Phase 2 Safety, Tolerability and Efficacy Study of CPI-613 in Cancer Patients

Stopped early · Phase 2

Conditions studied: Cancer

In brief

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 benefit or for those who have refused further standard therapy. The primary outcome measure is Overall Survival (OS). The secondary outcome measures are: Response Rate (RR), Progression-Free Survival (PFS), and safety.

Key facts

Study ID

NCT01832857

Run by

Cornerstone Pharmaceuticals

People needed

7

Starts

2013-06-01

Expected to finish

2016-12-01

Last updated by the study team

2016-12-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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")

You may not qualify if…

• 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

Where it is running

• Eastchester Center for Cancer Care — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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