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

Breast Cancer Clinical Trial

Official title:

An Open-Label, Two-Part Study to Determine the Safety, Tolerability, and Activity of Lonafarnib and Docetaxel

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00539968
• Other study ID #: P04467
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: October 4, 2007
• Last updated: February 4, 2015
• Start date: June 2007
• Est. completion date: December 2009

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Gastric Cancer
• Lung Cancer
• Ovarian Cancer
• Prostate Cancer

Intervention

Drug:
• Docetaxel plus lonafarnib
Docetaxel: 60-75 mg/m2 Lonafarnib: 150-375 mg PO BID

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events and dose-limiting toxicities		Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity	Yes
Primary	Rate of prostate-specific antigen (PSA) responses		Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity	Yes
Secondary	Proportion of subjects with dose-limiting toxicities		Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity	Yes
Secondary	Plasma lonafarnib concentrations		Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity	Yes
Secondary	RECIST-defined radiological response rate		Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity	Yes