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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Leukemia

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Trial Information

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)


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Ronald Paquette, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000367117

NCT ID:

NCT00085007

Start Date:

March 2004

Completion Date:

Related Keywords:

  • Leukemia
  • chronic phase chronic myelogenous leukemia
  • chronic myelogenous leukemia, BCR-ABL1 positive
  • relapsing chronic myelogenous leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781