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NCT02316834 · ClinicalTrials.gov registry record · Early Phase 1

Talazoparib in Determining Genetic Effects on Disease Response in Patients With Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

A Early Phase 1 study of Fallopian Tube Serous Adenocarcinoma and High Grade Ovarian Serous Adenocarcinoma, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Early Phase 1
Development phase
4
Enrollment target
6
Study locations

NCT02316834: Completed Early Phase 1 study of Fallopian Tube Serous Adenocarcinoma and High Grade Ovarian Serous Adenocarcinoma, sponsored by M.D. Anderson Cancer Center.

NCT02316834 is a Early Phase 1 study of Fallopian Tube Serous Adenocarcinoma and High Grade Ovarian Serous Adenocarcinoma that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 4 participants, below the 541-participant average among 8 other Fallopian Tube Serous Adenocarcinoma trials with a reported enrollment target (99% lower). The trial reports 6 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02316834, a Early Phase 1 study of Fallopian Tube Serous Adenocarcinoma and High Grade Ovarian Serous Adenocarcinoma, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Early Phase 1
Development phase
4 participants
Enrollment target
6
Study locations

Study Summary

This pilot early phase I trial studies talazoparib to determine if certain characteristics of the deoxyribonucleic acid (DNA) affect how the disease responds to therapy in patients with ovarian, fallopian tube, or primary peritoneal cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Studying samples of tissue in the laboratory from patients receiving talazoparib may help doctors learn more about the effects of talazoparib on cells and may help doctors understand how well patients respond to treatment.

Primary Outcome

Will use descriptive statistics and graphical methods to summarize the change in DNA copy number. Will summarize these changes for untreated patients. Will use a paired t-test to test that mean changes are different from 0. Will test median changes with a Wilcoxon signed-rank test. Will use a 2-sample t-test to compare mean changes between treated and untreated patients. Will compare median changes between treated and untreated patients with a Wilcoxon rank sum test.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG BMN 673

Study Locations (6)

Texas

  • M D Anderson Cancer Center - Houston
  • The Woman's Hospital of Texas - Houston
  • MD Anderson Regional Care Center-Katy - Houston
  • MD Anderson Regional Care Center-Bay Area - Nassau Bay
  • MD Anderson Regional Care Center-Sugar Land - Sugar Land
  • MD Anderson Regional Care Center-The Woodlands - The Woodlands

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2015-06-02
Est. Completion 2022-01-14
Phase Early Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT02316834 record still lists

NCT02316834 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 541-participant average among 8 other Fallopian Tube Serous Adenocarcinoma trials with a reported enrollment target (99% lower).

The record links to 10 conditions, with Fallopian Tube Serous Adenocarcinoma appearing as the primary indexed condition, and to 2 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT02316834 lists 6 locations in 1 state (Texas).

Frequently Asked Questions

What is clinical trial NCT02316834 about?

NCT02316834 is a clinical study titled "Talazoparib in Determining Genetic Effects on Disease Response in Patients With Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer". This pilot early phase I trial studies talazoparib to determine if certain characteristics of the deoxyribonucleic acid (DNA) affect how the disease responds to therapy in patients with ovarian, fallopian tube, or primary peritoneal cancer that has spread to other places in the body and usually cann...

What is the current status of trial NCT02316834?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 4 participants. The study started on 2015-06-02. Estimated completion is 2022-01-14.

What conditions does trial NCT02316834 study?

This clinical trial studies the following conditions: Fallopian Tube Serous Adenocarcinoma, High Grade Ovarian Serous Adenocarcinoma, Primary Peritoneal Serous Adenocarcinoma, Stage III Fallopian Tube Cancer AJCC v7, Stage III Ovarian Cancer AJCC v6 and v7.

What interventions are being tested in trial NCT02316834?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), BMN 673 (DRUG).

Who is sponsoring clinical trial NCT02316834?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02316834 being conducted?

This trial has 6 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Fallopian Tube Serous Adenocarcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02316834's enrollment target sits among peer trials

4 9th of 8 the lowest of 8 other Fallopian Tube Serous Adenocarcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Fallopian Tube Serous 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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Source: ClinicalTrials.gov NCT02316834, the US trial registry maintained by the National Library of Medicine. NCT02316834 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.