A Study to Evaluate the Safety, Tolerability, and Activity of Lonafarnib and Docetaxel (Study P04467AM1)(TERMINATED)

NCT ID: NCT00539968

Last Updated: 2015-02-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2009-12-31

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.

Conditions

Prostate Cancer; Breast Cancer; Ovarian Cancer; Lung Cancer; Gastric Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Docetaxel plus lonafarnib (single arm)

Docetaxel plus lonafarnib

Group Type: EXPERIMENTAL

Docetaxel plus lonafarnib

Intervention Type: DRUG

Docetaxel: 60-75 mg/m2

Lonafarnib: 150-375 mg PO BID

Interventions

Docetaxel plus lonafarnib

Docetaxel: 60-75 mg/m2

Lonafarnib: 150-375 mg PO BID

Intervention Type: DRUG

Other Intervention Names

Docetaxel (Taxotere®); lonafarnib (SCH 066336, Sarasar®)

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P04467

Identifier Type: -

Identifier Source: org_study_id