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BMN 673 (Talazoparib), an Oral PARP Inhibitor, in People With Deleterious BRCA1/2 Mutation-Associated Ovarian Cancer Who Have Had Prior PARP Inhibitor Treatment

NCT02326844 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2020-08-18

Study results available
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Summary

Background:

\- The new drug BMN 673 (talazoparib) has been shown to fight tumor cells in animals and some people. It is a poly (ADP-ribose) polymerase (PARP) inhibitor. It works on tumor cell deoxyribonucleic acid (DNA) damage repair process. Researchers want to see if BMN 673 shrinks cancer again in women with ovarian cancer and whose cancer initially got shrunk but grew back on the first PARP inhibitor.

Objective:

\- To study BMN 673 (talazoparib) in people with ovarian cancer born with a breast cancer (BRCA) mutation and whose cancer got shrunk but became worse after they took a similar drug.

Eligibility:

* Women at least 18 years old:
* with recurrent and/or metastatic germline breast cancer mutation (gBRCAm)-associated ovarian cancer AND
* whose disease is growing after already being treated with PARP inhibitors AND
* with no other treatment(s) in between the first PARP inhibitors and a screening visit.

Design:

* Participants will be screened with medical history, physical exam, and heart and blood tests.
* Participants will take the study drug by mouth once daily. They will take the drug in 28-day cycles.
* They will keep a diary of doses and any side effects.
* Participants will have 4 study visits in cycle 1, then 1 visit every cycle. Visits may include:
* Blood tests
* Physical exam
* Computed tomography (CT) or magnetic resonance imaging (MRI) scans. Participants will lie in a machine that takes pictures of their body.
* Ultrasound
* Participants will have a biopsy before starting the study drug. A small piece of tumor tissue will be removed by needle, guided by a scan. They may have two more biopsies later.
* Participants will be followed for 30 days after taking the last dose of study drug. A physical exam, blood tests, and CT or other scans will be done.
* Participants will have follow-up calls to ask about any side effects.

Conditions

Interventions

DRUG

BMN 673 (talazoparib)

1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Jung-Min Lee, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-02
Primary Completion
2016-04-14
Completion
2016-04-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02326844 on ClinicalTrials.gov