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

NCT00081510 | Completed Phase 2

• 1 other identifier: P03480
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  When approximately 70 subjects have progressed

Secondary Outcomes (2)

• Objective response rate (adjusted RECIST criteria), duration of response, and overall survival

  When approximately 70 subjects have progressed

• To access the exposure and pk of lonafarnib and anastrazole in the subject population.

  When approximately 70 subjects have progressed

Study Arms (2)

Lonafarnib plus Anastrozole

EXPERIMENTAL

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

Drug: Lonafarnib; Drug: anastrozole

Placebo plus Anastrozole

ACTIVE COMPARATOR

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

Drug: Placebo; Drug: anastrozole

Interventions

Lonafarnib DRUG

Also known as: SCH 66336

Lonafarnib plus Anastrozole

Placebo DRUG

Placebo plus Anastrozole

anastrozole DRUG

Lonafarnib plus Anastrozole; Placebo plus Anastrozole

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

lonafarnib; Anastrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2004
• First Posted: April 16, 2004
• Study Start: December 1, 2003
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: April 15, 2015

Record last verified: 2015-03