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

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00214838
• Other study ID #: CP-102
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: September 14, 2005
• Last updated: December 1, 2006
• Start date: March 2005
• Est. completion date: March 2007

Study information

• Verified date: December 2006
• Source: Callisto Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 61
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

Drug:
• Atiprimod

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Callisto Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objectives of this study are to identify the maximum tolerated dose
Primary	MTD) and to evaluate the safety of atiprimod when given in doses starting at
Primary	60 mg/day and ranging to 360 mg/day, or the MTD, whichever is lower, in
Primary	patients with advanced cancer.
Secondary	The secondary objectives of this study are to measure the pharmacokinetics of
Secondary	atiprimod, to evaluate the efficacy of atiprimod treatment in patients with
Secondary	advanced cancer, and to compare the pharmacokinetics of atiprimod tablets and
Secondary	capsules at the starting dose, with the intent of switching to capsules for
Secondary	the dose escalation if the capsules pose no safety issues.