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: March 5, 2014
Last verified: March 2014

October 4, 2007
March 5, 2014
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
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00539968
P04467
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
March 2014

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