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

NCT00539968 | Terminated Phase 1

• 1 other identifier: P04467
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events and dose-limiting toxicities

  Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity

• Rate of prostate-specific antigen (PSA) responses

  Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity

Secondary Outcomes (3)

• Proportion of subjects with dose-limiting toxicities

  Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity

• Plasma lonafarnib concentrations

  Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity

• RECIST-defined radiological response rate

  Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity

Study Arms (1)

Docetaxel plus lonafarnib (single arm)

EXPERIMENTAL

Docetaxel plus lonafarnib

Drug: Docetaxel plus lonafarnib

Interventions

Docetaxel plus lonafarnib DRUG

Docetaxel: 60-75 mg/m2 Lonafarnib: 150-375 mg PO BID

Also known as: Docetaxel (Taxotere®); lonafarnib (SCH 066336, Sarasar®)

Docetaxel plus lonafarnib (single arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Prostatic Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Lung Neoplasms; Stomach Neoplasms

Interventions

Docetaxel; lonafarnib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Neoplasms, Female; Endocrine System Diseases; Gonadal Disorders; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2007
• First Posted: October 5, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 5, 2015

Record last verified: 2015-02