Metastatic Pancreatic Adenocarcinoma Clinical Trial
Official title:
A Phase II Open-Label Clinical Trial of CPI-613 Given Alone, or in Combination With Gemcitabine, in Patients With Metastatic Pancreatic Cancer
This Phase II study is conducted to assess the safety and efficacy of CPI-613 in patients with metastatic pancreatic cancer. The primary outcome measure is Overall Survival (OS). The secondary outcome measures are: changes in CA 19-9, Quality of Life (QOL), Progression-Free Survival (PFS), and safety.
Data from dose-escalated Phase I trials indicate that CPI-613 is safe and effective against
metastatic pancreatic cancer (Lee et al. 2012; Retter et al. 2012). Accordingly, this Phase
II trial is conducted to assess the safety and efficacy of CPI-613 in patients with
metastatic pancreatic cancer.
Primary Outcome Measure:
- Overall Survival (OS)
Secondary Outcome Measures:
- Changes in CA 19-9
- Quality of Life (QOL) assessment
- Progression-Free Survival (PFS)
- Safety
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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