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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2007-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Advanced Cancer

Keywords

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cancer, atiprimod

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Atiprimod

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Donald Picker, PhD

Role: STUDY_DIRECTOR

Callisto Pharmaceuticals Inc

Locations

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MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CP-102

Identifier Type: -

Identifier Source: org_study_id