Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-03-06 @ 6:23 PM
Study NCT ID:
NCT02316834
Status:
COMPLETED
Last Update Posted:
2022-02-24
First Post:
2014-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Talazoparib in Determining Genetic Effects on Disease Response in Patients With Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
POSITION: A Pilot Study of Induction PARP Inhibition in Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POSITION
Brief 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.
Detailed Description:
PRIMARY OBJECTIVES:
I. To explore basal levels and effects of talazoparib (BMN 673) on DNA copy number, loss of heterozygosity and mutation, and level of ribonucleic acid (RNA) and protein expression (together described as "molecular results") in homologous recombination-related pathways before and after treatment in women with primary advanced high grade serous ovarian, fallopian tube, or primary peritoneal cancer.
SECONDARY OBJECTIVES:
I. To correlate molecular results to clinical endpoints including response and survival.
II. To correlate molecular results to pathologic endpoints including tumor volume and apoptosis.
III. To compare DNA copy number and level of RNA and protein expression in homologous recombination-related pathways in tissue from patients treated with BMN 673 to those untreated with BMN 673 in the preoperative period.
IV. To determine the toxicity of daily BMN 673 given preoperatively, with a focus on postoperative wound healing.
V. To determine feasibility of daily BMN 673 given preoperatively.
OUTLINE:
Patients receive talazoparib orally (PO) once daily (QD) for up to 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 3 months thereafter.
I. To explore basal levels and effects of talazoparib (BMN 673) on DNA copy number, loss of heterozygosity and mutation, and level of ribonucleic acid (RNA) and protein expression (together described as "molecular results") in homologous recombination-related pathways before and after treatment in women with primary advanced high grade serous ovarian, fallopian tube, or primary peritoneal cancer.
SECONDARY OBJECTIVES:
I. To correlate molecular results to clinical endpoints including response and survival.
II. To correlate molecular results to pathologic endpoints including tumor volume and apoptosis.
III. To compare DNA copy number and level of RNA and protein expression in homologous recombination-related pathways in tissue from patients treated with BMN 673 to those untreated with BMN 673 in the preoperative period.
IV. To determine the toxicity of daily BMN 673 given preoperatively, with a focus on postoperative wound healing.
V. To determine feasibility of daily BMN 673 given preoperatively.
OUTLINE:
Patients receive talazoparib orally (PO) once daily (QD) for up to 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 3 months thereafter.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2014-02608 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 2014-0474 | OTHER | M D Anderson Cancer Center | View | |
| P30CA016672 | NIH | None | https://reporter.nih.gov/quic… | View |
| P50CA083639 | NIH | None | https://reporter.nih.gov/quic… | View |