Spots Global Cancer Trial Database for Safety and Effectiveness Study of CPI-613 and/or Gemcitabine to Treat Metastatic Pancreatic Cancer

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Trial Identification

Brief Title: Safety and Effectiveness Study of CPI-613 and/or Gemcitabine to Treat Metastatic Pancreatic Cancer

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

Study ID: NCT01830322

Conditions

Metastatic Pancreatic Adenocarcinoma

Interventions

CPI-613

Gemcitabine

Any non-gemcitabine chemotherapies or best supportive care

Study Description

Brief Summary: 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.

Detailed Description: 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