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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer; Breast Cancer; Ovarian Cancer; Lung Cancer; Gastric Cancer	Drug: Docetaxel plus lonafarnib	Phase 1; Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	5 participants
Allocation:	Non-Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	An Open-Label, Two-Part Study to Determine the Safety, Tolerability, and Activity of Lonafarnib and Docetaxel
Study Start Date :	June 2007
Actual Primary Completion Date :	December 2009
Actual Study Completion Date :	December 2009

Arms and Interventions

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Arm	Intervention/treatment
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®)

Outcome Measures

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Primary Outcome Measures :

1. Incidence of adverse events and dose-limiting toxicities [ Time Frame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity ]
2. Rate of prostate-specific antigen (PSA) responses [ Time Frame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity ]

Secondary Outcome Measures :

1. Proportion of subjects with dose-limiting toxicities [ Time Frame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity ]
2. Plasma lonafarnib concentrations [ Time Frame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity ]
3. RECIST-defined radiological response rate [ Time Frame: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00539968 History of Changes
Other Study ID Numbers:	P04467
First Posted:	October 5, 2007
Last Update Posted:	February 5, 2015
Last Verified:	February 2015

Additional relevant MeSH terms:

Stomach Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases	Docetaxel; Lonafarnib; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors