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NCT01585805 · ClinicalTrials.gov registry record · Phase 2
Gemcitabine Hydrochloride and Cisplatin With or Without Veliparib or Veliparib Alone in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
A Phase 2 study of Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 88
- Enrollment target
- 12
- Study locations
NCT01585805: Active Phase 2 study of Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
NCT01585805 is a Phase 2 study of Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 88 participants, roughly in line with the 88-participant average among 37 other Metastatic Pancreatic Adenocarcinoma trials with a reported enrollment target. The trial reports 12 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01585805, a Phase 2 study of Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 88 participants
- Enrollment target
- 12
- Study locations
Study Summary
This randomized phase II trial studies how well veliparib together with gemcitabine hydrochloride and cisplatin works compared to gemcitabine hydrochloride and cisplatin alone in treating patients with pancreatic cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or spread from the primary site (place where it started) to other places in the body (metastatic). Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving veliparib together with gemcitabine hydrochloride and cisplatin is an effective treatment for pancreatic cancer.
Primary Outcome
There will be a small lead-in, non-randomized portion to Part I, where dose levels of veliparib 20 mg po BID (dose level 0), 40 mg po BID (dose level 1) and 80 mg po BID (dose level 2), will be evaluated on a day 1-12 schedule. The doses of gemcitabine 600 mg/m2 and cisplatin 25 mg/m2 are fixed. Three-6 patients will be evaluated per dose level starting with 20 mg po BID (dose level 0). If no dose-limiting toxicity (DLT), the dose of veliparib will be increased to 40 mg po BID (dose level 1) and
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Cisplatin
- PROCEDURE Biopsy
- DRUG Gemcitabine
Study Locations (12)
New York
- Memorial Sloan Kettering Commack - Commack
- Memorial Sloan Kettering Westchester - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau - Uniondale
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
- Ingalls Memorial Hospital - Harvey
Other
- Shaare Zedek Medical Center - Jerusalem
- Chaim Sheba Medical Center - Tel Litwinsky
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
Missouri
- Mercy Hospital Saint Louis - St Louis
New Jersey
- Memorial Sloan Kettering Basking Ridge - Basking Ridge
Ontario
- University Health Network-Princess Margaret Hospital - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2012-05-15 |
| Est. Completion | 2026-03-06 |
| Phase | Phase 2 |
What the registry record for NCT01585805 still lists
NCT01585805 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, roughly in line with the 88-participant average among 37 other Metastatic Pancreatic Adenocarcinoma trials with a reported enrollment target.
The record links to 4 conditions, with Metastatic Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT01585805 lists 12 locations in 7 states (New York, Illinois, Other).
Frequently Asked Questions
What is clinical trial NCT01585805 about?
NCT01585805 is a clinical study titled "Gemcitabine Hydrochloride and Cisplatin With or Without Veliparib or Veliparib Alone in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer". This randomized phase II trial studies how well veliparib together with gemcitabine hydrochloride and cisplatin works compared to gemcitabine hydrochloride and cisplatin alone in treating patients with pancreatic cancer that has spread from where it started to nearby tissue or lymph nodes (locally a...
What is the current status of trial NCT01585805?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2012-05-15. Estimated completion is 2026-03-06.
What conditions does trial NCT01585805 study?
This clinical trial studies the following conditions: Metastatic Pancreatic Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Locally Advanced Pancreatic Adenocarcinoma.
What interventions are being tested in trial NCT01585805?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Cisplatin (DRUG), Biopsy (PROCEDURE), Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT01585805?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01585805 being conducted?
This trial has 12 study locations across Illinois, Michigan, Missouri, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01585805's enrollment target sits among peer trials
88 9th of 37 higher than 28 of 37 other Metastatic Pancreatic Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Pancreatic Adenocarcinoma 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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