Tipifarnib Versus Best Supportive Care in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) - Full Text View

Tipifarnib Versus Best Supportive Care in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)

This study is ongoing, but not recruiting participants.

Sponsored by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00093990

Purpose

This study tests the effectiveness of tipifarnib in older patients with acute myeloid leukemia.

In this study, half the patients will receive tipifarnib and the other half of the patients will receive the standard treatment of the hospital.

Condition	Intervention	Phase
Myeloid Leukemia Acute Disease	Procedure: Bone marrow aspirate Drug: Tipifarnib	Phase III

ChemIDplus related topics:

Hydroxyurea Tipifarnib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

Official Title:	A Randomized Study of Tipifarnib Versus Best Supportive Care (Including Hydroxyurea) in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) in Subjects 70 Years or Older (Farnesyl Transferase Inhibition Global Human Trials AML 301 [F.I.G.H.T. AML 301])

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

Primary Outcome Measures:

survival status

Estimated Enrollment:

450

Eligibility

Ages Eligible for Study:	70 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

70 years or older
Newly diagnosed, de novo or secondary AML
Subject not medically fit for combination induction chemotherapy
Pathologic confirmation of AML (= or > 20% bone marrow leukemic blasts)
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
Subject has signed the informed consent document. Consent may not be given by a legal representative.

Exclusion Criteria:

More than 3 weeks since diagnosis
Previous cytotoxic or biologic treatment for AML
Acute promyelocytic leukemia (APL)
Absolute peripheral blast count >30,000/mm3
Central nervous system leukemia
Serum biochemical values as follows:
- Serum creatinine greater than 1.5 times ULN (CTC Grade 1)
- Total bilirubin greater than 1.5 times ULN (CTC Grade 1), unless the increase is unequivocally due to hemolysis
- ALT (alanine transaminase) and AST (aspartate transaminase) greater than 2.5 times ULN (CTC Grade 1)
Uncontrolled systemic infection
Uncompensated disseminated intravascular coagulation
Symptomatic neuropathy of grade 2 or worse
Known allergy to imidazole drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093990

Show 134 Study Locations

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators


Study Director:	Johnson & Johnson Pharmaceutical Research and Development L.L.C. Clinical Trial	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

Study ID Numbers:	R115777-AML-301
First Received:	October 7, 2004
Last Updated:	September 20, 2007
ClinicalTrials.gov Identifier:	NCT00093990
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Acute Myeloid Leukemia

Study placed in the following topic categories:

Acute Disease

Leukemia

Hydroxyurea

Acute myelogenous leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Acute myelocytic leukemia

Tipifarnib

Additional relevant MeSH terms:

Neoplasms

Disease Attributes

Neoplasms by Histologic Type

Pathologic Processes

Antineoplastic Agents

Therapeutic Uses

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2008