A Phase IB Study Of Oral SCH 66336 Preoperatively In Pati... | NCT00038584

Studies
A Phase IB Study Of Oral SCH 66336 Preoperatively In Patients With Head And Neck Squamous Cell Cancer

NCT00038584

Sponsor

M.D. Anderson Cancer Center

Status

Completed

Last Update Posted

Oct 30, 2018Actual

Enrollment

37Actual

Phase

Phase 1

Conditions

Carcinoma, Squamous Cell
Cancer of Head and Neck

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

Jun 1999

Primary Completion Date

Nov 2004Actual

Completion Date

Nov 2004Actual

First Submitted Date

May 31, 2002

First Submission Date that Met QC Criteria

May 31, 2002

First Posted Date

Jun 3, 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

Name	Class
Schering-Plough	INDUSTRY

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

SCH66336 is a drug that has been designed to block the growth of tumor cells and encourage tumor cell death.

This is a randomized study where patients will receive study drug or no drug. Participants in this study are scheduled to have surgery to remove head and neck cancer.

Detailed Description

Not provided

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Name	Type	Description	Arm Group Labels	Other Names
SCH66336	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically-confirmed stage II, III and IV squamous cell carcinoma of the head and neck.
Patient's tumor is fully resectable and does not require radiotherapy to the entire buccal mucosa or patients who are to be treated with definitive radiation therapy as long as adequate (>2cm^3) of tissue can be obtained post-therapy with SCH66336.
ECOG Performance Status of \

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Texas M. D. Anderson Cancer Center		Houston	Texas	77030	United States

Condition Browse Module

MeSH Terms

ID	Term
D002294	Carcinoma, Squamous Cell
D006258	Head and Neck Neoplasms

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

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