Clinical trial · Interventional
A Study to Assess the Effects of Talazoparib on Cardiac Repolarization in Patients With Advanced Solid Tumors
A PHASE 1, OPEN-LABEL STUDY TO ASSESS THE EFFECTS OF TALAZOPARIB ON CARDIAC REPOLARIZATION IN PATIENTS WITH ADVANCED SOLID TUMORS
NCT03042910CI-TRIAL-00042364completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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 study is designed to evaluate the effects of talazoparib on cardiac repolarization in patients with advanced solid tumors with no available standard treatment options.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Talazoparib | Drug | Talazoparib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with advanced solid tumors
- description
- Talazoparib 1 mg daily
- interventionNames
- Drug: Talazoparib
Primary outcomes (3)
- measure
- Time-matched Mean Change From Baseline in Corrected QT Intervals Based on the Fridericia's Correction Fomulation (QTcF)
- timeFrame
- Baseline (Day -1 time matched for each time point); 1, 2, 4 and 6 hours post-dose on Day 1; pre-dose on Day 2; pre-dose, 1, 2, 4 and 6 hours post-dose on Day 22
- description
- QT interval is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole.
- measure
- Intercept of Predicted Linear Mixed Effects Models for Change From Baseline in QTcF Versus Plasma Talazoparib Concentrations at Day 22
- timeFrame
- Baseline (Day -1) to Day 22
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. At least 18 years of age and willing and able to provide informed consent. 2. Histologically or cytologically confirmed advanced solid tumor with no available standard treatment options in the opinion of the investigator. 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. 4. Estimated life expectancy of ≥ 3 months. 5. Able to swallow the study drug, have no known intolerance to the study drug or excipients, and comply with study requirements. 6. Female patients of childbearing potential must have a negative pregnancy test at screening and must agree to use a highly effective birth control method from the time of the first dose of study drug through 45 days after last dose of study drug. 7. Male patients must use a condom when having sex with a pregnant woman or with a woman of childbearing potential from the time of the first dose of study drug through 105 days after last dose of study drug. Contraception should be considered for a nonpregnant female partner of childbearing potential. 8. Male and female patients must agree not to donate sperm or eggs, respectively, from the first dose of study drug through 105 days and 45 days after the last dose of study drug, respectively. 9. Female patients may not be breastfeeding at screening and must not breastfeed during study participation through 45 days after the last dose of study drug. Exclusion Criteria: 1. Use of antineoplastic therapies within 21 days before day 1. 2. Use of any other investigational agent within 21 days before day 1. 3. Have not recovered (recovery is defined as National Cancer Institute Common Terminology Criteria for Adverse Events \[CTCAE\] grade ≤ 1) from the acute toxicities of previous therapy, except treatment related alopecia or laboratory abnormalities otherwise meeting eligibility requirements. 4. Electrolyte abnormality that has not responded to correction, including hypokalemia or hypocalcemia less than the lower limit of normal, or hyperkalemia or hypercalcemia greater than the upper limit of normal (ULN). 5. Major surgery within 14 days before day 1. 6. Diagnosis of myelodysplastic syndrome (MDS) or a hematologic malignancy. 7. Clinically significant cardiovascular disease. 8. Significant organ dysfunction. 9. Gastrointestinal disorder affecting absorption. 10. Current or anticipated use of a strong P-gp inhibitor, strong P-gp inducer, or strong inhibitor of BCRP. 11. Any condition (concurrent disease, infection, or comorbidity) that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of safety data, in the opinion of the investigator or medical monitor.
References
Publications (0)
Data not yet available
No reference posted for this study.