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A Open Label Phase I/II Clinical Trial to Evaluate CPI-613 in Patients With Advanced Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00741403
Recruitment Status : Completed
First Posted : August 26, 2008
Last Update Posted : December 29, 2016
Information provided by (Responsible Party):
Rafael Pharmaceuticals Inc.

Brief Summary:

An open label, dose-escalation study to evaluate safety, tolerability, maximum tolerated dose (MTD), efficacy, and pharmacokinetics (PKs) of CPI-613 given twice weekly for three consecutive weeks in cancer patients

The objectives of this study are:

  • To determine the safety and MTD of CPI-613 when administered 2x weekly for 3 consecutive weeks.
  • To determine pharmacokinetics of CPI-613 following intravenous (IV) administration.
  • To observe the anti-tumor effects of CPI-613, if any occur.

Condition or disease Intervention/treatment Phase
Advanced Cancer Metastatic Cancer Lymphoma Solid Tumors Advanced Malignancies Drug: CPI-613 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Dose-Escalation Study to Evaluate Safety, Tolerability, Maximum Tolerated Dose (MTD), Efficacy, and Pharmacokinetics (PKs) of CPI-613 Given Twice Weekly for Three Consecutive Weeks in Cancer Patients
Study Start Date : August 2008
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A
IV Infusion of CPI-613 on Days 1,4,8,11,15,18 of 28 day cycle in patients with advanced malignancies
Drug: CPI-613
CPI-613, the investigational drug, is a novel anti-tumor compound believed to operate via a novel mechanism of action that does not belong to any existing pharmacological class of anticancer agents currently being used in the clinics. Specifically, CPI-613 is Cornerstone Pharmaceutical Inc.'s lead drug from its Altered Energy Metabolism-Directed (AEMD) technology platform. It is selective against tumor cells (but not normal cells)according to preclinical studies

Primary Outcome Measures :
  1. To evaluate the safety, tolerability, maximum tolerated dose (MTD), and efficacy pharmacokinetics of CPI-613 given twice weekly for three consecutive weeks in cancer patients [ Time Frame: October 2010 ]

Secondary Outcome Measures :
  1. To evaluate pharmacokinetics, toxicity profile, biological activity, and anti-tumor activity of CPI-613 given twice weekly for three consecutive weeks in cancer patients [ Time Frame: October 2010 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have advanced and/or metastatic, histologically or cytologically documented solid tumors and lymphomas, for whom there is no available therapy shown to provide clinical benefit.
  • Karnofsky Performance Status (KPS) of >70%.
  • Must be ≥18 years of age.
  • Expected survival >3 months.
  • 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), 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 period, unless documentation of infertility exists.
  • Mentally competent, 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 the 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 cytotoxic 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/mm^3 or ≥3.5 bil/L; platelet count ≥100,000 cells/mm^3 or ≥100 bil/L; absolute neutrophil count [ANC] ≥1500 cells/mm^3 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).
    • Adequate coagulation (International Normalized Ratio or INR must be ≤1.25).

Exclusion Criteria:

  • Serious medical illness, such as significant cardiac disease (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.
  • Patients with active central nervous system (CNS) or epidural tumor.
  • Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease).
  • 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 because the potential of excretion of CPI-613 into breast milk. (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.
  • Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients.
  • Unwilling or unable to follow protocol requirements.
  • Dyspnea with minimal to moderate exertion. Patients with large and recurrent pleural, or peritoneal effusions requiring frequent drainage (e.g. weekly). Patients with any amount of clinically significant pericardial effusion.
  • Active heart disease including myocardial infarction within previous 6 months, symptomatic coronary artery disease, arrhythmias requiring medication, or symptomatic congestive heart failure.
  • Albumin <2.5 g/dL or <25 g/L.
  • Evidence of active infection, or serious infection within 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.
  • Requirement for immediate palliative treatment of any kind including surgery.
  • Patients that have received a chemotherapy regimen with stem cell support in the previous 6 months.
  • 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., clinically significant heart failure, hypokalemia, family history of Long QT Syndrome).
  • Troponin I above institution limit of normal or Left Ventricular Ejection Fraction (LVEF) below 35%.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00741403

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United States, Arizona
Pivotal Research Centers
Peoria, Arizona, United States, 85381
United States, New York
Eastchester Center for Cancer Care
Bronx, New York, United States, 10469
United States, Texas
Mary Crowley Cancer Research Centers
Dallas, Texas, United States, 75201
Canada, British Columbia
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Sponsors and Collaborators
Rafael Pharmaceuticals Inc.
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Principal Investigator: Karen Gelmon, M.D. British Columbia Cancer Agency
Principal Investigator: Avi Retter, M.D. Eastchester Center for Cancer Care
Principal Investigator: Divis K Khaira, M.D. Pivotal Research Centers
Principal Investigator: Senzer Neil, M.D. Mary Crowley Cancer Research Centers
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Responsible Party: Rafael Pharmaceuticals Inc. Identifier: NCT00741403    
Other Study ID Numbers: CL-CPI-613-002
First Posted: August 26, 2008    Key Record Dates
Last Update Posted: December 29, 2016
Last Verified: December 2016
Keywords provided by Rafael Pharmaceuticals Inc.:
Phase I
Additional relevant MeSH terms:
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