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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:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00539968
First received: October 4, 2007
Last updated: February 4, 2015
Last verified: February 2015

October 4, 2007
February 4, 2015
June 2007
December 2009   (final data collection date for primary outcome measure)
  • Incidence of adverse events and dose-limiting toxicities [ Time Frame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity ] [ Designated as safety issue: Yes ]
  • Rate of prostate-specific antigen (PSA) responses [ Time Frame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00539968 on ClinicalTrials.gov Archive Site
  • Proportion of subjects with dose-limiting toxicities [ Time Frame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity ] [ Designated as safety issue: Yes ]
  • Plasma lonafarnib concentrations [ Time Frame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity ] [ Designated as safety issue: Yes ]
  • RECIST-defined radiological response rate [ Time Frame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
A Study to Evaluate the Safety, Tolerability, and Activity of Lonafarnib and Docetaxel (Study P04467AM1)(TERMINATED)
An Open-Label, Two-Part Study to Determine the Safety, Tolerability, and Activity of Lonafarnib and Docetaxel
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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Prostate Cancer
  • Breast Cancer
  • Ovarian Cancer
  • Lung Cancer
  • Gastric Cancer
Drug: Docetaxel plus lonafarnib

Docetaxel: 60-75 mg/m2

Lonafarnib: 150-375 mg PO BID

Other Name: Docetaxel (Taxotere®); lonafarnib (SCH 066336, Sarasar®)
Experimental: Docetaxel plus lonafarnib (single arm)
Docetaxel plus lonafarnib
Intervention: Drug: Docetaxel plus lonafarnib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
December 2009
December 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Colombia,   Ecuador,   United States
 
NCT00539968
P04467
No
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP