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Clinical Study Protocol: Nucog I - Vingem

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Clinical Study Protocol: Nucog I - Vingem CLINICAL STUDY PROTOCOL: NUCOG I - VINGEM A multicenter, randomized phase II trial of vinflunine/gemcitabine versus carboplatin /gemcitabine as first line treatment in patients with metastatic urothelial carcinoma unfit for cisplatin based chemotherapy due to impaired renal function. EudraCT Number: 2013-002417-35 Protocol Version: 1.1 Date: August 2013 All information in this protocol is confidential. Page 1 Clinical Study Protocol: NUCOG I – VINGEM v 1.1, August 2013 Signature Principal Investigator: _____________________________________________ Date Signature PI _____________________________________________ Name in print Signature Sponsor: _______________________________________________________ Date Signature Sponsor Contact information Sponsor: Anders Ullén, MD, PhD Phone: +46-8-517 70 000 switch Fax: +46-8-517 795 24 E-mail: [email protected] All information in this protocol is confidential. Page 2 Clinical Study Protocol: NUCOG I – VINGEM v 1.1, August 2013 SYNOPSIS OF PROTOCOL NUCOG I - VINGEM Titel A multicenter, randomized phase II trial of vinflunine/gemcitabine versus carboplatin /gemcitabine as first line treatment in patients with metastatic urothelial carcinoma unfit for cisplatin based chemotherapy due to impaired renal function. Sponsor Investigator initiated study, NUCOG. Rational The standard first line treatment for patients with metastatic urothelial carcinoma unfit for cisplatin due to renal impairment is carboplatin containing chemotherapy, with a median overall survival of approximately 8-10 month. New, more effective regimens in terms of tumor control and quality of life are urgently needed. Vinflunine has proven efficacy in urothelial carcinoma and is registered as second line treatment. The combination of gemcitabine and vinflunine has not yet been evaluated in first line treatment for patients with metastatic urothelial carcinoma. Trial Design Multicenter, 1:1 randomized phase II screening design. Target Population First line treatment in patients with locally advanced or metastatic urothelial carcinoma, unfit for cisplatinbased chemotherapy due to impaired renal function, as per inclusion/exclusion criteria defined below. Objectives To compare the efficacy, safety and quality of life of vinflunine/gemcitabine and carboplatin/gemcitabine. End points Primary 1) 1) Progression-free survival (PFS) Secondary 1) 1) Overall response rate, ORR (= CR + PR) 2) Overall survival (OS) 3) Disease control rate, DCR (=CR + PR + SD) 4) Safety (Data on safety parameters) 5) Quality of Life (QoL) Number of patients 120 evaluable patients. Number of Centers >5 from different Nordic countries Selection criteria Inclusion Criteria Signed informed consent. Histological or cytological confirmed transitional cell carcinoma of the urothelial tract (mixed histology including transitional cell carcinoma are allowed). Unresectable (T4b), locally advanced (lymph node positive (N+)) or metastatic (M1) urothelial carcinoma (including renal pelvic tumours, ureteral tumours, urinary bladder tumours and urethral primary tumours). No prior chemotherapy or other anti-cancer drugs. Patients who have received neoadjuvant or adjuvant platinum containing chemotherapy and who are diagnosed with loco regional recurrent or metastatic disease after 6 months are eligible. Creatinine clearance 30 – 60 ml/min (measured by Iohexol or Cr-EDTA technique) ECOG/WHO Performance Status (PS) 0-1. All information in this protocol is confidential. Page 3 Clinical Study Protocol: NUCOG I – VINGEM v 1.1, August 2013 ≥ 4 weeks since prior surgery, ≥ 2 weeks since prior radiation therapy. Measurable and/or non-measurable disease using the RECIST criteria defined as: - Measurable disease: lesions that can be measured in at least one dimension and which have not been previously irradiated. Longest diameter 20 mm with conventional techniques or 10 mm with spiral CT scan or MRI. - Non-measurable disease: lesions which have not been previously irradiated, longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan or MRI, or truly non measurable lesions including bone lesions, ascites, pleural/pericardial effusion, and lymphangitis cutis/pulmonitis. CNS metastases and/or leptomeningeal metastases are allowed provided these have been adequately treated with radiotherapy are stable and not generating any symptoms. Spinal cord compression due to metastatic lesions is allowed provided adequate surgery and/or radiotherapy has been delivered, the metastases are stable and not generating any symptoms. No known or suspected allergy to the investigational agents or any agents given in association with this trial. 18 years of age or older. Fertile men and women of childbearing potential must use secure contraception (women - intrauterine devices, hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release), men – condom and for a female partner as described above) from before 2 months entering the study until 6 months after end of chemotherapy. Exclusion Criteria Not fulfilling inclusion criteria as described above Pure non-transitional cell carcinoma of the urothelial. Bleeding tumours. 9 Impaired bone marrow function defined as WBC < 3.0 x 10 /L, 9 9 neutrophils < 1.5 x 10 /L, platelets < 125 x 10 /L, haemoglobin < 100 g/L. Impaired liver function defined as serum bilirubin > 1.5 x upper limit of normal (ULN) and/or ASAT/ALAT > 2.5 x ULN (> 5 x ULN if known liver metastasis). Electrocardiogram (ECG) with significant modifications suggesting a high risk of occurrence of angina pectoris or high risk of arrhythmia. Other malignancies, except adequately treated basal carcinoma or squamos cell carcinoma of the skin or in-situ cervix carcinoma or incidental prostate cancer (T1a, Gleason score ≤ 6, All information in this protocol is confidential. Page 4 Clinical Study Protocol: NUCOG I – VINGEM v 1.1, August 2013 PSA < 0.5 ng/ml), or any other tumour with a disease free survival of ≥ 5 years. History of serious or concurrent illness or uncontrolled medical disorder; any medical condition that might be aggravated by chemotherapy treatment or which could not be controlled; including, but not restricted to: - Active infection requiring antibiotics within 2 weeks before the study inclusion, - Unstable diabetes mellitus, - Hypercalcaemia >2.9 mmol/L (= grade 2 according to CTCAE v 4.0), - Concurrent congestive heart failure NYHA (class III- IV), - Unstable angina pectoris, or myocardial infarction within 6 months and/or poorly controlled hypertension, - QTc > 450 ms at baseline, - Inflammatory bowel disease, - Peripheral neuropathy grade 2 according to CTCAE v 4.0, Patients who require treatment with ketoconazole, itraconazole, ritonavir, amprenavir, indinavir, rifampicine (any potent CYP3A4 inhibitor or inducer) or phenytoine. Pregnant or lactating women. Any psychological, familial, sociological, or geographical condition which does not permit protocol compliance and medical follow-up. Investigational 50% of the patients will receive vinflunine in combination with Drugs gemcitabine. Dose/Route/Regimen Vinflunine: 250 mg/m2 for patients with age > 80 years and/or GFR 30-40 ml/min, given I.V. on day 1, repeated every 21 days. 280 mg/m2 for patients with GFR 40-60 ml/min, given I.V. on day 1, repeated every 21 days. Gemcitabine: 1000 mg/m2 given I.V. on day 1 and 8 of every 21 day cycle. All information in this protocol is confidential. Page 5 Clinical Study Protocol: NUCOG I – VINGEM v 1.1, August 2013 Reference Drugs 50% of the patients will receive carboplatin in combination with Dose/Route/Regimen gemcitabine. Carboplatin: AUC 4.5 given I.V. on day 1, repeated every 21 days. Gemcitabine: 1000 mg/m2 given I.V. on day 1 and 8 of every 21 day cycle. Duration of In both arms treatment continues until disease progression, treatment unacceptable toxicity or patient wish to stop treatment. Follow up Survival information will be collected every third month until death for both treatment arms. Sample size Primary endpoint is progression-free survival. The study is designed to detect a 50% increase in median PFS from 5 months to 7.5 months using a significance level of 10% and a power of 80%. To be able to detect a difference of this magnitude the study must observe 110 PFS-events. With an annual accrual rate of 60 patients per year during two years and an extra year of follow-up the study is expected to generate the necessary number of events within a three- year period. Statistical Analysis The study is designed as a nondefinitive randomized phase II screening trial, with the primary endpoint progression free survival (PFS). The Kaplan-Meier technique will be used to estimate PFS and differences in survival will be tested using the log-rank test. Treatment effect will be estimated using proportional hazards regression. Key dates Anticipated start of study: Q 3, 2013 Estimated recruitment period: Q 3, 2013 – Q 1, 2016 All information in this protocol is confidential. Page 6 Clinical Study Protocol: NUCOG I – VINGEM v 1.1, August 2013 TABLE OF CONTENTS 1 LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ............................................................... 11 2 GENERAL INFORMATION/STUDY ADMINISTRATIVE STRUCTURE ............................................ 12 2.1 Participating cancer centers ............................................................................................................................... 13 3 BACKGROUND .............................................................................................................................................
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