A Study to Evaluate the Safety, Tolerability, and Activity of Lonafarnib and Docetaxel (Study P04467AM1)(TERMINATED)
This study has been terminated.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: October 4, 2007
Last updated: February 4, 2015
Last verified: February 2015
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.
Drug: Docetaxel plus lonafarnib
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
||An Open-Label, Two-Part Study to Determine the Safety, Tolerability, and Activity of Lonafarnib and Docetaxel
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2009 (Final data collection date for primary outcome measure)
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®)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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No publications provided
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 4, 2007
||February 4, 2015
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 03, 2015
Molecular Mechanisms of Pharmacological Action