Autophagy as a Target for Therapy in Ovarian Cancer: A Phase II Randomized Trial with Biomarker Correlation - ATOC

Jawaharlal Institute of Postgraduate Medical Education and Research0 个研究点目标入组 59 人开始时间: 待定最近更新: 2023年10月16日

试验速览

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•1. Platinum-sensitive-relapsed-(serous-epithelial)-ovarian cancer planned for salvage chemotherapy with paclitaxel and carboplatin.
•2. Measurable disease (elevated CA-125 or measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria) at the time of study enrolment.
•3. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
•4. Acceptable bone marrow and organ function at screening as described below:
•a. ANC greater or equal to 1500/µL (without WBC growth factor support)
•b. Platelet count greater or equal to 75,000/µL;
•c. Haemoglobin greater or equal to 8 g/dL
•d. Total Bilirubin less than or equal to 1.5 mg/dl;
•e. AST (SGOT) less than or equal to 3 x ULN (as per JIPMER biochemistry) (less than or equal to 5 × ULN if known liver metastases)
•f. ALT (SGPT) less than or equal to 3 x ULN (as per JIPMER biochemistry) (less than or equal to (less than or equal to 5 × ULN if known liver metastases)
•g. Serum creatinine less than 2 mg/dL or a measured creatinine clearance greater than or equal to 50 mL/min according to Cockcroft-Gault formula
•5. Patients willing to give informed consent and comply with study procedures.

•1. Patients with Pre-existing retinal disease.
•2. Patients on Long term therapy with hydroxychloroquine.
•3. Prolonged corrected QTc interval in ECG >480ms.
•4. Patients planned for cytoreductive surgery at the time of relapse.
•5. Patients planned for bevacizumab or PARP inhibitor.
•6. Patients with serious intercurrent illnesses that will preclude the administration of protocol treatment.

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