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BAY 43-9006 in Treating Patients With Imatinib Mesylate-Resistant Chronic Phase Chronic Myelogenous Leukemia
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00085007
  Purpose

RATIONALE: BAY 43-9006 may stop the growth of cancer cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase II trial is studying how well BAY 43-9006 works in treating patients with imatinib mesylate-resistant chronic phase chronic myelogenous leukemia.


Condition Intervention Phase
Leukemia
Drug: sorafenib tosylate
Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: Imatinib Imatinib mesylate Sorafenib Sorafenib tosylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Open Label Multi-Centric Phase II Study of the Raf Kinase Inhibitor BAY 43-9006 in Chronic Myelogenous Leukemia (CML) Patients Resistant to Gleevec (Imatinib)

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2004
Detailed Description:

OBJECTIVES:

Primary

  • Determine the major hematologic response rate (complete and partial response) in patients with imatinib mesylate-resistant chronic phase chronic myelogenous leukemia.
  • Determine the safety of this drug in these patients.

Secondary

  • Determine the cytogenetic response rate in patients treated with this drug.
  • Determine the duration of hematologic response in patients treated with this drug.
  • Determine the duration of cytogenetic response in patients treated with this drug.
  • Determine time to progression in patients treated with this drug.
  • Determine overall survival of patients treated with this drug.

Tertiary

  • Determined the molecular response in patients treated with this drug.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral BAY 43-9006 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Diagnosis of Philadelphia chromosome-positive chronic myelogenous leukemia in chronic phase
  • Documented hematologic resistance to imatinib mesylate after a prior hematologic response to imatinib mesylate administered at doses of at least 400 mg/day for at least 3 months

    • Documentation of resistance requires at least 2 measurements of WBC > 20,000/mm^3 within 2 weeks

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 16 weeks

Hematopoietic

  • See Disease Characteristics
  • WBC > 20,000/mm^3

Hepatic

  • Bilirubin ≤ 2.0 times upper limit of normal (ULN)
  • ALT and AST ≤ 3 times ULN
  • PT (or INR) and PTT < 1.5 times ULN
  • No chronic hepatitis B or C

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • No New York Heart Association class III or IV congestive heart failure
  • No cardiac arrhythmia requiring antiarrhythmics (excluding beta blockers or digoxin)
  • No active coronary artery disease or ischemia

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception
  • HIV negative
  • No active clinically serious infection
  • No known or suspected allergy to study drugs
  • No other malignancy within the past 3 years except carcinoma in situ of the cervix, adequately treated basal cell skin cancer, or superficial bladder tumors (Ta, Tis, or T1)
  • No substance abuse or medical, psychological, or social condition that would preclude study participation
  • No other concurrent severe disease or comorbidity that would preclude study participation
  • No other unstable condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 2 weeks since prior interferon
  • More than 4 weeks since prior anticancer immunotherapy and recovered
  • No prior allogeneic bone marrow or peripheral blood stem cell transplantation
  • No concurrent bone marrow transplantation or stem cell rescue

Chemotherapy

  • More than 2 days since prior hydroxyurea
  • More than 2 weeks since prior cytarabine at a dose < 100 mg
  • More than 4 weeks since prior cytarabine at a dose > 100 mg
  • More than 4 weeks since other prior anticancer chemotherapy (6 weeks for nitrosoureas, mitomycin, or busulfan) and recovered
  • No concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • No prior solid organ allograft
  • More than 4 weeks since prior significant surgery

Other

  • More than 2 days since prior imatinib mesylate
  • More than 4 weeks since prior investigational drugs
  • Concurrent therapeutic anticoagulation (e.g., warfarin or heparin) allowed as long as no underlying abnormality exists
  • No concurrent antiepileptic drugs for seizure disorders
  • No concurrent ketoconazole, itraconazole, or ritonavir
  • No concurrent products containing grapefruit juice
  • No other concurrent anticancer therapy
  • No other concurrent investigational drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00085007

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1678
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Ronald Paquette, MD Jonsson Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000367117, UCLA-0312018-01, BAYER-10941
Study First Received: June 10, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00085007  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
chronic phase chronic myelogenous leukemia
Philadelphia chromosome positive chronic myelogenous leukemia
relapsing chronic myelogenous leukemia

Study placed in the following topic categories:
Imatinib
Philadelphia Chromosome
Leukemia
Chronic myelogenous leukemia
Hematologic Diseases
Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Leukemia, Myeloid
Bone Marrow Diseases
Sorafenib

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009