Efficacy and Safety Study of Cediranib in Combination With Olaparib in Patients With Recurrent Platinum-Resistant Ovarian Cancer

Conditions

• Recurrent Platinum Resistant Ovarian Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 120 Years

Healthy Volunteers

Not accepted

Interventions

• cediranib and olaparib — DRUG
  Cediranib tablets oral dose 30 mg once daily; Olaparib(Lynparza) tablet 200 mg twice daily Dose reduction for both products is allowed

Study Details

This is an open label, single arm, multi-center study to assess the efficacy and safety of the combination of cediranib and olaparib tablets in platinum-resistant relapsed high grade serous, high grade endometroid or clear cell ovarian, fallopian tube or primary peritoneal carcinoma patients who have received at least 3 prior lines of chemotherapy and who do not carry deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA) mutations.

Key Dates

Start date

Jan 17, 2017

Status verified

Mar 2022

Primary completion

Aug 27, 2019

Completion

Mar 16, 2021

Study Design

Enrollment

62 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: combination of cediranib and olaparib
  Open label

Primary Outcome Measure

Mean Objective Response Rate (ORR) by Independent Central Review (ICR) Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: From baseline to primary analysis DCO (8 months after last patient received their first dose of IPs). RECIST assessments were performed at baseline and every 8 weeks (+/- 1 week) after first doses of IPs until disease progression. ]

Locations (25)

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