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

• Status: Unknown status
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Callisto Pharmaceuticals

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.