Clinical trial · Interventional
Talazoparib in Determining Genetic Effects on Disease Response in Patients With Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
POSITION: A Pilot Study of Induction PARP Inhibition in Ovarian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (19)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Serous Adenocarcinoma | Fallopian Tube Serous Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| High Grade Ovarian Serous Adenocarcinoma | Ovarian High Grade Serous Adenocarcinoma | ALIAS | 0.90 |
| Ovarian Mass | — | UNRESOLVED | — |
| Primary Peritoneal Serous Adenocarcinoma | Primary Peritoneal Serous Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage IIIA Fallopian Tube Cancer AJCC v7 | Malignant Fallopian Tube Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Ovarian Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IIIA Primary Peritoneal Cancer AJCC v7 | — | UNRESOLVED |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMN 673 | Drug | Talazoparib | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BMN 673
- interventionNames
- Other: Laboratory Biomarker Analysis
- Drug: BMN 673
Primary outcomes (2)
- measure
- Change in deoxyribonucleic acid (DNA) copy number
- timeFrame
- Baseline to the day of tumor reductive surgery
- description
- Will use descriptive statistics and graphical methods to summarize the change in DNA copy number. Will summarize these changes for untreated patients. Will use a paired t-test to test that mean changes are different from 0. Will test median changes with a Wilcoxon signed-rank test. Will use a 2-sample t-test to compare mean changes between treated and untreated patients. Will compare median changes between treated and untreated patients with a Wilcoxon rank sum test.
- measure
- Change in ribonucleic acid (RNA) protein expression
- timeFrame
- Baseline to the day of tumor reductive surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with presumed advanced-stage high grade serous ovarian, fallopian tube, or primary peritoneal carcinoma, based on the presence of carcinomatosis, and/or elevated cancer antigen 125 (CA125), and/or ovarian mass(es), or at the discretion of the treating physician * Medically able to undergo primary cytoreductive surgery, at least 7 days and up to 28 days after starting study drug, as determined by treating physician * No prior therapy for high-grade serous ovarian, fallopian tube, or primary peritoneal carcinoma * Patients must be able to swallow and tolerate oral medications and not have gastrointestinal illnesses that would preclude absorption of BMN 673 (e.g. uncontrolled nausea, vomiting, or diarrhea; malabsorption syndrome; ulcerative disease) * Absolute neutrophil count \>= 1,500/mcL (measured within 28 days prior to entry/ randomization) * Hemoglobin \>= 9 gm/dL (measured within 28 days prior to entry/ randomization) * Platelets \>= 100,000/mcL (measured within 28 days prior to entry/ randomization) * Total bilirubin =\< 1.5 X upper limit of normal (ULN) (measured within 28 days prior to entry/ randomization) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal unless the liver is involved with tumor, in that case, ALT/AST must be =\< 5 x upper limit of normal (measured within 28 days prior to entry/ randomization) * Creatinine clearance \>= 50 mL/min (assessed by Cockcroft Gault estimation) (measured within 28 days prior to entry/ randomization) * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Women of child-bearing potential and their partners must agree to use contraception (hormonal or barrier method of birth control; abstinence) from the time of study entry until 30 days after the last dose of study medication; women of child-bearing potential (intact uterus) should have a negative serum pregnancy test; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; female patients must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening: * Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 consecutive months following cessation of all exogenous hormonal treatments * Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but not tubal ligation; male partners should be instructed to use contraception during the study period * Women must not breast-feed while taking the study medications * Patients must be able to understand and willing to sign an informed consent Exclusion Criteria: * Prior treatment for ovarian, fallopian tube, or primary peritoneal cancer * Receipt of any other investigational agents or any additional anti-cancer agents * Significant symptom burden from presumed diagnosis including large volume ascites, pain requiring narcotic medication, or shortness of breath on exertion * Myocardial infarction within 6 months before starting therapy, symptomatic congestive heart failure (New York Heart Association \> class II), unstable angina, or unstable cardiac arrhythmia requiring medication * As judged by the investigator, any evidence of severe or uncontrolled systemic diseases (e.g., severe hepatic impairment, interstitial lung disease \[bilateral, diffuse, parenchymal lung disease\], uncontrolled chronic renal diseases \[glomerulonephritis, nephritic syndrome, Fanconi syndrome or renal tubular acidosis\]), or current unstable or uncompensated respiratory or cardiac conditions, or uncontrolled hypertension (blood pressure \>= 140/90), active bleeding diatheses or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus; screening for chronic conditions is not required * As judged by the investigator, the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements
References
Publications (1)
- DERIVEDSun C, Fang Y, Labrie M, Li X, Mills GB. Systems approach to rational combination therapy: PARP inhibitors. Biochem Soc Trans. 2020 Jun 30;48(3):1101-1108. doi: 10.1042/BST20191092. PMID 32379297