Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Active 18 and over Pharmaceutical / Industry P04467 NCT00539968

Trial Description

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Schering-Plough Research Institute

Siu-Long Yao, MD

Study Chair

SP Clinical Trial Registry Call Center

Ph: 1-888-772-8734

U.S.A.
Idaho
	Boise
	Investigational Site 12
Maryland
	Bethesda
	Investigational Site 5
Montana
	Missoula
	Investigational Site 7
Texas
	Dallas
	Investigational Site 1
	Investigational Site 11
Colombia
	Bogota
	Investigational 2
	Investigational Site 3
	Pereira
	Investigational Site 4
Ecuador
	Guayaquil
	Investigational Site 10
	Quito
	Investigational Site 9

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00539968
Information obtained from ClinicalTrials.gov on September 29, 2008