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PARP Inhibitor

Talazoparib Oral Capsule for Ovarian Cancer

Phase 1
Waitlist Available
Led By Don S Dizon, MD
Research Sponsored by Don Dizon
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first 2 years of study.
Awards & highlights

Study Summary

This trial is studying how well niraparib works in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back or spread to other parts of the body and who have a BRCA1 or BRCA2 gene mutation.

Eligible Conditions
  • Ovarian Cancer
  • BRCA1
  • BRCA2 Mutation
  • Serous Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first 2 years of study.
This trial's timeline: 3 weeks for screening, Varies for treatment, and first 2 years of study. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the Preliminary Effectiveness of Talazorparib
Secondary outcome measures
Feasibility of the Trial Design.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Planned TherapyExperimental Treatment1 Intervention
Talazoparib monotherapy as 1 mg capsule orally on a daily basis for three cycles, defined as a 21-day period, prior to surgery. Volunteers will continue treatment to complete three cycles, unless disease progression or unacceptable toxicity occurs.Volunteers who complete neoadjuvant treatment with talazoparib should undergo surgical cytoreduction within three weeks of their last dose of talazoparib. All volunteers should then undergo standard of care adjuvant therapy using carboplatin and paclitaxel. For volunteers, who agree to continue talazoparib as maintenance therapy, treatment should begin three weeks (+/- 2 weeks) from the end of adjuvant chemotherapy or after cytoreductive surgery alone.

Find a Location

Who is running the clinical trial?

Don DizonLead Sponsor
2 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Ovarian Cancer
46 Patients Enrolled for Ovarian Cancer
Brown UniversityLead Sponsor
456 Previous Clinical Trials
563,080 Total Patients Enrolled
1 Trials studying Ovarian Cancer
46 Patients Enrolled for Ovarian Cancer
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,873 Total Patients Enrolled
20 Trials studying Ovarian Cancer
2,785 Patients Enrolled for Ovarian Cancer

Media Library

Talazoparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04598321 — Phase 1
Ovarian Cancer Research Study Groups: Planned Therapy
Ovarian Cancer Clinical Trial 2023: Talazoparib Highlights & Side Effects. Trial Name: NCT04598321 — Phase 1
Talazoparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04598321 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies available in this trial for people to join?

"Clinicaltrials.gov reports that this medical study is currently enrolling patients, with the original posting having been made on March 29th 2021 and last edited on July 19th 2022."

Answered by AI

How many individuals have been invited to participate in this clinical experiment?

"Indeed, the information hosted on clinicaltrials.gov affirms this medical study is currently searching for participants. This trial was first posted on March 29th 2021 and has been modified as recently as July 19th 2022. The research team needs to recruit 30 patients from two different sites."

Answered by AI

What impact has Talazoparib Oral Capsule had on human health?

"Given the limited data on efficacy and safety, our team assigned Talazoparib Oral Capsule a score of 1."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Rhode Island Hospital
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Average response time
  • < 1 Day
Typically responds via
Phone Call
Most responsive sites:
  1. Rhode Island Hospital: < 24 hours
Recent research and studies
clinicaltrials.govStudy
BrUOG 390: Neoadjuvant Treatment With Talazoparib
Don Dizon 2021. "BrUOG 390: Neoadjuvant Treatment With Talazoparib". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04598321.
~0 spots leftby Apr 2025
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