Status:
WITHDRAWN
Safety and Effectiveness Study of CPI-613 and/or Gemcitabine to Treat Metastatic Pancreatic Cancer
Lead Sponsor:
Cornerstone Pharmaceuticals
Conditions:
Metastatic Pancreatic Adenocarcinoma
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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...
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 cond...
Eligibility Criteria
Inclusion
- Histologically and cytologically confirmed, measurable metastatic pancreatic adenocarcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status being 0-2
- Expected survival \>2 months
- 18 years of age or older of both genders
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device \[IUD\], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation. (Note: Pregnant patients are excluded because the effects of CPI-613 on a fetus are unknown.)
- Fertile men must practice effective contraceptive methods during the study, unless documentation of infertility exists.
- At least 2 weeks must have elapsed from any prior surgery or hormonal therapy. Must have fully recovered from the acute toxicities of any prior treatment with any anti-cancer drugs, radiotherapy or other anti-cancer modalities (returned to baseline status as noted before most recent treatment). Patients with persisting, stable chronic toxicities from prior treatment ≤Grade 1 are eligible, but must be documented as such.
- Laboratory values ≤2 weeks must be:
- Adequate hematologic (white blood cell \[WBC\] ≥3500 cells/mm3 or ≥3.5 bil/L; platelet count ≥150,000 cells/mm3 or ≥150 bil/L; absolute neutrophil count \[ANC\] ≥1500 cells/mm3 or ≥1.5 bil/L; and hemoglobin (Hgb) ≥9 g/dL or ≥90 g/L).
- Adequate hepatic function (aspartate aminotransferase \[AST/SGOT\] ≤3x upper normal limit \[UNL\], alanine aminotransferase \[ALT/SGPT\] ≤3x UNL (≤5x UNL if liver metastases present), bilirubin ≤1.5x UNL).
- Adequate renal function (serum creatinine ≤2.0 mg/dL or 177 μmol/L, and blood urea nitrogen \[BUN\] ≤25 mg/dL).
- Adequate coagulation ("International Normalized Ratio or INR must be \<1.5"), unless treated with anticoagulants.
- No evidence of active infection and no serious infection within the past month; no systemic fungal, bacterial, viral or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment.
- Consent to participating the study by signed informed consent form
Exclusion
- Serious medical illness that would potentially increase patients' risk for toxicity
- Any active uncontrolled bleeding or patients with a bleeding diathesis (e.g., active peptic ulcer disease)
- Patients with active central nervous system (CNS) or epidural tumor
- Lactating females (Note: Lactating females are excluded because the effects of CPI-613 on a nursing child are unknown)
- Life expectancy less than 2 months
- Unwilling or unable to follow protocol requirements
- Dyspnea with minimal to moderate exertion, or patients with pleural, pericardial, or peritoneal effusions
- Active heart disease including but not limited to symptomatic congestive heart failure, symptomatic coronary artery disease, symptomatic angina pectoris, symptomatic myocardial infarction, arrhythmias requiring medication, or symptomatic congestive heart failure. Also patients with a history of myocardial infarction that is \<1 year prior to registration, or patients with previous congestive heart failure (\<1 year prior to registration) requiring pharmacologic support or with Left Ventricular Ejection Fraction \<50%).
- A marked baseline prolongation of QT/QTc interval (e.g., repeated exhibition of a QTc interval \>470 ms.); a history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
- Requirement for immediate palliative treatment of any kind including surgery
- Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01830322
Start Date
January 1 2014
End Date
December 1 2018
Last Update
August 14 2013
Active Locations (2)
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1
Eastchester Center for Cancer Care
The Bronx, New York, United States, 10469
2
Temple Vasicek Cancer Treatment Center
Temple, Texas, United States, 76508