Study to Provide Continued Access to Napabucasin for Patients Enrolled in Sumitomo Dainippon Pharma Oncology, Inc. sponsored Napabucasin Protocols
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ABSTRACT: Primary objectives: To evaluate the long-term safety and tolerability of napabucasin through the evaluation of AEs, clinically significant physical examination findings, and clinically relevant laboratory results.
Primary endpoints: 1. Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE versión 4.0), seriousness, and relationship to study therapy.2. Laboratory abnormalities as characterized by type, frequency, and severity (as graded by NCIC version 4.0).3. Vital signs.4. Physical examination.5. ECG.
DISEASE(S): Metastatic Pancreatic Adenocarcinoma And Metastatic Colorectal Cancer.
PROVIDER: 2555772 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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