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

Callisto Pharmaceuticals61 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Cancer

Interventions

AtiprimodDRUG

Eligibility

Sex: ALLMin age: 13 Years

Medical Language ↔ Plain English

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.

Locations (1)

MD Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

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

MTD) and to evaluate the safety of atiprimod when given in doses starting at

60 mg/day and ranging to 360 mg/day, or the MTD, whichever is lower, in

patients with advanced cancer.

Secondary Outcomes

The secondary objectives of this study are to measure the pharmacokinetics of

atiprimod, to evaluate the efficacy of atiprimod treatment in patients with

advanced cancer, and 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.

Data from ClinicalTrials.gov

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