Status:
TERMINATED
Phase 2 Safety, Tolerability and Efficacy Study of CPI-613 in Cancer Patients
Lead Sponsor:
Cornerstone Pharmaceuticals
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This Phase II study is conducted to assess the safety and efficacy of CPI-613 in patients with advanced and/or metastatic solid tumors for whom there there is no available therapy to provide clinical ...
Detailed Description
Open-Label Single-Arm Design: This is an open-label study, and investigators and subjects are not blinded to the treatment. Also, the assignment of patients will not be randomized, since this is a sin...
Eligibility Criteria
Inclusion
- Patients must have advanced and/or metastatic, histologically or cytologically documented solid tumors, for whom there is no available therapy shown to provide clinical benefit or for those who have refused further standard therapy
- Eastern Cooperative Oncology Group (ECOG) performance status being 0-2
- Expected survival \>3 months
- 18 years of age or older of both genders
- Women of child-bearing potential 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.
- Fertile men must practice effective contraceptive methods during the study, unless documentation of infertility exists
- Mentally competent, with an ability to understand and willingness to sign the informed consent form
- No radiotherapy, treatment with cytotoxic agents (except CPI-613), or treatment with biologic agents within 3 weeks prior to treatment with CPI-613. At least 2 weeks must have elapsed from any prior surgery or hormonal therapy. Patients 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")
Exclusion
- Serious medical illness
- Any active uncontrolled bleeding or patients with a bleeding diathesis
- Patients with active central nervous system (CNS) or epidural tumor
- Pregnant women, or women of child-bearing potential not using reliable means of contraception
- Lactating females
- Fertile men unwilling to practice contraceptive methods during the study period
- Life expectancy less than 3 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.
- A marked baseline prolongation of QT/QTc interval; a history of additional risk factors for torsade de pointes.
- 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
- Albumin \<2.5 g/dL or \<25 g/L
- Evidence of active infection, or serious infection, with the past month
- Patients with known HIV infection.
- Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past 3 weeks prior to initiation of CPI-613 treatment.
- Patients who have received immunotherapy of any type within the past 4 weeks prior to initiation of CPI-613 treatment
- Patients that have received a chemotherapy regimen with stem cell support in the previous 6 months
- Troponin I above institution limit of normal
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01832857
Start Date
June 1 2013
End Date
December 1 2016
Last Update
December 29 2016
Active Locations (1)
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1
Eastchester Center for Cancer Care
The Bronx, New York, United States, 10469