Clinical trial NCT00539968: A Study to Evaluate the Safety, Tolerability, and Activity of Lonafarnib and Docetaxel (Study P04467AM1)(TERMINATED)
Official title: An Open-Label, Two-Part Study to Determine the Safety, Tolerability, and Activity of Lonafarnib and Docetaxel
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Breast Cancer
Ovarian Cancer
Lung Cancer
Gastric Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-10-05
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Incidence of adverse events and dose-limiting toxicities
timeFrame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity
measure: Rate of prostate-specific antigen (PSA) responses
timeFrame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity
Secondary outcomes:
measure: Proportion of subjects with dose-limiting toxicities
timeFrame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity
measure: Plasma lonafarnib concentrations
timeFrame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity
measure: RECIST-defined radiological response rate
timeFrame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity
Other outcomes:
Locations:
Study officials:
References: