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NCT02734004 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors.
A Phase 1 study of SCLC and Breast, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 1
- Development phase
- 264
- Enrollment target
- 20
- Study locations
NCT02734004: Active Phase 1 study of SCLC and Breast, sponsored by AstraZeneca.
NCT02734004 is a Phase 1 study of SCLC and Breast that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 264 participants, above the 169-participant average among 10 other SCLC trials with a reported enrollment target (56% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02734004, a Phase 1 study of SCLC and Breast, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 264 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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).
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG Olaparib
- DRUG MEDI4736
Study Locations (20)
Other
- Research Site - Bordeaux
- Research Site - Caen
- Research Site - Clermont-Ferrand
- Research Site - Dijon
- Research Site - Marseille
- Research Site - Nantes
- Research Site - Paris
- Research Site - Pierre Benit Cedex
- Research Site - Toulouse
- Research Site - Villejuif
- Research Site - Haifa
- Research Site - Jerusalem
- Research Site - Petah Tikva
Georgia
- Research Site - Newnan
Maryland
- Research Site - Towson
Massachusetts
- Research Site - Boston
Michigan
- Research Site - Detroit
Missouri
- Research Site - St Louis
Ohio
- Research Site - Hilliard
Pennsylvania
- Research Site - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 264 participants |
| Start Date | 2016-03-17 |
| Est. Completion | 2026-09-17 |
| Phase | Phase 1 |
What the registry record for NCT02734004 still lists
NCT02734004 is an interventional study that assigns participants to a tested intervention. The registered 264 participants enrollment target is mid-sized for trials with a published cap, above the 169-participant average among 10 other SCLC trials with a reported enrollment target (56% higher).
The record links to 4 conditions, with SCLC appearing as the primary indexed condition, and to 3 interventions - of which Bevacizumab is the first listed.
NCT02734004 names 20 study sites across 8 states, led by Other, Georgia, Maryland.
Frequently Asked Questions
What is clinical trial NCT02734004 about?
NCT02734004 is a clinical study titled "A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors.". 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 t...
What is the current status of trial NCT02734004?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 264 participants. The study started on 2016-03-17. Estimated completion is 2026-09-17.
What conditions does trial NCT02734004 study?
This clinical trial studies the following conditions: SCLC, Breast, Gastric Cancers, Ovarian.
What interventions are being tested in trial NCT02734004?
The interventions under investigation include: Bevacizumab (DRUG), Olaparib (DRUG), MEDI4736 (DRUG).
Who is sponsoring clinical trial NCT02734004?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02734004 being conducted?
This trial has 20 study locations across Georgia, Maryland, Massachusetts, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02734004's enrollment target sits among peer trials
264 2nd of 10 the highest of 10 other SCLC trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other SCLC trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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