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NCT01296763 · ClinicalTrials.gov registry record · Phase 1
Trial of ICM With or Without AZD2281 (Olaparib) in Patients With Advanced Pancreatic Cancer
A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01296763: Completed Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT01296763 is a Phase 1 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01296763, a Phase 1 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
Patients whose pancreatic cancers have defects in the BRCA/Fanconi DNA repair pathway or other defects in homologous repair will have cancers that respond to olaparib when given in combination with the DNA damaging agents, irinotecan, cisplatin, mitomycin C (ICM).
Primary Outcome
1.Phase I - Assess the safety and toxicities of IC with Olaparib escalating to ICM with Olaparib in patients with locally advanced and metastatic pancreatic cancer and determine the phase 2 dose. The number of subjects who experienced a dose limiting toxicity was assessed.Dose-limiting toxicity (DLT) is defined as any of the following study drug-related events experienced during Cycle 1: Thrombocytopenia with platelets \<25,000 x106/l \> 7 days. Grade 4 neutropenia lasting ≥7 days. Grade 3 or 4
Interventions
- DRUG Cisplatin
- DRUG Irinotecan
- DRUG Mitomycin-C
- DRUG Olaparib (for levels 1 and 5)
- DRUG Olaparib (for dose level 2)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-01 |
| Est. Completion | 2016-02 |
| Phase | Phase 1 |
What the finished NCT01296763 record still lists
NCT01296763 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 5 interventions - of which Cisplatin is the first listed.
NCT01296763 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01296763 about?
NCT01296763 is a clinical study titled "Trial of ICM With or Without AZD2281 (Olaparib) in Patients With Advanced Pancreatic Cancer". Patients whose pancreatic cancers have defects in the BRCA/Fanconi DNA repair pathway or other defects in homologous repair will have cancers that respond to olaparib when given in combination with the DNA damaging agents, irinotecan, cisplatin, mitomycin C (ICM).
What is the current status of trial NCT01296763?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2011-01. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01296763?
The interventions under investigation include: Cisplatin (DRUG), Irinotecan (DRUG), Mitomycin-C (DRUG), Olaparib (for levels 1 and 5) (DRUG), Olaparib (for dose level 2) (DRUG).
Who is sponsoring clinical trial NCT01296763?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01296763's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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