An Open-Label, Two-Part Study to Determine the Safety, Tolerability, and Activity of Lonafarnib and Docetaxel
- 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
- 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
- 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
- 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.