An Open-Label Study of the Safety and Efficacy of Atiprim... | NCT00214838

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

NCT00214838

Sponsor

Callisto Pharmaceuticals

Status

Unknown status

Last Update Posted

Dec 5, 2006Estimated

Enrollment

Phase

Phase 1Phase 2

Conditions

Advanced Cancer

Interventions

Atiprimod

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2005

Primary Completion Date

Not provided

Completion Date

Mar 2007

First Submitted Date

Sep 14, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2006

Last Update Posted Date

Dec 5, 2006Estimated

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Atiprimod	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
The secondary objectives of this study are to measure the pharmacokinetics of
atiprimod, to evaluate the efficacy of atiprimod treatment in patients with

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Donald Picker, PhD	Callisto Pharmaceuticals Inc	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MD Anderson Cancer Center		Houston	Texas	77030	United States