37 6.1.2. Part 2 ............................................................................................................................. 37 6.1.3. Criteria for Subsequent Cycles and Study Duration ...................................................... 38 6.1.4. Safety Assessments ....................................................................................................... 39 6.1.5. Tumor Assessment ........................................................................................................ 39 7. STUDY POPULATION .............................................................................................................................. 41 7.1. Selection of Patients ........................................................................................................................ 41 7.1.1. Inclusion Criteria ........................................................................................................... 41 7.1.2. Exclusion Criteria.......................................................................................................... 42 8. TREATMENTS ........................................................................................................................................... 44 8.1. Treatments Administered ................................................................................................................ 44 8.2. Investigational Products .................................................................................................................. 45 8.2.1. Identity .......................................................................................................................... 45 8.2.1.1. G1T28 ...................................................................................................... 45 8.2.1.2. Placebo ..................................................................................................... 45 8.2.1.3. Etoposide and Carboplatin ....................................................................... 45 8.2.2. Packaging and Labeling ................................................................................................ 45 8.2.2.1. G1T28 ...................................................................................................... 45 8.2.2.2. Placebo ..................................................................................................... 45 Version: 8.0, dated 15 September 2016 Page 4 of 105 G1 Therapeutics CONFIDENTIAL G1 Therapeutics, Inc. Clinical Study Protocol G1T28-02 G1T28 8.2.2.3. Etoposide and Carboplatin ....................................................................... 45 8.2.3. Storage .......................................................................................................................... 46 8.2.3.1. G1T28 ...................................................................................................... 46 8.2.3.2. Placebo ..................................................................................................... 46 8.2.3.3. Etoposide and Carboplatin ....................................................................... 46 8.2.4. Procedure for Dispensing .............................................................................................. 46 8.2.5. Investigational Product Accountability ......................................................................... 46 8.3. Method of Assigning Patients to Treatment Groups ....................................................................... 47 8.4. Dose, Dosing Regimen, and Route ................................................................................................. 47 8.4.1. G1T28 ........................................................................................................................... 47 8.4.2. Placebo
Load more

Recommended publications
  • Positive Effects of Trilaciclib on Patient
    POSITIVE EFFECTS OF TRILACICLIB ON PATIENT MYELOSUPPRESSION-RELATED SYMPTOMS AND FUNCTIONING: RESULTS FROM THREE PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED SMALL CELL LUNG CANCER TRIALS J Weiss1, K Skaltsa2, C Gwaltney2, D Daniel3, S Adler4, S Wolfe4, RK Malik4, SR Morris4, JM Antal4, Z Andric5 UNC Lineberger Comprehensive Cancer Center1; IQVIA2; Sarah Cannon, Tennessee Oncology – Chattanooga3; G1 Therapeutics4; Clinical Hospital Centre Bezanijska Kosa5 Conflict of Interest Disclosure Shannon Morris, MD, PhD • Salary: G1Therapeutics • Receipt of Intellectual Property Rights/Patent Holder: GlaxoSmithKline • Ownership Interest (stocks, stock options or other ownership interest excluding diversified mutual funds): G1 Therapeutics, GlaxoSmithKline Myelosuppression: despite the availability of interventions like G-CSF, ESAs and transfusions, there is still significant unmet medical need for patients 1st Line SCLC 2nd Line SCLC Current Incidence of Incidence of Current Unmet Needs Interventions Grade 3/41 Grade 3/42 ~70% bone pain (~25% severe3) induced by G-CSFs 54% Neutropenia 23% G-CSF (severe pain treated with NSAIDs, antihistamines, (3% FN) and opioids) Box warning for shortened overall survival and ESA rescue, Anemia 14% 31% increased risk of tumor progression; increased risk transfusion rescue of thromboembolic disease Thrombocytopenia 10% 54% Transfusion rescue No options other than transfusions Trilaciclib has the potential to prevent multi-lineage myelosuppression and reduce the need for these interventions and their associated side effects Sources: 1IMpower133 Trial, atezolizumab + E/P arm (n=198), NEJM, 2018; 2von Pawel J, et al. J Clin. Oncol. 2014;32:4012-4019; 2Kirshner et al: Prevention of pegfilgrastim-induced bone pain. JCO, 2012. Trilaciclib, a First-in-Class Myelopreservation Agent, Improves Patient Outcomes when Combined with Chemotherapy SCLC HSPC Trilaciclib transiently blocks progression through the cell cycle, thereby protecting HSPCs from damage by chemotherapy .
    [Show full text]
  • Investor Day March 6, 2019
    Investor Day March 6, 2019 www.g1therapeutics.com NASDAQ: GTHX 1 Forward-looking statements This presentation and the accompanying oral commentary contain “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this presentation include, but are not limited to the following: the therapeutic potential of trilaciclib, lerociclib and G1T48; initial success in our ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; our development of trilaciclib to reduce chemotherapy-induced myelosuppression is novel, unproven and rapidly evolving and may never lead to a marketable product; our product candidates may cause undesirable side effects that could delay or prevent their marketing approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any; we may not have the ability to recruit, enroll and complete clinical trials for, obtain approvals for, or commercialize any of our product candidates; we face substantial competition, which may result in others discovering, developing or commercializing competing products before or more successfully than we do; we may incur additional costs or experience delays in completing clinical trials; future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain; and market conditions.
    [Show full text]
  • G1 Therapeutics Presents Two Posters at ISPOR Describing The
    G1 Therapeutics Presents Two Posters at ISPOR Describing the Estimated Economic Impact of Treating Myelosuppression Among Patients with Extensive-Stage Small Cell Lung Cancer May 17, 2021 - A Cost-Benefit Model of Administration of COSELATM (trilaciclib) Prior to Chemotherapy Estimates Measurable Per-Patient Cost Savings - - Myelosuppression Poses a Substantial Burden on the Health Care System Among Patients with Small Cell Lung Cancer, According to an Analysis of SEER-Medicare Data - RESEARCH TRIANGLE PARK, N.C., May 17, 2021 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today presented two scientific posters at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) describing the estimated economic impact of treating myelosuppression among patients with extensive-stage small cell lung cancer. The posters are available in the scientific publications section of the G1’s website. COSELA was approved by the U.S. Food and Drug Administration on February 12, 2021 to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC. Cost-Benefit Analysis of Trilaciclib for the Prevention of Chemotherapy-Induced Myelosuppression in Extensive-Stage Small Cell Lung Cancer (Deniz, B. et al.) (poster) The first poster details a cost-benefit model estimating the economic value from a U.S. commercial payer perspective of using COSELA™ (trilaciclib) prior to chemotherapy in patients with extensive-stage small cell lung cancer (ES-SCLC). According to the model, the estimated potential total cost savings per patient is $15,006 – savings that are based on a projected reduction in myelosuppressive adverse events (AEs) and their associated treatment costs.
    [Show full text]
  • In Bladder Cancer
    G1 Therapeutics Initiates PRESERVE 3, A Randomized Phase 2 Study of COSELA™ (trilaciclib) in Bladder Cancer June 14, 2021 - The Primary Endpoint of PRESERVE 3 Will Assess the Anti-Tumor Efficacy of COSELA with Platinum-Based Chemotherapy Followed by COSELA in Combination with Immune Checkpoint Inhibitor Avelumab in 90 Patients with Metastatic Urothelial Carcinoma (mUC) - RESEARCH TRIANGLE PARK, N.C., June 14, 2021 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that the Company has initiated PRESERVE 3, a Phase 2, randomized, open-label study of COSELA™ (trilaciclib) administered with first-line platinum-based chemotherapy and the immune checkpoint inhibitor avelumab maintenance therapy in patients with untreated, locally advanced or metastatic urothelial carcinoma (mUC). Myeloprotection and anti-tumor efficacy endpoints are being assessed in this study. Initial results of this study are expected in the second half of 2022. “Bladder cancer is unfortunately common and the five-year survival rate for metastatic urothelial carcinoma has not changed in the last 25 years, highlighting the need for new and well tolerated therapies specifically tailored for immune sensitive tumors like this,” said Raj Malik, M.D., Chief Medical Officer at G1 Therapeutics. “While chemotherapy followed by avelumab maintenance therapy has proven to be a meaningful step forward for the 1L treatment of patients with mUC, patients may not receive the maximal benefit for a variety of reasons. These Phase 2 data will be instructional and important to evaluate the benefit of adding COSELA to this regimen, and if positive, would be quickly followed by a Phase 3 registrational trial.” Patient recruitment in Preserve 3 is now underway.
    [Show full text]
  • METASTATIC TRIPLE NEGATIVE BREAST CANCER (Mtnbc) PATIENTS: PRELIMINARY PHASE 2 RESULTS JOYCE OʼSHAUGHNESSY1, GAIL S
    ABSTRACT # 1191 TRILACICLIB, A CDK4/6 INHIBITOR, DOSED WITH GEMCITABINE, CARBOPLATIN IN METASTATIC TRIPLE NEGATIVE BREAST CANCER (mTNBC) PATIENTS: PRELIMINARY PHASE 2 RESULTS JOYCE OʼSHAUGHNESSY1, GAIL S. WRIGHT2, ANU R. THUMMALA3, MICHAEL A. DANSO4, LAZAR POPOVIC5, TIMOTHY J. PLUARD6, ERIC CHEUNG7, HYO SOOK HAN8, BROOKE R. DANIEL9, ZELJKO VOJNOVIC10, NIKOLA VASEV11, LING MA12, DONALD A. RICHARDS13, SHARON T. WILKS14, DUSAN MILENKOVIC15, JESSICA A. SORRENTINO16, PATRICK J. ROBERTS16, MELINDA M. BOMAR16, ZHAO YANG16, JOYCE M. ANTAL16, RAJESH K. MALIK16, SHANNON R. MORRIS16, ANTOINETTE R. TAN17 1TEXAS ONCOLOGY BAYLOR SAMMONS, US ONCOLOGY RESEARCH; 2FLORIDA CANCER SPECIALISTS (NORTH); 3COMPREHENSIVE CANCER CENTERS OF NEVADA, US ONCOLOGY RESEARCH; 4VIRGINIA ONCOLOGY ASSOCIATES, US ONCOLOGY RESEARCH; 5ONCOLOGY INSTITUTE OF VOJVODINA, UNIVERSITY OF NOVI SAD, SERBIA; 6SAINT LUKEʼS CANCER INSTITUTE; 7INNOVATIVE CLINICAL RESEARCH INSTITUTE; 8MOFFITT CANCER CENTER; 9TENNESSEE ONCOLOGY – CHATTANOOGA; 10COUNTY HOSPITAL VARAZDIN; 11UNIVERSITY CLINIC OF RADIOTHERAPY AND ONCOLOGY; 12ROCKY MOUNTAIN CANCER CENTERS, US ONCOLOGY RESEARCH; 13TEXAS ONCOLOGY TYLER, US ONCOLOGY RESEARCH; 14TEXAS ONCOLOGY SAN ANTONIO NORTHEAST, US ONCOLOGY RESEARCH; 15CLINICAL CENTER NIS, CLINIC OF ONCOLOGY; 16G1 THERAPEUTICS; 17LEVINE CANCER INSTITUTE, ATRIUM HEALTH BACKGROUND RESULTS TABLE 1. TRILACICLIB DIFFERS FROM APPROVED CDK4/6 INHIBITORS TABLE 2. DEMOGRAPHICS AND BASELINE DISEASE CHARACTERISTICS TABLE 4. PROSPECTIVELY DEFINED MYELOSUPPRESSION ENDPOINTS FIGURE 5. INCIDENCE
    [Show full text]
  • G1 Therapeutics Provides First Quarter 2020 Corporate and Financial Update
    G1 Therapeutics Provides First Quarter 2020 Corporate and Financial Update May 6, 2020 New Drug Application (NDA) submission for trilaciclib in small cell lung cancer on track for 2Q20 Rintodestrant combination trial with palbociclib expected to initiate in 2Q20 Management to host webcast and conference call today at 4:30 p.m. ET RESEARCH TRIANGLE PARK, N.C., May 06, 2020 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today provided a corporate and financial update for the first quarter ended March 31, 2020. “We have activated business continuity plans in response to the COVID-19 pandemic to ensure we can advance therapies that patients with cancer, their families, and healthcare providers are counting on to improve outcomes, and also taken actions to safeguard the well-being of our employees,” said Mark Velleca, M.D., Ph.D., Chief Executive Officer. “We are on track to complete a New Drug Application filing for trilaciclib for patients with small cell lung cancer this quarter, and have initiated virtual medical education programs as we prepare for commercial launch in the U.S. We remain committed to evaluating the benefits of trilaciclib in other indications and expect to initiate the I SPY-2 breast cancer trial this quarter and a pivotal trial in colorectal cancer in the fourth quarter of 2020. Cancer patients experiencing chemotherapy-induced myelosuppression are an especially vulnerable population, and trilaciclib has the potential to be the first proactively administered myelopreservation therapy for these patients.” First Quarter Regulatory, Clinical and Corporate Highlights NDA submission for trilaciclib in small cell lung cancer (SCLC) expected in 2Q20.
    [Show full text]
  • G1 Corporate Presentation
    Next Generation Cancer Therapies November 2019 NASDAQ: GTHX 1 Forward-looking statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this presentation include, but are not limited to, the therapeutic potential of trilaciclib, lerociclib and G1T48, the expected timing of data availability from ongoing clinical trials, the expected timing of initiation of future clinical trials, and the timing for the commencement and completion of marketing applications in the U.S. and Europe for trilaciclib in SCLC, and are based on the Company’s expectations and assumptions as of the date of this presentation. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the Company’s actual results to differ from those expressed or implied in the forward-looking statements in this presentation are discussed in the Company’s filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, the Company’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the Company’s initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; the Company’s development of a CDK4/6 inhibitor to reduce chemotherapy-induced myelosuppression is novel, unproven and rapidly evolving and may never lead to a marketable product; and market conditions.
    [Show full text]
  • G1 Therapeutics Announces Initiation of Phase 1B/2 Clinical Trial of G1T38 in Combination with Tagrisso for EGFR-Mutant Non-Small Cell Lung Cancer
    G1 Therapeutics Announces Initiation of Phase 1b/2 Clinical Trial of G1T38 in Combination with Tagrisso for EGFR-Mutant Non-Small Cell Lung Cancer April 16, 2018 RESEARCH TRIANGLE PARK, N.C., April 16, 2018 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq:GTHX), a clinical-stage oncology company, today announced that it has initiated a Phase 1b/2 clinical trial assessing G1T38, its oral CDK4/6 inhibitor, in combination with Tagrisso® (osimertinib) in people with EGFR-mutant (EGFRm) non-small cell lung cancer (NSCLC). AstraZeneca (LON: AZN) is providing Tagrisso for this trial under a non-exclusive clinical trial collaboration agreement. “G1T38 inhibits tumor cell growth, providing a rationale for combining it with other targeted therapies, including EGFR-TKI inhibitors such as Tagrisso. In a prior Phase 1a trial, G1T38 had no dose-limiting toxicities and was well tolerated with no impact on liver or cardiovascular function, presenting evidence of a favorable safety and tolerability profile for combination therapy,” said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D of G1 Therapeutics. “Despite advances in care, lung cancer remains the leading cause of cancer death globally. Non-small cell lung cancer represents the majority of lung cancers, and there is a significant need for new treatment options that improve outcomes for people with this disease.” The open-label trial is expected to enroll approximately 145 participants in two parts: a safety, pharmacokinetic and dose-finding portion (Part 1); and a subsequent randomized portion (Part 2). Primary outcome measures include safety and tolerability, identifying a recommended Phase 2 dose and progression-free survival (PFS).
    [Show full text]
  • Effect of Trilaciclib, a CDK 4/6 Inhibitor, on Myelosuppression in Patients with Previously Treated Extensive-Stage Small Cell Lung Cancer
    Effect of Trilaciclib, a CDK 4/6 Inhibitor, on Myelosuppression in Patients with Previously Treated Extensive-Stage Small Cell Lung Cancer Lowell L. Hart1,2,3, Zoran Gojko Andric4, Maen A. Hussein1,5, Renata Ferrarotto6, J. Thaddeus Beck7, Janakiraman Subramanian8, Davorin Z. Radosavljevic9, Dragana Jovanovic10, Krishna Kishore Pachipala11, Miroslav Samarzija12, Bojan Zaric13, Wahid Tewfik Hanna14, Raid Aljumaily1,15, Taofeek Kunle Owonikoko16, Rajesh K. Malik17, Shannon R. Morris17, Misha L. Johnson17, Zhao Yang17, Steven Adler17 and David R. Spigel1,18 Sarah Cannon Research Institute, Nashville, TN1; Florida Cancer Specialists and Research Institute, Fort Myers, FL2; Wake Forest University School of Medicine, Winston-Salem, NC3; Clinical Hospital Center, Bezanijska Kosa, Belgrade, Serbia4; Florida Cancer Specialists and Research Institute, Tavares, FL5; The University of Texas MD Anderson Cancer Center, Houston, TX6; Highlands Oncology Group, Rogers, AR7; Hanna Cancer Associates, Knoxville, TN8; Institute for Oncology and Radiology of Serbia Clinic for Medical Oncology, Belgrade, Serbia9; Clinic for Pulmonary Diseases, Clinical Center of Serbia, Belgrade, Serbia10; Millennium Oncology, Woodlands, TX11; University Hospital Centre Zagreb, Zagreb, Croatia12; Faculty of Medicine, University of Novi Sad Institute for Pulmonary Diseases of Vojvodina, Sremska Kamenica, Serbia13; University of Tennessee Graduate School of Medicine, Knoxville, TN14; Stephenson Cancer Center, University of Oklahoma HSC15; Emory University, Atlanta, GA16; G1 Therapeutics, Inc., Research Triangle Park, NC17 and Tennessee Oncology, Nashville, TN18 Lowell Hart, MD, FACP 1 Conflict of Interest Disclosure – Lowell Hart, MD, FACP THIS AUTHOR HAS PROVIDED THE FOLLOWING RELATIONSHIPS WITH COMPANIES THROUGH ASCO’S DISCLOSURE MANAGEMENT SYSTEM. • All authors provide information for 11 disclosure categories. • If no disclosure information appears below, the author indicated no Relationships with Companies.
    [Show full text]
  • Breast Cancer
    NASDAQ: GTHX Next Generation Cancer Therapies March 2020 NASDAQ: GTHX | 1 Forward-looking statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward- looking statements. Forward-looking statements in this presentation include, but are not limited to, those relating to the therapeutic potential of trilaciclib, rintodestrant and lerociclib, the timing of marketing applications in the U.S. and Europe for trilaciclib in SCLC, trilaciclib’s possibility to improve patient outcomes across multiple indications, rintodestrant’s potential to be best-in-class oral SERD, lerociclib’s differentiated safety and tolerability profile over other marketed CDK4/6 inhibitors and the impact of pandemics such as COVID-19 (coronavirus), are based on the company’s expectations and assumptions as of the date of this presentation. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the company’s actual results to differ from those expressed or implied in the forward-looking statements in this presentation are discussed in the company’s filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, the company’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the company’s initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; and market conditions.
    [Show full text]
  • Trilaciclib (G1t28): a Cyclin Dependent Kinase 4/6 Inhibitor, in Combination with Etoposide and Carboplatin
    ABSTRACT #194528 TRILACICLIB (G1T28): A CYCLIN DEPENDENT KINASE 4/6 INHIBITOR, IN COMBINATION WITH ETOPOSIDE AND CARBOPLATIN (EP) FOR EXTENSIVE STAGE SMALL CELL LUNG CANCER (ES-SCLC): PHASE 1b RESULTS CAIO MAX S. ROCHA LIMA1, PATRICK J. ROBERTS2, VICTOR M. PRIEGO3, STEPHEN G. DIVERS4, R. TIMOTHY WEBB4, MELANIE B. THOMAS1, RALPH V. BOCCIA3, KATIE STABLER2, ELIZABETH ANDREWS2, RAJESH K. MALIK2, RAID ALJUMAILY5, JOHN TURNER HAMM6, VI K. CHIU7, DONALD A. RICHARDS8, PETROS NIKOLINAKOS9, MAEN A. HUSSEIN10, STEVEN ROBERT SCHUSTER11, ROBERT JOHN HOYER12, GEOFFREY SHAPIRO13, KONSTANTIN H. DRAGNEV14, TAOFEEK KUNLE OWONIKOKO15 1GIBBS CANCER CENTER AND RESEARCH INSTITUTE, SPARTANBURG, SC; 2G1 THERAPEUTICS, INC., RESEARCH TRIANGLE PARK, NC; 3CENTER FOR CANCER AND BLOOD DISORDERS, BETHESDA, MD; 4GENESIS CANCER CENTER, HOT SPRINGS, AR; 5OKLAHOMA UNIVERSITY MEDICAL CENTER, OKLAHOMA CITY, OK; 6NORTON HEALTHCARE, LOUISVILLE, KY; 7UNIVERSITY OF NEW MEXICO COMPREHENSIVE CANCER CENTER, ALBUQUERQUE, NM; 8TEXAS ONCOLOGY, TYLER, TX; 9UNIVERSITY CANCER AND BLOOD CENTER, LLC, ATHENS, GA; 10FLORIDA CANCER SPECIALISTS AND RESEARCH INSTITUTE, LEESBURG, FL; 11UNIVERSITY OF COLORADO, FORT COLLINS, CO; 12MEMORIAL HOSPITAL - UNIVERSITY OF COLORADO HEALTH, COLORADO SPRINGS, CO; 13DANA-FARBER CANCER INSTITUTE, BOSTON, MA; 14DARTMOUTH-HITCHCOCK MEDICAL CENTER, LEBANON, NH; 15EMORY UNIVERSITY, ATLANTA, GA BACKGROUND STUDY OBJECTIVES RESULTS • Chemotherapy-induced toxicity to the bone marrow and immune system has significant acute PRIMARY OBJECTIVES TABLE 1. SUMMARY OF STUDY
    [Show full text]
  • Myeloprotection
    For people with small cell lung cancer who are receiving certain types of chemotherapy MYELOPROTECTION: (my-low-proh-TEK-shun) A big word that means: helping protect the blood-forming cells in your bone marrow from a harmful side effect of chemotherapy called “bone marrow suppression.” COSELA™ (trilaciclib) can help protect these cells and lower your risk of bone marrow suppression. INDICATION COSELA is a prescription medicine used to help reduce the occurrence of low blood cell counts caused by damage to bone marrow from chemotherapy. COSELA is used to treat adults taking certain chemotherapies (platinum/etoposide or topotecan) for extensive-stage small cell lung cancer. COSELA is an injection for intravenous (IV) use given within 4 hours before chemotherapy. IMPORTANT SAFETY INFORMATION Do not take COSELA if you have had a serious allergic reaction to COSELA. Please see additional Important Safety Information throughout this brochure. This information is not comprehensive. Please see the full Prescribing Information. With MYELOPROTECTION: My course of chemotherapy begins with helping protect My bone marrow from damage, so My body can continue making the blood cells I need, so My risk of bone marrow suppression is lower Learn about COSELA™ COSELA™ (trilaciclib) is a medicine that’s used to help protect against bone marrow suppression caused by chemo. Doctors and nurses call this “myeloprotection.” COSELA works to keep some of your blood cell counts from dropping too low while you’re getting your chemo. Chemo and your bone marrow ......................................................... 4 What is COSELA? ................................................................................ 6 How could COSELA work for you? ................................................... 8 What to expect with COSELA ...........................................................
    [Show full text]