A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors.
Condition(s) studied
Investigational drug(s) / intervention(s)
Olaparib: Olaparib
MEDI4736: MEDI4736
Bevacizumab: Bevacizumab
Study summary
The purpose of this study is to look at the effectiveness, safety, and antitumor activity of study drugs MEDI4736 in combination with olaparib (modules 1, 2, 3, 4, 5 and 7) and MEDI4736 in combination with olaparib and bevacizumab (module 6). It will also examine what happens to the study drugs in the body and investigate how well the combination between MEDI4736, olaparib and bevacizumab is tolerated.
Eligibility
Primary outcome measure(s)
- Initial Stage Cohorts: Disease Control Rate (DCR) at Week 12 — RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019.
The DCR at 12 weeks was defined as the percentage of participants who had complete response (CR) + partial response (PR) + stable disease (SD) at 12 weeks. Participants demonstrated SD for a minimum interval of 11 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 77 days) following the start of treatment. The DCR was determined using Investigator assessments according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). - Second Stage Cohort: Objective Response Rate (ORR) — RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.
The ORR (based on RECIST 1.1 as assessed by the Investigator) was defined as the percentage of participants with at least 1 visit response of CR or PR prior to PD or last evaluable assessment in the absence of progression. The 95% confidence interval (CI) were calculated using Exact Clopper-Pearson confidence limits for the binomial proportion. - Second Stage Cohorts: DCR at Week 24 — RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.
The DCR at 24 weeks was defined as the percentage of participants who had CR + PR + SD at 24 weeks. Participants demonstrated SD for a minimum interval of 23 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 161 days) following the start of treatment. The DCR was determined using Investigator assessments according to RECIST v1.1.
Trial sites (47)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Newnan | Georgia | |
| Research Site | Towson | Maryland | |
| Research Site | Boston | Massachusetts | |
| Research Site | Detroit | Michigan | |
| Research Site | St Louis | Missouri | |
| Research Site | Hilliard | Ohio | |
| Research Site | Philadelphia | Pennsylvania | |
| Research Site | Bordeaux | France | |
| Research Site | Caen | France | |
| Research Site | Clermont-Ferrand | France | |
| Research Site | Dijon | France | |
| Research Site | Marseille | France | |
| Research Site | Nantes | France | |
| Research Site | Paris | France | |
| Research Site | Pierre Benit Cedex | France | |
| Research Site | Toulouse | France | |
| Research Site | Villejuif | France | |
| Research Site | Haifa | Israel | |
| Research Site | Jerusalem | Israel | |
| Research Site | Petah Tikva | Israel | |
| Research Site | Ramat Gan | Israel | |
| Research Site | Tel Aviv | Israel | |
| Research Site | Amsterdam | Netherlands | |
| Research Site | Amsterdam | Netherlands | |
| Research Site | Maastricht | Netherlands | |
| Research Site | Nijmegen | Netherlands | |
| Research Site | Rotterdam | Netherlands | |
| Research Site | Utrecht | Netherlands | |
| Research Site | Goyang-si | South Korea | |
| Research Site | Seongnam-si | South Korea | |
| Research Site | Seoul | South Korea | |
| Research Site | Seoul | South Korea | |
| Research Site | Seoul | South Korea | |
| Research Site | Seoul | South Korea | |
| Research Site | Seoul | South Korea | |
| Research Site | Seoul | South Korea | |
| Research Site | Chur | Switzerland | |
| Research Site | Lausanne | Switzerland | |
| Research Site | Cambridge | United Kingdom | |
| Research Site | Dundee | United Kingdom |
+ 7 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02734004 on ClinicalTrials.gov ↗ ← All trials in South Korea