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

Callisto Pharmaceuticals

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Advanced Cancer

Treatments

Drug: Atiprimod

Study type

Interventional

Funder types

Industry

Identifiers

NCT00214838

CP-102

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

13+ years old

Volunteers

No Healthy Volunteers

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.