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Completed

NCT Number: NCT00040547

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

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.

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Key information

Conditions

Neoplasms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Farnesyl Protein Transferase Inhibitor

Drug

Primary outcomes

  1. Adverse Events

  2. Laboratory Tests

  3. ECG

Secondary outcomes

  1. Physical Exam

  2. Pharmacokinetics

  3. Tumor Response

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2004
Study completion
2004
First posted
Jul 1, 2002
Registry last updated
Feb 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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