A Randomized, Open-label, Comparative, Multicenter, Phase II Study of the Efficacy and Safety of REGorafenib Versus Tamoxifen in Patients With Platinum-sensitive OVARian Carcinoma and Isolated Biological Progression

GINECO-OV235

The objective of this randomized phase II is to evaluate the benefit of regorafenib for ovarian patients who reported a confirmed elevated CA-125 level under surveillance or bevacizumab, compared with tamoxifen.

2015-08-28

2021-09-19

2021-09-19

Completed

Early phase I

68

Main Inclusion Criteria: I2 Histological confirmation of epithelial ovarian, fallopian tube, or primary peritoneal cancer, I3 Rising CA-125 (according to the Rustin/GCIG criteria, see appendix 10)) occurring more than 6 months after the last platinum-based chemotherapy cycle (platinum sensitive), I4 No symptom related to ovarian cancer progression, I6 1 or 2 prior lines of platinum-based chemotherapy followed either by surveillance or bevacizumab or olaparib (outside therapeutic trial) maintenance, I7 Before randomization, patients must be in CR, PR or SD (RECIST version 1.1) under surveillance or maintenance with bevacizumab or olaparib, I8 Adequate bone marrow, liver and renal functions as assessed by the following laboratory tests conducted within 7 days before randomization: * Absolute Neutrophil Count ≥ 1.5 G/L, platelets count ≥ 100 G/L, and hemoglobin ≥ 9g/dL, * AST/ALT ≤ 3 x upper limit of normal (ULN) (or ≤ 5.0 x ULN if liver metastasis) and total bilirubin ≤ 1.5 x ULN, Alkaline phosphatase ≤ 2.5 x ULN * Serum creatinine ≤ 1.5 x ULN, * Glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m² according to the Modification of Diet Renal Disease (MDRD) abbreviated formula * Lipase ≤ 1.5 x ULN * Prothrombine time-international normalized ratio (PT-INR) \< 1.5 x ULN. Patients who are therapeutically anticoagulated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in this parameter exists, I9 Women of childbearing potential and partners must agree to use adequate contraceptive method (if no previous bilateral annexectomies) during the whole study period and for up to 6 months after the last dose of study treatment; a negative pregnancy test must be obtained prior to randomization, Main Exclusion Criteria: E4 Past or concurrent history of neoplasm other than ovarian cancer, except for in situ carcinoma of the cervix uteri, in situ breast cancer and/or basal cell epithelioma. All treats and cures cancer more than 3 years before the study entry is allowed E5 Known history or symptomatic metastatic brain or meningeal tumors (head CT or MRI at screening to confirm the absence of central nervous system (CNS) disease if the patient has symptoms suggestive or consistent with progressive CNS disease), E6 Any prior radiotherapy to the pelvis or abdomen; surgery (including open biopsy) within 4 weeks before starting study drugs (24 hours for minor surgical procedures), or planned major surgery during the study treatment period, E7 Any prior treatment with anti angiogenic agent such as pazopanib, nintedanib or cediranib. E8 Endocrine therapy administered within 3 years prior to randomization, E13 History of any of the following : * abdominal fistula, * gastrointestinal perforation, * intra-abdominal abscess, * any malabsorption condition, E14 Clinically significant bleeding NCI-CTCAE version 4.3 Grade 3 or higher within 30 days before randomization, E15 Congestive heart failure New York Heart Association (NYHA) ≥ class 2, E17 Uncontrolled hypertension (systolic blood pressure (BP) \> 150 mmHg or diastolic pressure \> 90 mmHg despite optimal medical management), E21 Ongoing infection \> Grade 2 according to NCI-CTCAE version 4.3. Hepatitis B is allowed if no active replication is present. Hepatitis C is allowed if no antiviral treatment is required, E23 Interstitial lung disease with ongoing signs and symptoms at the time of screening,

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 68, 'type': 'ACTUAL'}}

2023-09-06