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

December 1, 2006 updated by: Callisto Pharmaceuticals
The primary objectives of this study are to identify the maximum tolerated dose and to evaluate safety of atiprimod in patients with advanced cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment

61

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Callisto Pharmaceuticals

Investigators

  • Study Director: Donald Picker, PhD, Callisto Pharmaceuticals Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Completion

March 1, 2007

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

December 5, 2006

Last Update Submitted That Met QC Criteria

December 1, 2006

Last Verified

December 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Advanced Cancer

Clinical Trials on Atiprimod

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe