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An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Advanced Cancer

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.
 
ClinicalTrials.gov Identifier: NCT00214838
Recruitment Status : Unknown
Verified December 2006 by Callisto Pharmaceuticals.
Recruitment status was:  Active, not recruiting
First Posted : September 22, 2005
Last Update Posted : December 5, 2006
Sponsor:
Information provided by:
Callisto Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE September 14, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date December 5, 2006
Study Start Date  ICMJE March 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2006)
  • The primary objectives of this study are to identify the maximum tolerated dose
  • MTD) and to evaluate the safety of atiprimod when given in doses starting at
  • 60 mg/day and ranging to 360 mg/day, or the MTD, whichever is lower, in
  • patients with advanced cancer.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00214838 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2006)
  • The secondary objectives of this study are to measure the pharmacokinetics of
  • atiprimod, to evaluate the efficacy of atiprimod treatment in patients with
  • advanced cancer, and to compare the pharmacokinetics of atiprimod tablets and
  • capsules at the starting dose, with the intent of switching to capsules for
  • the dose escalation if the capsules pose no safety issues.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Advanced Cancer
Official Title  ICMJE An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Advanced Cancer
Brief Summary The primary objectives of this study are to identify the maximum tolerated dose and to evaluate safety of atiprimod in patients with advanced cancer.
Detailed Description

The primary objectives of this study are to identify the maximum tolerated dose(MTD) and to evaluate safety of atiprimod in patients with advanced cancer.

The secondary objectives of this study are 1) to measure the pharmacokinetics of atiprimod and 2) to evaluate the efficacy of atiprimod treatment in patients with advanced cancers and 3) to compare the pharmacokinetics of atiprimod tablets and capsules at the starting dose, with the intent of switching to capsules for the dose escalation if the capsules pose no safety issues.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Cancer
Intervention  ICMJE Drug: Atiprimod
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: September 20, 2006)
61
Original Enrollment  ICMJE
 (submitted: September 14, 2005)
34
Study Completion Date  ICMJE March 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • histological proof of advanced cancer and must have failed or relapsed following standard therapy or have no standard therapy available.
  • estimated life expectancy of at least 12 weeks.
  • must have evaluable disease.
  • ECOG(Zubrod) PS of 0 to 2
  • sign informed consent.
  • age 13 years or more at time of signing informed consent.

Exclusion Criteria:

  • renal insufficiency
  • concomitant radiotherapy, chemotherapy or other investigational therapies.
  • peripheral neuropathy grade 3 or greater (NCI CTC version 3 grading)
  • evidence of clinically significant mucosal or internal bleeding
  • any condition that in the opinion of the investigator, places the patient at unacceptable risk if he/she were to participate in the study.
  • clinically relevant active infection or serious co-morbid medical conditions.
  • as atiprimod is a potent inhibitor of CYP2D6, patients taking drugs that are substrates of CYP2D6(e.g. beta blockers, antidepressants and antipsychotics will be excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00214838
Other Study ID Numbers  ICMJE CP-102
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Callisto Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Donald Picker, PhD Callisto Pharmaceuticals Inc
PRS Account Callisto Pharmaceuticals
Verification Date December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP