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ACTIVE NOT RECRUITING Phase 2

Gemcitabine Hydrochloride and Cisplatin With or Without Veliparib or Veliparib Alone in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

NCT01585805 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 88 participants
Start Date 2012-05-15
Est. Completion 2026-03-06
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01585805

The ClinicalTrials.gov registry entry for NCT01585805 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01585805 reports 12 study locations spanning 7 distinct geographic areas — top geographies include New York, Illinois, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01585805?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial