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An Open Label, Phase 2 Trial to Evaluate the Safety, Tolerability and Efficacy of CPI-613 in Cancer Patients

Phase 2
18 Years
Open (Enrolling)
Advanced Solid Tumor Cancer, Metastatic Solid Tumor Cancer

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Trial Information

An Open Label, Phase 2 Trial to Evaluate the Safety, Tolerability and Efficacy of CPI-613 in Cancer Patients

Inclusion Criteria:

- 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 (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

- 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

- 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 Criteria:

- Serious medical illness, such as significant cardiac disease (e.g. symptomatic
congestive heart failure, unstable angina pectoris, myocardial infarction within the
past 6 months, uncontrolled cardiac arrhythmia, or New York Heart Association Class
III or IV), or severe debilitating pulmonary disease, 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

- Pregnant women, or women of child-bearing potential not using reliable means of
contraception (because the teratogenic potential of CPI-613 is unknown)

- Lactating females (Note: Lactating females are excluded because the effects of
CPI-613 on a nursing child are unknown)

- 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 (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

- 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. (Note: Patients with known HIV infection are
excluded because patients with an immune deficiency are at increased risk of lethal
infections when treated with marrow-suppressive therapy, and because there may be
unknown or dangerous drug interactions between CPI-613 and anti-retroviral agents
used to treat HIV infections.)

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival (OS)

Outcome Time Frame:

Monitored until participants pass away, for an expected average of 6 months.

Safety Issue:


Principal Investigator

King C Lee, Ph.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Cornerstone Pharmaceuticals, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

June 2013

Completion Date:

December 2017

Related Keywords:

  • Advanced Solid Tumor Cancer
  • Metastatic Solid Tumor Cancer
  • metastatic
  • advanced
  • solid tumor
  • cancer
  • Neoplasms



Eastchester Center for Cancer CareBronx, New York  10469