Phase II Study of SCH66336, A Farnesyltransferase Inhibit... | NCT00038597

Studies
Phase II Study of SCH66336, A Farnesyltransferase Inhibitor in Chronic Myelogenous Leukemia (CML)

NCT00038597

Sponsor

M.D. Anderson Cancer Center

Status

Completed

Last Update Posted

Oct 30, 2018Actual

Enrollment

13Actual

Phase

Phase 2

Conditions

Myelogenous Leukemia, Chronic

Interventions

SCH66336

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

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 30, 2001Actual

Primary Completion Date

May 7, 2004Actual

Completion Date

May 7, 2004Actual

First Submitted Date

Jun 3, 2002

First Submission Date that Met QC Criteria

Jun 3, 2002

First Posted Date

Jun 4, 2002Estimated

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

Oct 29, 2018

Last Update Posted Date

Oct 30, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this research is to see if giving the drug SCH66336 by mouth can improve the disease in patients with chronic or accelerated phase CML. The safety of this treatment will also be studied.

Detailed Description

Objectives for this study are two-fold:

To determine the efficacy of SCH66336 in patients with chronic phase and accelerated phase CML in relation to response rate, duration of response, and survival.
To assess the toxicity of SCH66366 in these patients.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Name	Type	Description	Arm Group Labels	Other Names
SCH66336	Drug

Eligibility Module

Eligibility Criteria

Diagnosis of Philadelphia chromosome (Ph) -positive CML in chronic or accelerated phase;
Failure to respond to or intolerance to imatinib mesylate (Gleevec);
Age >/= 16 years;
Life expectancy of >/= 2 months;
Performance status 2 or better (Zubrod);
Adequate renal and hepatic functions (creatinine and bilirubin \

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 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
Jorge Cortes, MD	UT MD Anderson Cancer Center	Principal Investigator

Locations

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

Label	URL
UT MD Anderson Cancer Center Website	View source

Condition Browse Module

MeSH Terms

ID	Term
D015464	Leukemia, Myelogenous, Chronic, BCR-ABL Positive
D015466	Leukemia, Myeloid, Chronic-Phase
D007951	Leukemia, Myeloid
D000092122	Bronchiolitis Obliterans Syndrome

Ancestor Terms

ID	Term
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009196	Myeloproliferative Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C115354	lonafarnib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided