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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
CPI-613 drug product, provided in concentrated form at 50 mg/mL, must be diluted with D5W prior to administration. CPI-613 is to be infused intravenously (IV) via a central venous catheter. CPI-613 will be given 2x weekly, administered on Days 1 and 4 of each of the 3 treatment weeks, followed by a week of rest. The dose of CPI-613 will be 3,000 mg/m2 infused IV over 2 hours (this is approximate maximum tolerated dosing \[MTD\]), via a central venous catheter with D5W running at a rate of about 125-150 mL/hr.
Eastchester Center for Cancer Care
The Bronx, New York, United States
Temple Vasicek Cancer Treatment Center
Temple, Texas, United States
Overall Survival (OS)
Time frame: Monitored until participants pass away, for an expected average of 6 months.
Changes in CA 19-9
CA 19-9 is monitored through blood work ≤2 weeks before treatment and after every third cycle (12 weeks) of treatment while on-study. CA 19-9 is a pancreatic tumor biomarker and a decline in CA 19-9 during and after therapy may be a marker of treatment efficacy.
Time frame: Monitored within 2-weeks before treatment, and every 3-cycles (months) during treatment
Quality of Life (QOL)
QOL will be assessed as described by Aaronson NK, et al. 1993. It assesses how the various treatments and the disease affect the daily living abilities of the patient.
Time frame: Monitored before, during, and 1-week after treatment with CPI-613, for an expected average of 20 weeks.
Progression-Free Survival (PFS)
Time frame: Monitored during treatment with CPI-613 and until participants passed away, which will be an expected average of 6 months.
Safety
Safety assessment will be based on clinical signs, vital signs, blood work, adverse events (AEs), serious adverse events (SAEs), etc.
Time frame: Monitored just before study treatment, and during study treatment at the end of every 4-week treatment cycle, for an expected average of 20 weeks.
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