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

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer Breast Cancer Ovarian Cancer Lung Cancer Gastric Cancer	Drug: Docetaxel plus lonafarnib	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label, Two-Part Study to Determine the Safety, Tolerability, and Activity of Lonafarnib and Docetaxel

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

Drug Information available for: Docetaxel

Genetic and Rare Diseases Information Center resources: Ovarian Cancer Stomach Carcinoma

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:

Incidence of adverse events and dose-limiting toxicities [ Time Frame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity ] [ Designated as safety issue: Yes ]
Rate of prostate-specific antigen (PSA) responses [ Time Frame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Proportion of subjects with dose-limiting toxicities [ Time Frame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity ] [ Designated as safety issue: Yes ]
Plasma lonafarnib concentrations [ Time Frame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity ] [ Designated as safety issue: Yes ]
RECIST-defined radiological response rate [ Time Frame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity ] [ Designated as safety issue: Yes ]


Enrollment:	5
Study Start Date:	June 2007
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Docetaxel plus lonafarnib (single arm) Docetaxel plus lonafarnib	Drug: Docetaxel plus lonafarnib Docetaxel: 60-75 mg/m2 Lonafarnib: 150-375 mg PO BID Other Name: Docetaxel (Taxotere®); lonafarnib (SCH 066336, Sarasar®)

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information

No publications provided


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00539968 History of Changes
Other Study ID Numbers:	P04467
Study First Received:	October 4, 2007
Last Updated:	February 4, 2015
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Docetaxel Antimitotic Agents Antineoplastic Agents Mitosis Modulators	Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses Tubulin Modulators

ClinicalTrials.gov processed this record on March 03, 2015