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

Merck Sharp & Dohme (MSD)

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Breast Cancer

Gastric Cancer

Lung Cancer

Ovarian Cancer

Prostate Cancer

Treatments

Drug: Docetaxel plus lonafarnib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00539968

P04467

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.