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

This study has been completed.

First Received: June 28, 2002 Last Updated: May 31, 2006 History of Changes

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00040547

Purpose

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.

Condition	Intervention	Phase
Neoplasms	Drug: Farnesyl Protein Transferase Inhibitor	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
Official Title:	Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Combination With Docetaxel in Advanced Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Adverse Events
Laboratory Tests
ECG

Secondary Outcome Measures:

Physical Exam
Pharmacokinetics
Tumor Response

Estimated Enrollment:	24
Study Start Date:	June 2001

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Study ID Numbers:	P01964
Study First Received:	June 28, 2002
Last Updated:	May 31, 2006
ClinicalTrials.gov Identifier:	NCT00040547 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Schering-Plough:

Cancer-Advanced Solid Tumors

Study placed in the following topic categories:

Docetaxel

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on July 02, 2009