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Clinical Trial Details (PDF Generation Date :- Sat, 02 Oct 2021 02:27:49 GMT)

CTRI Number CTRI/2017/11/010582 [Registered on: 21/11/2017] - Trial Registered Retrospectively Last Modified On 20/08/2019 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Study Design Randomized, Parallel Group, Active Controlled Trial Public Title of Study A clinical trial to study the effects of study drug for treatment of low concentration of Neutrophils caused due to Chemotherapy given to patients suffering from early stage breast cancer. Scientific Title of Randomized, Open-Label, Active-Control Trial of SPI-2012 (Eflapegrastim) Versus in Study the Management of Chemotherapy-Induced Neutropenia in Early-Stage Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) (RECOVER) Secondary IDs if Any Secondary ID Identifier SPI-GCF-302 Version Original dated 27 Sep Protocol Number 2016 Details of Principal Details of Principal Investigator Investigator or overall Name Dr Tarini Joshi Trial Coordinator (multi-center study) Designation Medical Advisor Affiliation Spectrum Oncology Pvt Ltd Address Department of clinical operations, Office no. 71, Free Press House, 215, Free Press Journal Marg, Nariman point Mumbai MAHARASHTRA 400021 India Phone 02222042380 Fax 02222022380 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Tarini Joshi Query) Designation Medical Advisor Affiliation Spectrum Oncology Pvt Ltd Address Department of Clinical operations, Office no. 71, Free Press House, 215, Free Press Journal Marg, Nariman point Mumbai MAHARASHTRA 400021 India Phone 02222042380 Fax 02222022380 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Gaurav Kadam Designation Clinical Operation Manager Affiliation Spectrum Oncology Pvt Ltd Address Department of Clinical Operations, Office no. 71, Free Press House, 215, Free Press Journal Marg, Nariman point Mumbai MAHARASHTRA 400021

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India Phone 02222042380 Fax 02222022380 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Spectrum Pharmaceuticals Inc, 157, Technology Drive, Irvine, CA 92618, USA Primary Sponsor Primary Sponsor Details Name Spectrum Pharmaceuticals Inc Address 157, Technology Drive, Irvine, CA 92618 Type of Sponsor Pharmaceutical industry-Global Details of Secondary Name Address Sponsor Spectrum Oncology Pvt Ltd 71, Free Press House, 215, Free Press Journal Marg, Nariman Point, Mumbai - 400021, Maharashtra, India. Countries of List of Countries Recruitment Canada Hungary India Poland United States of America Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr K Pavithran Amrita Institute of AIMS Ponekkara P.O., 9895367090 Medical Sciences Cochin- 682041 Ernakulam [email protected] KERALA a.edu Dr Rajesh Balakrishnan Christian Medical Department of 9442169744 College radiotherapy, Unit III, CMC, Ida Scudder [email protected]. Road, Vellore - 632004 in Vellore TAMIL NADU Dr Suresh Advani Jaslok Hospital & Department of Medical 02266573232 Research Centre Oncology 15, Dr G. Deshmukh Marg, shadvani2000@yahoo. Mumbai- 400062 com Mumbai MAHARASHTRA Dr Minish Jain KEM Hospital Research Department of Medical 9823133390 Centre Oncology, Sardar Moodliar Road, Rasta [email protected] Peth, Pune- 411011 Pune MAHARASHTRA Dr Rajesh Singh Regional Cancer centre Indira Gandhi Institute 9939088899 of Medical Sciences, Sheikhpura, Patna - [email protected] 800014 om Patna BIHAR Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee?

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Institutional Ethics Approved 17/10/2017 No committee Institutional Ethics Approved 17/11/2017 No committee Vellore KEM Hospital Research Approved 21/10/2017 No Centre Ethics Committee Regulatory Clearance Status Date Status from DCGI Approved/Obtained 20/07/2017 Health Condition / Health Type Condition Problems Studied Patients Early Stage Breast Cancer Patients Malignant neoplasm of breast of unspecified site Intervention / Type Name Details Comparator Agent Intervention SPI-2012 (Eflapegrastim) SPI-2012 (Eflapegrastim) is a novel biologic that was produced using the proprietary long-acting protein/peptide discovery technology (LAPSCOVERY™), which was designed to maximize the pharmacologic activity of the granulocyte-colony stimulating factor (G-CSF) moiety of the molecule. SPI-2012 (Eflapegrastim) stimulates the formation, release, and function of neutrophils. It acts by binding to a receptor on myeloid progenitor cells and neutrophils, and triggers signaling pathways that control cell survival, proliferation, differentiation, and migration of neutrophil precursors and mature neutrophils. Comparator Agent Neulasta (Pegfilgrastim) Neulasta is a leukocyte growth factor indicated to Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 99.00 Year(s) Gender Both Details 1. Patient must have a newly diagnosed, histologically confirmed early-stage breast cancer (ESBC), defined as operable Stage I to Stage IIIA breast cancer.
2. Patient must be a candidate to receive adjuvant or neoadjuvant TC chemotherapy.
3. Patient must have adequate hematological, renal and hepatic function
4. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ?2.
5. Females of childbearing

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potential must have a negative urine pregnancy test within 30 days prior to randomization Exclusion Criteria Exclusion Criteria Details 1. Patient with an active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life-threatening disease. If there is a history of prior malignancies, the patient must be disease free for at least 5 years 2. Patient with known sensitivity or previous reaction to Escherichia coli (E. coli) derived products (eg, , recombinant insulin [Humulin®], L-asparaginase, somatropin [Humatrop®] growth hormone, recombinant alfa-2b [Intron® A]), or any of the products to be administered during study participation. 3. Patient with concurrent adjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial-specified therapies). 4. Patient has locally recurrent/metastatic or contralateral breast cancer 5. Patient with previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development prior to the administration of study drug (SPI-2012 or pegfilgrastim). 6. Patient with an active infection or receiving anti-infectives, an underlying medical condition, or another serious illness that would impair the ability of the patient to receive protocol-specified treatment. 7. Patient has used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study. 8. Patient has had prior bone marrow or hematopoietic stem cell transplant. 9. Patient has had prior radiation therapy within 30 days prior to enrollment. 10. Patient has had major surgery within 30 days prior to enrollment. Patients who have breast surgery related to the breast cancer diagnosis or have had a port-a-cath placement may be enrolled prior to 30 days once they have fully recovered from the procedure. 11. Patient is pregnant or breast-feeding Method of Generating Computer generated randomization Random Sequence Method of An Open list of random numbers Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints To compare the efficacy of a single dose of Duration of Severe Neutropenia (DSN) in Cycle SPI-2012 with pegfilgrastim in patients with 1 early-stage breast cancer receiving docetaxel and cyclophosphamide (TC), as measured by the Duration of Severe Neutropenia (DSN) in Cycle 1 Secondary Outcome Outcome Timepoints To compare SPI-2012 with pegfilgrastim in: End of Cycle 1 1. Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1 2. Depth of ANC Nadir, defined as the patient’s lowest ANC in Cycle 1 3. Incidence of Febrile Neutropenia (FN) in patients during Cycle 1 Target Sample Size Total Sample Size=218

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Sample Size from India=50 Final Enrollment numbers achieved (Total)=237 Final Enrollment numbers achieved (India)=8 Phase of Trial Phase 3 Date of First 01/10/2017 Enrollment (India) Date of First 10/05/2017 Enrollment (Global) Estimated Duration of Years=2 Trial Months=0 Days=0 Recruitment Status of Completed Trial (Global) Recruitment Status of Completed Trial (India) Publication Details Information regarding use or publication of study-related information will be provided to the Investigator in the Clinical Trial Agreement. Brief Summary This is a Phase 3, randomized, open-label, active-controlled, multicenter study to compare the efficacy and safety of SPI-2012 with pegfilgrastim in breast cancer patients treated with TC chemotherapy.

Approximately 218 patients will be enrolled and randomized in a 1:1 ratio to 2 treatment arms

Treatment Arm 1 (n= approximately 109): SPI-2012 (13.2 mg/0.6 mL fixed dose SPI-2012 equivalent to 3.6 mg G-CSF)

Treatment Arm 2 (n= approximately 109): Pegfilgrastim (6 mg/0.6 mL)

Prior to TC chemotherapy administration, patients may receive premedication according to institutional standard of care. Intravenous (IV) administration of TC on Day 1 of each cycle will be as follows:

Docetaxel 75 mg/m2 IV infusion per institute’s standard of care

Cyclophosphamide 600 mg/m2 IV infusion per institute’s standard of care

Each cycle will be 21 days. Only 4 cycles will be evaluated for this study. After Cycle 1, patients must have ANC ?1.5×109/L and platelet count ?100×109/L to begin each of the next cycles of chemotherapy.

The study drug (SPI-2012 or pegfilgrastim) will be administered on

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Day 2 of each cycle, approximately 24 to 26 hours after the last dose of TC chemotherapy is given. Study drug (SPI-2012 or pegfilgrastim) dose modifications are not allowed.

On Day 1 of each cycle, patients will receive TC chemotherapy, and safety and efficacy assessments will be performed as outlined in the protocol. On Day 2 of each cycle, patients will receive study drug (SPI-2012 or pegfilgrastim), and the specified assessments will be performed.

Absolute neutrophil count will be monitored on Day 1 and Days 4 to 15 in Cycle 1. In Cycles 2 to 4, all patients must have blood samples drawn on Day 1 (prior to chemotherapy administration), on Days 4, 7, 10, and 15 (±1 day for each collection), and at the End-of-Treatment Visit. If the participating site is notified that the ANC is ?1.0×109/L at any time during Cycles 2 to 4, then daily CBCs will be required until the ANC is ?1.5×109/L, after reaching nadir, but blood samples must still be drawn on Days 4, 7, 10, and 15.

After Cycle 1, as applicable, patients who have received at least one dose of study drug will be followed for 12 months after the last dose of study treatment for safety follow-up.

Duration of Study: Approximately 28 months with 16 months for enrollment and treatment and 12 months for safety follow-up.

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