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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Callisto Pharmaceuticals.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Callisto Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00214838
First received: September 14, 2005
Last updated: December 1, 2006
Last verified: December 2006
  Purpose

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


Condition Intervention Phase
Advanced Cancer
Drug: Atiprimod
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by Callisto Pharmaceuticals:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 61
Study Start Date: March 2005
Estimated Study Completion Date: March 2007
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00214838

Locations
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Callisto Pharmaceuticals
Investigators
Study Director: Donald Picker, PhD Callisto Pharmaceuticals Inc
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00214838     History of Changes
Other Study ID Numbers: CP-102
Study First Received: September 14, 2005
Last Updated: December 1, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Callisto Pharmaceuticals:
cancer, atiprimod

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 28, 2014