Overview

This trial is active, not recruiting.

Condition advanced cancer
Treatment atiprimod
Phase phase 1/phase 2
Sponsor Callisto Pharmaceuticals
Start date March 2005
End date March 2007
Trial size 61 participants
Trial identifier NCT00214838, CP-102

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
The primary objectives of this study are to identify the maximum tolerated dose
time frame:
MTD) and to evaluate the safety of atiprimod when given in doses starting at
time frame:
60 mg/day and ranging to 360 mg/day, or the MTD, whichever is lower, in
time frame:
patients with advanced cancer.
time frame:

Secondary Outcomes

Measure
The secondary objectives of this study are to measure the pharmacokinetics of
time frame:
atiprimod, to evaluate the efficacy of atiprimod treatment in patients with
time frame:
advanced cancer, and to compare the pharmacokinetics of atiprimod tablets and
time frame:
capsules at the starting dose, with the intent of switching to capsules for
time frame:
the dose escalation if the capsules pose no safety issues.
time frame:

Eligibility Criteria

Male or female participants at least 13 years old.

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.

Additional Information

Official title An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Advanced Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2006.
Information provided to ClinicalTrials.gov by Callisto Pharmaceuticals.