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A Study to Evaluate the Safety, Tolerability, and Activity of Lonafarnib and Docetaxel (Study P04467AM1)(TERMINATED)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00539968
First Posted: October 5, 2007
Last Update Posted: February 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
This study will determine the best doses of docetaxel and lonafarnib when the two anti-cancer agents are used in combination. Patients with tumors for which treatment with docetaxel would be appropriate are eligible. A second part of the study will further examine the effectiveness of the combination treatment in men with prostate cancer.

Condition Intervention Phase
Prostate Cancer Breast Cancer Ovarian Cancer Lung Cancer Gastric Cancer Drug: Docetaxel plus lonafarnib Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Two-Part Study to Determine the Safety, Tolerability, and Activity of Lonafarnib and Docetaxel

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Incidence of adverse events and dose-limiting toxicities [ Time Frame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity ]
  • Rate of prostate-specific antigen (PSA) responses [ Time Frame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity ]

Secondary Outcome Measures:
  • Proportion of subjects with dose-limiting toxicities [ Time Frame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity ]
  • Plasma lonafarnib concentrations [ Time Frame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity ]
  • RECIST-defined radiological response rate [ Time Frame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity ]

Enrollment: 5
Study Start Date: June 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Docetaxel plus lonafarnib (single arm)
Docetaxel plus lonafarnib
Drug: Docetaxel plus lonafarnib

Docetaxel: 60-75 mg/m2

Lonafarnib: 150-375 mg PO BID

Other Name: Docetaxel (Taxotere®); lonafarnib (SCH 066336, Sarasar®)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • For Part 1: Subjects may be male or female and must be at least 18 years of age.
  • For Part 1: Cancer for which docetaxel treatment is appropriate.
  • For Part 1: Docetaxel-naïve
  • For Part 2: Subjects must be male and at least 18 years of age.
  • For Part 2: Subjects must have adenocarcinoma of the prostate confirmed by histologic/cytologic biopsy.
  • For Part 2: Subjects must have progressive, metastatic, AIPC and a PSA of 10 ng/ml or more after hormonal therapy prior to docetaxel treatment. Progressive disease is defined as a consistently increasing serum PSA level within 28 days prior to docetaxel administration.
  • Adequate organ function within 3 weeks prior to first study drug administration.
  • Performance status (ECOG) is less than or equal to 2.
  • Subject understands and agrees to procedures and participation by signing informed consent form.
  • Agrees to use medically accepted form of contraception.

Exclusion Criteria:

  • Receipt of or need to continue to receive prohibited medications (listed in the protocol) more recently than the washout period (indicated in the protocol).
  • Surgery within 3 weeks prior to first study drug administration.
  • History within 5 years prior to first study drug administration of another malignancy except adequately treated Stage I/II basal/squamous cell skin cancer.
  • Radiation therapy to more than 25% of his/her total bone marrow during life.
  • Radiation therapy within 3 weeks prior to first study drug administration.
  • Known hypersensitivity to prednisone, docetaxel, polysorbate 80, lonafarnib, or any excipients associated with these medications.
  • Known contraindication to steroid use.
  • Known leptomeningeal or CNS metastasis.
  • Heart, vascular, or seizure disorder (detailed list in the protocol) within 6 months prior to first study drug administration.
  • Baseline QTc interval greater than 450 msec.
  • Grade 2 or more peripheral neuropathy or drug-related toxicity per CTCAE. Exceptions are noted in the protocol.
  • Any clinically significant condition or situation that the investigator thinks would interfere with the study evaluations or subject's participation.
  • Subject is part of staff personnel involved in the study.
  • Subject has known clinically significant immunosuppression.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00539968     History of Changes
Other Study ID Numbers: P04467
First Submitted: October 4, 2007
First Posted: October 5, 2007
Last Update Posted: February 5, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Lonafarnib
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors