NCT02316834: POSITION

Talazoparib in Determining Genetic Effects on Disease Response in Patients With Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Completed EARLY_PHASE1 Last updated 24 February 2022

What this trial tests

EARLY_PHASE1 trial testing Laboratory Biomarker Analysis in Fallopian Tube Serous Adenocarcinoma in 4 participants. Completed in 14 January 2022.

Timeline

2 June 2015

Primary endpoint
14 January 2022

14 January 2022

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	2 June 2015
Primary completion	14 January 2022
Estimated completion	14 January 2022
Sites	6 locations across United States

Drugs / interventions tested

• Laboratory Biomarker Analysis — full drug profile →
• BMN 673 — full drug profile →

Conditions studied

• Fallopian Tube Serous Adenocarcinoma — all drugs for Fallopian Tube Serous Adenocarcinoma →
• High Grade Ovarian Serous Adenocarcinoma — all drugs for High Grade Ovarian Serous Adenocarcinoma →
• Ovarian Mass — all drugs for Ovarian Mass →
• Primary Peritoneal Serous Adenocarcinoma — all drugs for Primary Peritoneal Serous Adenocarcinoma →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, female only, with Fallopian Tube Serous Adenocarcinoma or High Grade Ovarian Serous Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Poly (ADP-Ribose) Polymerase Inhibitors: Talazoparib in Ovarian Cancer and Beyond.
   Boussios S, Abson C, Moschetta M, Rassy E, et al · · 2020 · cited 113× · PMID 32215876 · DOI 10.1007/s40268-020-00301-8
2. Current status and future prospects of PARP inhibitor clinical trials in ovarian cancer.
   Jiang X, Li W, Li X, Bai H, et al · · 2019 · cited 75× · PMID 31191001 · DOI 10.2147/cmar.s200524
3. PARP Inhibitors in Ovarian Cancer: The Route to "Ithaca".
   Boussios S, Karathanasi A, Cooke D, Neille C, et al · · 2019 · cited 63× · PMID 31109041 · DOI 10.3390/diagnostics9020055
4. Evaluation of rucaparib and companion diagnostics in the PARP inhibitor landscape for recurrent ovarian cancer therapy.
   Jenner ZB, Sood AK, Coleman RL. · · 2016 · cited 60× · PMID 27087632 · DOI 10.2217/fon-2016-0002
5. PARP Inhibitors in Reproductive System Cancers: Current Use and Developments.
   O'Sullivan Coyne G, Chen AP, Meehan R, Doroshow JH. · · 2017 · cited 37× · PMID 28078645 · DOI 10.1007/s40265-016-0688-7
6. Systems approach to rational combination therapy: PARP inhibitors.
   Sun C, Fang Y, Labrie M, Li X, et al · · 2020 · cited 34× · PMID 32379297 · DOI 10.1042/bst20191092
7. Multiomics analysis of serial PARP inhibitor treated metastatic TNBC inform on rational combination therapies.
   Labrie M, Li A, Creason A, Betts C, et al · · 2021 · cited 22× · PMID 34667258 · DOI 10.1038/s41698-021-00232-w
8. Adaptive responses in a PARP inhibitor window of opportunity trial illustrate limited functional interlesional heterogeneity and potential combination therapy options.
   Labrie M, Kim TB, Ju Z, Lee S, et al · · 2019 · cited 22× · PMID 31191824 · DOI 10.18632/oncotarget.26947