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NCT03968406 · ClinicalTrials.gov registry record · Phase 1
Talazoparib and Radiation Therapy in Treating Patients With Locally Recurrent Gynecologic Cancers
A Phase 1 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 2
- Study locations
NCT03968406: Recruiting Phase 1 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma, sponsored by M.D. Anderson Cancer Center.
NCT03968406 is a Phase 1 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 24 participants, below the 124-participant average among 39 other Recurrent Ovarian Carcinoma trials with a reported enrollment target (81% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03968406, a Phase 1 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of talazoparib in combination with radiation therapy and to see how well they work in treating patients with gynecologic cancers that have come back after previous treatment (recurrent). Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving talazoparib in combination with radiation therapy may work better in treating patients with gynecologic cancers.
Primary Outcome
MTD is determined by dose limiting toxicity (DLT). The MTD will be determine using the time-to-event Bayesian optimal interval (TITE-BOIN) model, and it is defined as the dose for which the isotonic estimate of the DLT rate is closest to the target DLT rate.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- RADIATION Radiation Therapy
- DRUG Talazoparib
Study Locations (2)
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2019-09-26 |
| Est. Completion | 2027-10-01 |
| Phase | Phase 1 |
What NCT03968406 shows while recruiting
NCT03968406 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 124-participant average among 39 other Recurrent Ovarian Carcinoma trials with a reported enrollment target (81% lower).
The record links to 10 conditions, with Recurrent Ovarian Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Quality-of-Life Assessment is the first listed.
NCT03968406 reports a single indexed study location in Maryland, Texas.
Frequently Asked Questions
What is clinical trial NCT03968406 about?
NCT03968406 is a clinical study titled "Talazoparib and Radiation Therapy in Treating Patients With Locally Recurrent Gynecologic Cancers". This phase I trial studies the side effects and best dose of talazoparib in combination with radiation therapy and to see how well they work in treating patients with gynecologic cancers that have come back after previous treatment (recurrent). Talazoparib may stop the growth of tumor cells by block...
What is the current status of trial NCT03968406?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2019-09-26. Estimated completion is 2027-10-01.
What conditions does trial NCT03968406 study?
This clinical trial studies the following conditions: Recurrent Ovarian Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Primary Peritoneal Carcinoma, Recurrent Endometrial Carcinoma, Malignant Female Reproductive System Neoplasm.
What interventions are being tested in trial NCT03968406?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Radiation Therapy (RADIATION), Talazoparib (DRUG).
Who is sponsoring clinical trial NCT03968406?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03968406 being conducted?
This trial has 2 study locations across Maryland, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Ovarian Carcinoma
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 NCT03968406's enrollment target sits among peer trials
24 32nd of 39 higher than 8 of 39 other Recurrent Ovarian Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Ovarian Carcinoma 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.
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