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NCT02583477 · ClinicalTrials.gov registry record · Phase 1
Phase Ib/II Study of MEDI4736 Evaluated in Different Combinations in Metastatic Pancreatic Ductal Carcinoma
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT02583477: Completed Phase 1 study, sponsored by AstraZeneca.
NCT02583477 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02583477, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
A Phase Ib and II Open-Label, Multi-Center Study of MEDI4736 Evaluated in Different Combinations (with chemotherapy or AZD5069) in Patients with Metastatic Pancreatic Ductal Adenocarcinoma
Primary Outcome
DLT period was defined as first treatment cycle for Cohort 1, and first dose of AZD5069 and MEDI4736 to end of Cycle 1 or until a participant experienced a DLT, whichever occurs first for Cohort 2. A DLT was defined as any of below listed laboratory abnormalities or adverse events (AE) related to MEDI4736 collected during DLT period. * Liver transaminase elevation \>= 5× but \<= 8× upper limit of normal (ULN) that doesn't resolve to Grade 2 within 5 days * Transaminase elevation \> 8× ULN or t
Interventions
- DRUG MEDI4736 in combination with nab-paclitaxel and gemcitabine
- DRUG MEDI4736 in combination with AZD5069
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2016-03-25 |
| Est. Completion | 2018-07-09 |
| Phase | Phase 1 |
What the finished NCT02583477 record still lists
NCT02583477 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which MEDI4736 in combination with nab-paclitaxel and gemcitabine is the first listed.
NCT02583477 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02583477 about?
NCT02583477 is a clinical study titled "Phase Ib/II Study of MEDI4736 Evaluated in Different Combinations in Metastatic Pancreatic Ductal Carcinoma". A Phase Ib and II Open-Label, Multi-Center Study of MEDI4736 Evaluated in Different Combinations (with chemotherapy or AZD5069) in Patients with Metastatic Pancreatic Ductal Adenocarcinoma
What is the current status of trial NCT02583477?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2016-03-25. Estimated completion is 2018-07-09.
What interventions are being tested in trial NCT02583477?
The interventions under investigation include: MEDI4736 in combination with nab-paclitaxel and gemcitabine (DRUG), MEDI4736 in combination with AZD5069 (DRUG).
Who is sponsoring clinical trial NCT02583477?
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 NCT02583477's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 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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