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A Open Label Phase I/II Clinical Trial to Evaluate CPI-613 in Patients With Advanced Malignancies
This study is currently recruiting participants.
Verified by Cornerstone Pharmaceuticals, Inc., September 2008
Sponsored by: Cornerstone Pharmaceuticals, Inc.
Information provided by: Cornerstone Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00741403
  Purpose

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 Intervention Phase
Advanced Cancer
Metastatic Cancer
Lymphoma
Solid Tumors
Advanced Malignancies
Drug: CPI-613
Phase I
Phase II

MedlinePlus related topics: Cancer Lymphoma
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Cornerstone Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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: November 2009 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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: November 2009 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: August 2008
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Advanced Cancer: Experimental IV injection of CPI-613 on Days 1, 3,8,10,15,17 of 28 day cycle in patients with advanced malignancies
Drug: CPI-613
CPI-613, the investigational drug, is a novel anti-tumor compound presumably with a novel mechanism of action that does not belong to any existing pharmacological class of anticancer agents currently used in the clinics. Specifically, CPI-613 is referred to as an Altered Energy Metabolism-Directed (AEMD) compound, and it is selective against tumor cells (but not normal cells) according to preclinical studies.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Karnofsky Performance Status (KPS) > 70%.
  • Expected Survival > 3 months.
  • Advanced or metastatic, histologically or cytologically documented solid tumors, lymphomas, for which there is no available therapy shown to provide clinical benefit.
  • Adequate renal, liver, pancreatic and hematological function
  • Signed informed consent
  • Mentally competent. Ability to understand and willingness to sign the informed consent form.
  • Willingness to practice birth control

Exclusion Criteria:

  • Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past 4 weeks prior to initiation of CPI-613.
  • Patients with an active tumor of the central nervous system ( CNS) or epidural tumor
  • Patients with active heart disease including myocardial infarction within previous 6 months, symptomatic coronary artery disease, arrhythmias requiring medication, or symptomatic congestive heart failure.
  • History of risk factors for Torsades de Pointes ( heart failure, hypokalemia, family history of Long QT Syndrome
  • Patients with a marked baseline QT/QTc interval > 450ms (e.g., heart failure, hypokalemia, and family history of Long QT Syndrome).
  • Serious medical illness such as significant cardiac disease ( Symptomatic CHF, 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 the patients risk for developing toxicityTroponin I >0.05ng/mL or Left Ventricular Ejection Fraction ( LVEF) below 35%
  • Dyspnea with mild exertion
  • Pregnant or breast-feeding women.
  • Concurrent, active secondary malignancy for which the patient is receiving therapy.
  • Requirement for immediate palliative treatment of any kind including surgery.
  • Patients who have received immunotherapy in the past 4 weeks prior to initiation of CPI-613
  • Patients who are known to be HIV positive
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741403

Contacts
Contact: Richard A. Lutes, M.D. 203-262-1232 richard@cornerstone.com

Locations
United States, California
Tower Cancer Research Recruiting
Beverly Hills, California, United States, 90211
Contact: Peter Rosen, MD            
Contact: Marie Fuerst, MS RN     310-285-7269        
Principal Investigator: Peter Rosen, MD            
Canada, British Columbia
British Columbia Cancer Center Not yet recruiting
Vancouver, British Columbia, Canada
Contact: Karen Gelmon, MD     604-877-6000 ext 2032        
Principal Investigator: Karen Gelmon, MD            
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Lillian Siu, MD FRCPC     416-946-2911        
Principal Investigator: Lillian Siu, MD FRCPC            
Sponsors and Collaborators
Cornerstone Pharmaceuticals, Inc.
Investigators
Principal Investigator: Lillian Siu, M.D. FRCPC Princess Margaret Hospital, Canada
  More Information

Responsible Party: Cornerstone Pharmaceutiecals, Inc ( Richard Lutes, MD )
Study ID Numbers: CL-CPI-613-002
Study First Received: August 25, 2008
Last Updated: September 8, 2008
ClinicalTrials.gov Identifier: NCT00741403  
Health Authority: United States: Food and Drug Administration;   Canada: Health Canada

Keywords provided by Cornerstone Pharmaceuticals, Inc.:
Phase I
Phase II
malignancies
refractory
relapsed

Study placed in the following topic categories:
Lymphatic Diseases
Immunoproliferative Disorders
Neoplasm Metastasis
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009