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


Phase 1/Phase 2
13 Years
N/A
Open (Enrolling)
Both
Advanced Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The primary objectives of this study are to identify the maximum tolerated dose

Principal Investigator

Donald Picker, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Callisto Pharmaceuticals Inc

Authority:

United States: Food and Drug Administration

Study ID:

CP-102

NCT ID:

NCT00214838

Start Date:

March 2005

Completion Date:

March 2007

Related Keywords:

  • Advanced Cancer
  • cancer, atiprimod
  • Neoplasms

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096