A Phase 2 Study of Farnesyl Transferase Inhibitor (R115777, Tipifarnib) in Patients With Refractory or Relapsed Acute Myeloid Leukemia.

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00354146
First received: July 18, 2006
Last updated: January 31, 2011
Last verified: January 2011
  Purpose

The purpose of this study is to evaluate the effectiveness (response rate) and safety of tipifarnib in patients with refractory or relapsed AML.


Condition Intervention Phase
Leukemia, Nonlymphocytic, Acute
Drug: tipifarnib (R115777)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study Evaluating the Efficacy of the Farnesyl Transferase Inhibitor (FTI) R115777 in Patients With Refractory or Relapsed Acute Myeloid Leukemia (AML)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The objective is to determine the rate of complete remission or complete remission with incomplete platelet recovery induced by tipifarnib in patients with refractory or relapsed AML treated until disease progression or unacceptable toxicity occurs.

Secondary Outcome Measures:
  • These objectives are to determine the objective remission rate, duration of remission, time to disease progression/progression-free survival, overall survival, and the clinical benefit/quality of life (QOL). The safety profile will also be determined.

Enrollment: 252
Study Start Date: April 2001
Study Completion Date: July 2003
Detailed Description:

Acute myeloid leukemia (AML) accounts for approximately 25% of all cases of leukemia diagnosed in the Western hemisphere. First-line chemotherapy regimens induce complete remissions in 55-75% of patients. However, between 50% and 70% of patients who achieve remission will relapse. Current therapy for patients refractory to initial therapy or who relapse within 6 months of remission is unsatisfactory because complete remission rates are low and remission duration is brief. New drugs with novel mechanisms of action may be more beneficial than the currently available ones. Tipifarnib represents a new class of oncology drugs which have a specific cellular target (inhibition of the farnesyl transferase protein), one of the components of the Ras oncogene, as its specific mechanism of acton. It is believed that inhibition of this protein will lead to a decrease of cellular proliferation or cell death. This is an open-label, multicenter, non-comparative phase 2 study investigating the efficacy and safety of farnesyl transferase inhibition with tipifarnib administered orally as a single agent, twice daily, for the first 21 days of every 28 day cycle. Patients are enrolled by disease status into two cohorts; Cohort 1 includes patients with relapsed AML and Cohort 2, patients with refractory AML. All patients will be treated for a sufficient length of time to determine response to study medication (effectiveness) by evaluating the rate of complete remission (CR) or complete remission with incomplete platelet recovery (CRp), duration of complete remission, time to disease progression and progression-free survival, overall survival, and to characterize clinical benefit and quality of life (QOL). The safety profile of tipifarnib will also be determined in patients with refractory of relapsed AML.. The patients will receive six tablets (100 mg each) of tipifarnib twice daily for 21 of 28 day cycles (7 day rest period between cycles). Patients may receive tipifarnib until disease progression or unacceptable toxicity occurs.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Refractory or relapsed Acute myeloid leukemia (AML)
  • Eastern Cooperative Oncology Group (ECOG) performance of 0-2
  • any value of WBC
  • able to eat food and medication orally
  • females must use contraception and not be pregnant

Exclusion Criteria:

  • .Not in another study with an investigational agent within 3 weeks of tipifarnib administration
  • must not have active CNS leukemia
  • must not have disseminated intravascular coagulation (DIC) disorder with evidence of hemorrhage
  • must not be allergic to imidazole drugs such as ketoconazole, miconazole, econazole, or terconazole.
  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: NCT00354146

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

No publications provided

ClinicalTrials.gov Identifier: NCT00354146     History of Changes
Other Study ID Numbers: CR004036
Study First Received: July 18, 2006
Last Updated: January 31, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Farnesyl transferase inhibitor
relapsed or refractory acute myeloid leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Tipifarnib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014