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

Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Combination With Docetaxel in Advanced Solid Tumors

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00040547
Enrollment
29
Registered
2002-07-01
Start date
2001-06-30
Completion date
2004-02-29
Last updated
2015-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

Cancer-Advanced Solid Tumors

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.

Interventions

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frame
Adverse Events
Laboratory Tests
ECG

Secondary

MeasureTime frame
Physical Exam
Pharmacokinetics
Tumor Response

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026