Status:
UNKNOWN
An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Advanced Cancer
Lead Sponsor:
Callisto Pharmaceuticals
Conditions:
Advanced Cancer
Eligibility:
All Genders
13+ years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00214838
Start Date
March 1 2005
End Date
March 1 2007
Last Update
December 5 2006
Active Locations (1)
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1
MD Anderson Cancer Center
Houston, Texas, United States, 77030