NCT00214838

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
61

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

December 5, 2006

Status Verified

December 1, 2006

First QC Date

September 14, 2005

Last Update Submit

December 1, 2006

Conditions

Advanced Cancer

Keywords

cancer, atiprimod

Outcome Measures

Primary Outcomes (4)

  • 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 (5)

  • 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.

Interventions

AtiprimodDRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

azaspirane

Study Officials

  • Donald Picker, PhD

    Callisto Pharmaceuticals Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

March 1, 2005

Study Completion

March 1, 2007

Last Updated

December 5, 2006

Record last verified: 2006-12

Locations

US(1)