BENITIONSClinical Trial Intelligence

Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Phase 3 Active, not recruiting NCT02446600

ConditionFallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Transitional Cell Carcinoma, Fallopian Tube Undifferentiated Carcinoma, Ovarian Clear Cell Adenocarcinoma
PhasePhase 3
SponsorNational Cancer Institute (NCI)
StatusActive, not recruiting
Enrollment579 participants
InterventionsBiospecimen Collection, Carboplatin, Cediranib Maleate, Computed Tomography, Echocardiography Test
Start dateMar 28, 2016
Completion dateFeb 23, 2020
Results postedMar 12, 2021

Summary

This phase III trial studies olaparib or cediranib maleate and olaparib to see how well they work compared with standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer that has come back. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may stop the growth of ovarian, fallopian tube, or primary peritoneal cancer by blocking the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine hydrochloride, and pegylated liposomal doxorubicin hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether olaparib or cediranib maleate and olaparib is more effective than standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.

Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria

The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. An average of approximately 10 months. · months

Arm I (Platinum-based Chemotherapy)10.3 months
Arm II (Olaparib)8.2 months
Arm III (Olaparib, Cediranib Maleate)10.4 months
p-value0.077
Hazard Ratio (HR)0.856 (95% CI 0.663–1.105)

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