Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer (P03480)

NCT ID: NCT00081510

Last Updated: 2015-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2009-05-31

Brief Summary

Primary Objective(s):

• To compare the activity (progression-free survival [PFS]) of anastrozole in combination with lonafarnib to that of anastrozole in combination with placebo in subjects with hormone-sensitive ADVANCED breast cancer.

Secondary Objective(s):

• To determine the effects of anastrozole in combination with lonafarnib on objective response, duration of response, overall survival, and safety in subjects with advanced breast cancer. To assess the exposure and pharmacokinetics of lonafarnib and anastrozole in the subject population.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Lonafarnib plus Anastrozole

Participants receive lonafarnib 200 mg orally (PO) twice per day (BID) beginning on Day 1 Cycle 1 and continuing until Progression of Disease, unacceptable toxicity, or other discontinuation criteria are met; and anastrozole 1 mg, PO, once per day (QD) for as long as the participant is receiving lonafarnib

Group Type: EXPERIMENTAL

Lonafarnib

Intervention Type: DRUG

anastrozole

Intervention Type: DRUG

Placebo plus Anastrozole

Participants receive placebo to lonafarnib PO BID beginning on Day 1 Cycle 1 until Progression of Disease, unacceptable toxicity, or other discontinuation criteria are met; and anastrozole, 1mg PO QD for as long as the participant is receiving placebo

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

anastrozole

Intervention Type: DRUG

Interventions

Lonafarnib

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

anastrozole

Intervention Type: DRUG

Other Intervention Names

SCH 66336

Eligibility Criteria

Inclusion Criteria

• Postmenopausal women who have histologically-confirmed breast cancer with the following characteristics:

• estrogen and/or progesterone receptor positive,
• locally advanced disease
• distant metastatic disease, stage 4
• Subjects eligible for single-agent treatment with aromatase inhibitors for current disease.
• Subjects taking biophosphonates are allowed if they begin bisphosphonate therapy AT LEAST two weeks prior to randomization.
• Measurable disease (masses with clearly defined margins on radiological images and at least one diameter >=20 mm[>=10 mm if spiral CT]) or evaluable disease (masses with margins not clearly defined on radiological images or with no diameter >= 20 mm). Subjects with bone disease only are permitted if disease is evaluable.
• ECOG Performance Status of 0 or 1.
• Sufficient bone marrow reserve.
• Adequate hepatic and renal function: laboratory values within protocol requirements.

Exclusion Criteria

• Subjects who have received more than one regimen of cytotoxic chemotherapy for advanced disease.
• Subjects with with CLINICALLY APPARENT brain metastases or extensive visceral disease, including extensive hepatic involvement or pulmonary lymphangitic spread of tumor.
• Subjects with prior treatments with FTIs.
• Subjects with a known or suspected hypersensitivity to any excipients in the lonafarnib formulation (Providone, Poloxamer 188, croscarmellose sodium, silicon dioxide, and magnesium stearate).

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P03480

Identifier Type: -

Identifier Source: org_study_id

NCT00098904

Identifier Type: -

Identifier Source: nct_alias