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Study of Letrozole Plus Tipifarnib or Placebo in the Treatment of Advanced Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00050141
First received: November 22, 2002
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to determine if the addition of tipifarnib to standard letrozole therapy leads to a better response to treatment for your cancer in comparison to letrozole plus a placebo. Tipifarnib belongs to a class of drugs called Farnesyl Transferase Inhibitors (FTI). It blocks proteins that make cancer cells grow.


Condition Intervention Phase
Breast Cancer
Drug: ZARNESTRA, tipifarnib, R115777
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomised, Blinded, Phase 2 Study of Letrozole Plus the Farnesyl Transferase Inhibitor ZARNESTRA TM (R115777) and Letrozole Plus Placebo in the Treatment of Advanced Breast Cancer After Antiestrogen Therapy.

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Comparisons between the two treatment groups will be made for patients who have achieve a confirmed Complete Response (CR) or Partial Response (PR).

Secondary Outcome Measures:
  • Effectiveness will be assessed by time to disease progression; time to treatment failure; duration of response; clinical benefit; duration of clinical benefit; survival time. The study will include evaluations of safety and tolerability.

Enrollment: 121
Study Start Date: September 2002
Study Completion Date: January 2008
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Detailed Description:

This clinical study involves two groups of patients with advanced breast cancer. One group (2/3rds of all the patients) will be taking tipifarnib in combination with another anticancer drug called letrozole, and the other group (1/3rd of all the patients) will be taking letrozole plus a placebo (an inactive substance given in the same form as a real drug). The assignment to one of these two groups will be by chance (like flipping a coin). Unless the need arises, neither the patient nor the study staff will know whether the patient is receiving tipifarnib with the letrozole. Comparisons between the two groups will be made for patients who have achieve a confirmed Complete Response (CR) or Partial Response (PR). The interval between the date of randomization and the earliest date of disease progression will also be assessed. The study will include evaluations of safety and tolerability. Patients should expect their participation in this trial to last a minimum of 4 to 8 weeks. Their participation could continue for several months or beyond a year, depending on how their disease responds to the treatment. After completing study treatment, patients will be asked to attend for an End of Treatment visit and then a posttreatment Follow-up visit 4 to 6 weeks after stopping the medication. Patients will be randomly assigned to treatment with either 2.5 mg letrozole once daily plus placebo to match tipifarnib twice daily, or 2.5 mg letrozole once daily plus 300 mg tipifarnib twice daily. Both tipifranib and matching placebo will be given in 28-day cycles of 21 days of treatment followed by 7 days rest. All patients will receive continuous treatment with letrozole.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Locally advanced, inoperable loco-regionally-recurrent, or metastatic breast cancer
  • Estrogen and/or progesterone positive disease
  • Progression of disease after antiestrogen therapy
  • Measurable disease
  • Postmenopausal
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.

Exclusion Criteria:

  • Previous endocrine therapy, other than antiestrogen therapy
  • More than 1 prior chemotherapy regimen
  • Previous therapy with farnesyl transferase inhibitor
  • Presence of rapidly progressive, life-threatening metastases
  • Concomitant anticancer treatment
  • Other malignancy within the past 5 years
  • Symptomatic peripheral neuropathy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050141

Locations
United States, Florida
Miami, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, North Carolina
Durham, North Carolina, United States
United States, Ohio
Cleveland, Ohio, United States
United States, Texas
Fort Worth, Texas, United States
Tyler, Texas, United States
Belgium
Brussel, Belgium
Leuven, Belgium
France
Bordeaux Cedex, France
Clermont Ferrand Cedex 1, France
Montpellier Cedex 5 N/A, France
Rennes Cedex, France
Saint Herblain, France
Vandoeuvre Les Nancy, France
Netherlands
Den Haag, Netherlands
Russian Federation
Moscow, Russian Federation
Moscow N/A, Russian Federation
St Petersburg, Russian Federation
St Petersburg N/A, Russian Federation
United Kingdom
Huddersfield, United Kingdom
Leeds, United Kingdom
London, United Kingdom
Manchester, United Kingdom
Newcastle Upon Tyne, United Kingdom
Sutton, United Kingdom
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00050141     History of Changes
Obsolete Identifiers: NCT00060177, NCT00723372
Other Study ID Numbers: CR004030
Study First Received: November 22, 2002
Last Updated: January 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Breast cancer
ZARNESTRA
tipifarnib
R115777
Estrogen receptor positive
Progesterone receptor positive
Anti-estrogen therapy

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

ClinicalTrials.gov processed this record on November 24, 2014