Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT00539968
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00539968
Study Brief:
Protocol Section:
NCT00539968