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: March 5, 2014
Last verified: March 2014
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
||March 5, 2014
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 16, 2014
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Endocrine Gland Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Endocrine System Diseases
Digestive System Neoplasms
Digestive System Diseases