Condition
Estrogen Receptor Negative|Head and Neck Squamous Cell Carcinoma|HER2/Neu Negative|Hormone-Resistant Prostate Cancer|Metastatic Pancreatic Adenocarcinoma|Progesterone Receptor Negative|Solid Neoplasm|Stage III Mesothelioma|Stage IIIA Gastric Cancer|Stage IIIA Non-Small Cell Lung Cancer|Stage IIIA Ovarian Cancer|Stage IIIA Small Cell Lung Carcinoma|Stage IIIB Gastric Cancer|Stage IIIB Non-Small Cell Lung Cancer|Stage IIIB Ovarian Cancer|Stage IIIB Small Cell Lung Carcinoma|Stage IIIC Gastric Cancer|Stage IIIC Ovarian Cancer|Stage IV Mesothelioma|Stage IV Non-Small Cell Lung Cancer|Stage IV Ovarian Cancer|Stage IV Small Cell Lung Carcinoma|Triple-Negative Breast Carcinoma
Estimated Enrollment: 0
Age Group: 18 Years and older (Adult, Senior)
Gender: All
Study Type: Interventional
Study Design Allocation: Intervention Model: Single Group Assignment|Masking: No masking|Primary Purpose: Treatment
Study ID Numbers: NCI-2015-01641|PJC-022|9942|UM1CA186644
Study First Received: October 2, 2015
Last Updated: April 14, 2017
Estimated Primary Completion Date: October 2018
Primary Outcome Measures:
Incidence of toxicity, graded according to the National Cancer Institute (NCI) CTCAE version 4.03|Recommended phase 2 dose of talazoparib, graded according to NCI CTCAE version 4.0|Tolerability of talazoparib in patients with varying degrees of hepatic and renal dysfunction|Biomarkers associated with response or resistance to talazoparib|Objective response, graded according to RECIST version 1.1|PK profiles of talazoparib in patients with varying degrees of hepatic and renal dysfunction|Progression-free survival (PFS)|Response rate
Sponsors and Collaborators:
National Cancer Institute (NCI)
Website Link: https://ClinicalTrials.gov/show/NCT02567396
