Clinical trial · Interventional
Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors
A Phase 1, First In Human, Single-arm, Open-label Study Of Once A Day, Orally Administered Talazoparib (Bmn 673) In Patients With Advanced Or Recurrent Solid Tumors
NCT01286987CI-TRIAL-00036457completedPhase 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 is a single-arm, open-label study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of talazoparib in patients with advanced tumors with DNA-repair pathway deficiencies. There will be 2 parts to the study: a dose escalation phase in which the maximum tolerated dose will be defined, and a dose expansion phase.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced or Recurrent Solid Tumors | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Ewing Sarcoma | Ewing Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Cancer, Epithelial | Ovarian Carcinoma | ALIAS | 0.90 |
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Small Cell Lung Carcinoma | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Talazoparib | Drug | Talazoparib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Talazoparib
- interventionNames
- Drug: Talazoparib
Primary outcomes (7)
- measure
- Number of Participants With Objective Response
- timeFrame
- From Baseline until disease progression or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)
- description
- Objective response in participants was defined as the number of participants with complete response (CR) or partial response (PR) after treatment with talazoparib and maintained for at least 4 weeks (28 days) as assessed by response evaluation criteria in solid tumors (RECIST) version 1.1. CR defined as disappearance of all non-nodal target lesions (where all target lesions were recorded with a length of 0 millimeter \[mm\] on the case report form \[CRF\]) and the reduction of the shortest diameter of all nodal lesions to less than \[\<\] 10 mm. PR was defined by a 30% or more decrease in the sum of the longest diameters (SLD) + sum of shortest diameters (SSD) of target lesions, taking as reference the baseline SLD+SSD.
- measure
- Number of Participants With Best Overall Response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically documented, unresectable, locally advanced or metastatic solid tumor * Must have available archived tumor tissue (formalin-fixed paraffin-embedded) \[FFPE\]. * 18 years of age or older. * Have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) or increased CA-125 (ovarian cancer) or PSA (prostate cancer) and/or CA 19-9 (pancreatic cancer). * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. * Have adequate organ function * Able to take oral medications. * Willing and able to provide informed consent. * Sexually active patients must be willing to use an acceptable method of contraception. * Females of childbearing potential must have a negative serum pregnancy test at screening. * Willing and able to comply with all study procedures. Part 2 Dose Expansion Tumor Types: * Breast and ovarian cancer patients with deleterious or pathogenic BRCA mutations who have received no more than 4 prior regimens for metastatic disease. * Prostate or pancreatic cancer patients with deleterious or pathogenic BRCA mutations who have received no more than 2 prior regimens for metastatic disease. * Small cell lung cancer (SCLC) patients who have received no more than one prior regimen for SCLC. * Ewing's sarcoma patients who have received no more than 3 prior regimens for metastatic disease. Exclusion Criteria: * Part 2 Expansion: Prior treatment with a PARP inhibitor. * Has history of central nervous system (CNS) metastasis. \* Exception: In patients with SCLC, history of adequately treated brain metastasis who do not require corticosteroids for management of CNS symptoms. * Has had major surgery within 28 days before Cycle 1, Day 1. * Has active peptic ulcer disease. * Active gastrointestinal tract disease with malabsorption syndrome. * Pregnant or breastfeeding at screening or planning to become pregnant (in each case, either oneself or one's partner) at any time during the study.
References
Publications (0)
Data not yet available
No reference posted for this study.