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

NCT00741403 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2016-12-29

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Cornerstone Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Karen Gelmon, M.D. · British Columbia Cancer Agency

  • Avi Retter, M.D. · Eastchester Center for Cancer Care

  • Divis K Khaira, M.D. · Pivotal Research Centers

  • Senzer Neil, M.D. · Mary Crowley Cancer Research Centers

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00741403 on ClinicalTrials.gov