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NCT01749397 · ClinicalTrials.gov registry record · Phase 1

Veliparib and Floxuridine in Treating Patients With Metastatic Epithelial Ovarian, Primary Peritoneal Cavity, or Fallopian Tube Cancer

A Phase 1 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
29
Enrollment target

NCT01749397: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT01749397 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01749397, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
29 participants
Enrollment target

Study Summary

This phase I trial studies the side effects and best dose of veliparib when given together with floxuridine in treating patients with epithelial ovarian, primary peritoneal cavity, or fallopian tube cancer that has spread to other places in the body. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as floxuridine, 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. Giving veliparib together with floxuridine may kill more tumor cells.

Primary Outcome

The number and severity of all adverse events (overall, by dose-level, and by tumor group) will be tabulated and summarized in this patient population. The grade 3+ adverse events will also be described and summarized in a similar fashion. This will provide an indication of the level of tolerance for this treatment combination in this patient group.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Floxuridine
  • OTHER Pharmacological Study
  • DRUG Veliparib

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2012-12-07
Est. Completion 2019-11-21
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT01749397 record still lists

NCT01749397 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).

The record links to 0 conditions, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT01749397 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01749397 about?

NCT01749397 is a clinical study titled "Veliparib and Floxuridine in Treating Patients With Metastatic Epithelial Ovarian, Primary Peritoneal Cavity, or Fallopian Tube Cancer". This phase I trial studies the side effects and best dose of veliparib when given together with floxuridine in treating patients with epithelial ovarian, primary peritoneal cavity, or fallopian tube cancer that has spread to other places in the body. Veliparib may stop the growth of tumor cells by b...

What is the current status of trial NCT01749397?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2012-12-07. Estimated completion is 2019-11-21.

What interventions are being tested in trial NCT01749397?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Floxuridine (DRUG), Pharmacological Study (OTHER), Veliparib (DRUG).

Who is sponsoring clinical trial NCT01749397?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01749397's enrollment target sits among peer trials

29 1440th of 2000 higher than 554 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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Source: ClinicalTrials.gov NCT01749397, the US trial registry maintained by the National Library of Medicine. NCT01749397 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.