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

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Advanced Cancer

In brief

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

Key facts

Study ID

NCT00214838

Run by

Callisto Pharmaceuticals

People needed

61

Starts

2005-03-01

Expected to finish

2007-03-01

Last updated by the study team

2006-12-05

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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