Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer (Study P03480AM5)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00081510
First received: April 14, 2004
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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.

Condition Intervention Phase
Breast Cancer
Drug: Lonafarnib plus Anastrozole
Drug: Placebo plus Anastrozole
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind Phase-2 Study of Anastrozole Plus Lonafarnib (SCH 66336) or Anastrozole Plus Placebo for the Treatment of Subjects With Advanced Breast Cancer

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: When approximately 70 subjects have progressed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate (adjusted RECIST criteria), duration of response, and overall survival [ Time Frame: When approximately 70 subjects have progressed ] [ Designated as safety issue: Yes ]
  • To access the exposure and pk of lonafarnib and anastrazole in the subject population. [ Time Frame: When approximately 70 subjects have progressed ] [ Designated as safety issue: Yes ]

Enrollment: 110
Study Start Date: December 2003
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lonafarnib plus Anastrozole Drug: Lonafarnib plus Anastrozole
Lonafarnib 200 mg PO BID beginning on Cycle 1 Day 1 and continuously until Progression of Disease, unacceptable toxicity, or other discontinuation criteria. Subjects will be treated concomitantly with anastrozole (1 mg PO QD) continuously.
Other Name: SCH 66336
Active Comparator: Placebo plus Anastrozole Drug: Placebo plus Anastrozole
Placebo PO BID beginning on Cycle 1 Day 1 and continuously until Progression of Disease, unacceptable toxicity, or other discontinuation criteria. Subjects will be treated concomitantly with anastrozole (1 mg PO QD) continuously.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00081510     History of Changes
Obsolete Identifiers: NCT00098904
Other Study ID Numbers: P03480
Study First Received: April 14, 2004
Last Updated: March 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014