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NCT02499328 · ClinicalTrials.gov registry record · Phase 1
Study to Assess MEDI4736 With Either AZD9150 or AZD5069 in Advanced Solid Tumors & Relapsed Metastatic Squamous Cell Carcinoma of Head & Neck
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 340
- Enrollment target
NCT02499328: Completed Phase 1 study, sponsored by AstraZeneca.
NCT02499328 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 340 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (467% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02499328, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 340 participants
- Enrollment target
Study Summary
This multicentre, open-label, Phase 1b/2 study is designed as a 2 part study consisting of a dose-escalation, safety run-in Part A and a dose-expansion Part B
Primary Outcome
After completion of DLT period (35 days) for the maximum dose cohort. A CRM-based approach was used to identify the set of dose combinations where the incidence of DLT was ≤ 33%. The dose with expected DLT incidence closest and below 0.33 at this point was the "model estimated" MTD. During trial execution, the Safety Review Committee (SRC) determined the MTD.
Interventions
- DRUG MEDI4736
- DRUG AZD9150
- DRUG AZD5069
- DRUG tremelimumab (treme)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 340 participants |
| Start Date | 2015-08-06 |
| Est. Completion | 2025-10-08 |
| Phase | Phase 1 |
What the finished NCT02499328 record still lists
NCT02499328 is an interventional study that assigns participants to a tested intervention. The registered 340 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (467% higher).
The record links to 0 conditions, and to 4 interventions - of which MEDI4736 is the first listed.
NCT02499328 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02499328 about?
NCT02499328 is a clinical study titled "Study to Assess MEDI4736 With Either AZD9150 or AZD5069 in Advanced Solid Tumors & Relapsed Metastatic Squamous Cell Carcinoma of Head & Neck". This multicentre, open-label, Phase 1b/2 study is designed as a 2 part study consisting of a dose-escalation, safety run-in Part A and a dose-expansion Part B
What is the current status of trial NCT02499328?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 340 participants. The study started on 2015-08-06. Estimated completion is 2025-10-08.
What interventions are being tested in trial NCT02499328?
The interventions under investigation include: MEDI4736 (DRUG), AZD9150 (DRUG), AZD5069 (DRUG), tremelimumab (treme) (DRUG).
Who is sponsoring clinical trial NCT02499328?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02499328's enrollment target sits among peer trials
340 104th of 2000 higher than 1,895 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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