Farnesyl Protein Transferase Inhibitor (FPTI) in Combinat... | NCT00040547

Studies
Farnesyl Protein Transferase Inhibitor (FPTI) in Combination With Docetaxel in Advanced Solid Tumors (Study P01964)(COMPLETED)

NCT00040547

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Feb 18, 2015Estimated

Enrollment

29Actual

Phase

Phase 1

Conditions

Neoplasms

Interventions

Farnesyl Protein Transferase Inhibitor

Countries

Not provided

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

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jun 2001

Primary Completion Date

Feb 2004Actual

Completion Date

Feb 2004Actual

First Submitted Date

Jun 28, 2002

First Submission Date that Met QC Criteria

Jun 28, 2002

First Posted Date

Jul 1, 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

Feb 16, 2015

Last Update Posted Date

Feb 18, 2015Estimated

Description Module

Brief Summary

The purpose of this study is to determine the safety and tolerability of an oral Farnesyl Protein Transferase Inhibitor (SCH 66336) when given in combination with intravenous docetaxel in cancer patients with advanced solid tumors.

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

29Actual

Name	Type	Description	Arm Group Labels	Other Names
Farnesyl Protein Transferase Inhibitor	Drug

Eligibility Module

Eligibility Criteria

Inclusion:

Male or Female
Measurable or evaluable disease
No more than 2 prior chemotherapy regimens.
Age greater than or equal to 18.
Karnofsky Performance Status greater than or equal to 70%.
Meets protocol requirements for specified laboratory values.
No manifestations of a malabsorption syndrome.
Written informed consent and cooperation of patient
Appropriate use of effective contraception if of child-bearing potential.

Exclusion:

Acute or chronic leukemia or multiple myeloma.
Evidence of 2 or more active malignancies, expect for in situ or adequately treated basal or squamous cell skin cancer.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C436083	2-(2-oxo-2-((3,7,11-trimethyl-2,6,10-dodecatrienyl)oxy)aminoethyl)phosphonic acid, (2,2-dimethyl-1-oxopropoxy)methyl ester sodium

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
Physical Exam
Pharmacokinetics
Tumor Response