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NCT02326844 · ClinicalTrials.gov registry record · Phase 2
BMN 673 (Talazoparib), an Oral PARP Inhibitor, in People With Deleterious BRCA1/2 Mutation-Associated Ovarian Cancer Who Have Had Prior PARP Inhibitor Treatment
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT02326844: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT02326844 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 3 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02326844, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study 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.
Interventions
- DRUG BMN 673 (talazoparib)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2015-03-02 |
| Est. Completion | 2016-04-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02326844
The ClinicalTrials.gov registry entry for NCT02326844 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which BMN 673 (talazoparib) is the first listed.
NCT02326844 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02326844 about?
NCT02326844 is a clinical study titled "BMN 673 (Talazoparib), an Oral PARP Inhibitor, in People With Deleterious BRCA1/2 Mutation-Associated Ovarian Cancer Who Have Had Prior PARP Inhibitor Treatment". 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 ...
What is the current status of trial NCT02326844?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2015-03-02. Estimated completion is 2016-04-14.
What interventions are being tested in trial NCT02326844?
The interventions under investigation include: BMN 673 (talazoparib) (DRUG).
Who is sponsoring clinical trial NCT02326844?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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