Know Cancer

or
forgot password

Long-Term Safety and Efficacy of Dasatinib (BMS-354825) in Subjects Who Experienced Clinical Benefit on Protocol CA 180-002


Phase 1
18 Years
N/A
Not Enrolling
Both
Leukemia

Thank you

Trial Information

Long-Term Safety and Efficacy of Dasatinib (BMS-354825) in Subjects Who Experienced Clinical Benefit on Protocol CA 180-002


OBJECTIVES:

Primary

- Determine the long-term safety and tolerability of dasatinib in patients with
Philadelphia chromosome-positive chronic myelogenous leukemia or acute lymphoblastic
leukemia resistant or intolerant to imatinib mesylate.

Secondary

- Describe any hematologic or cytogenetic response in patients treated with this drug.

- Determine the duration of hematologic and cytogenetic response in patients using this
drug during trial UCLA-0303035.

- Determine the progression-free survival and overall survival of patients treated with
this drug.

OUTLINE: This is an open-label, roll-over study of protocol UCLA-0303035.

Patients receive oral dasatinib once or twice daily for 5, 6, or 7 days. Treatment repeats
every 7 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of one of the following hematologic malignancies:

- Chronic phase chronic myelogenous leukemia (CML)

- In complete hematologic response after treatment on protocol UCLA-0303035,
as indicated by the following criteria:

- WBC ≤ upper limit of normal (ULN)

- Platelet count < 450,000/mm^3

- No blasts or promyelocytes in peripheral blood

- Less than 5% myelocytes plus metamyelocytes in peripheral blood

- Peripheral blood basophils ≤ ULN

- No extramedullary involvement (including no hepatomegaly or
splenomegaly)

- Response lasting ≥ 4 weeks after first documentation

- Accelerated or blastic phase CML or acute lymphoblastic leukemia

- In major hematologic response* after treatment on protocol UCLA-0303035,
defined as 1 of the following:

- In complete hematologic response*, as indicated by the following
criteria:

- WBC ≤ ULN

- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 100,000/mm^3

- No blasts or promyelocytes in peripheral blood

- Bone marrow blasts ≤ 5%

- Less than 5% myelocytes plus metamyelocytes in peripheral blood

- Peripheral blood basophils ≤ ULN

- No extramedullary involvement (including no hepatomegaly or
splenomegaly)

- No evidence of leukemia, as indicated by the following criteria:

- WBC ≤ ULN

- No blasts or promyelocytes in the peripheral blood

- Bone marrow blasts ≤ 5%

- Less than 5% myelocytes plus metamyelocytes in peripheral blood

- Peripheral blood basophils ≤ ULN

- No extramedullary involvement (including no hepatomegaly or
splenomegaly)

- Absolute neutrophil count ≥ 500/mm^3 and < 1,000/mm^3 AND
platelet count ≥ 20,000/mm^3 and < 100,000/mm^3

- In minor hematologic response* after treatment on protocol UCLA-0303035, as
indicated by the following criteria:

- Less than 15% in bone marrow and < 15% in peripheral blood

- Less than 30% blasts plus promyelocytes in bone marrow and < 30%
blasts plus promyelocytes in peripheral blood

- Less than 20% basophils in peripheral blood

- No extramedullary disease other than spleen and liver NOTE: *Response
confirmed after ≥ 4 weeks allowed provided there is no concurrent
anagrelide or hydroxyurea during this time

- Philadelphia chromosome-positive (Ph+) disease

- Resistant or intolerant to prior imatinib mesylate

- Received and benefitted from ≥ 3 months of prior therapy with dasatinib on protocol
UCLA-0303035

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 12 weeks after
completion of study treatment

- No serious uncontrolled medical disorder

- No active infection that would preclude study participation

- No uncontrolled angina within the past 3 months

- No diagnosed or suspected congenital long QT syndrome

- No history of clinically significant ventricular arrhythmias (e.g., ventricular
tachycardia, ventricular fibrillation, or torsades de pointes)

- QTc ≤ 450 msec on electrocardiogram

- No uncontrolled hypertension

- No dementia or altered mental status the would prohibit the understanding or
rendering of informed consent

- No history of the following significant bleeding disorders unrelated to CML:

- Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)

- Diagnosed acquired bleeding disorder in the past year (e.g., acquired antifactor
VIII antibodies)

- Not involuntarily incarcerated for either psychiatric or physical (e.g., infectious
disease) illness

- No patients who are imprisoned

- No clinical adverse event, laboratory abnormality, or intercurrent illness that may
preclude study treatment, in the opinion of the investigator

- Bilirubin < 1.5 mg/dL

- ALT and AST < 2 times upper limit of normal (ULN)

- Creatinine < 1.5 times ULN

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No concurrent use of the following drugs that may confer risk of torsades de pointes:

- Quinidine

- Procainamide

- Disopyramide

- Amiodarone

- Sotalol

- Ibutilide

- Dofetilide

- Erythromycin

- Clarithromycin

- Chlorpromazine

- Haloperidol

- Mesoridazine

- Thioridazine

- Pimozide

- Cisapride

- Bepridil

- Droperidol

- Methadone

- Arsenic

- Chloroquine

- Domperidone

- Halofantrine

- Levomethadyl

- Pentamidine

- Sparfloxacin

- Lidoflazine

- No other concurrent treatment for CML except for hydroxyurea for a 2-week duration

- No concurrent medications that inhibit platelet function (e.g., aspirin,
dipyridamole, epoprostenol, eptifibatide, clopidogrel, cilostazol, abciximab,
ticlopidine, or any nonsteroidal anti-inflammatory drug)* except for hydroxyurea or
anagrelide

- No concurrent anticoagulants (e.g., warfarin or heparin/low molecular weight heparin
[e.g., danaparoid, dalteparin, tinzaparin, or enoxaparin]) except as prophylaxis for
catheter thrombosis and/or heparin flushes for IV lines* NOTE: *Allowed if received
previously on UCLA-0303035

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Long term safety and tolerability

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Charles Sawyers, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CDR0000480396

NCT ID:

NCT00345826

Start Date:

November 2005

Completion Date:

Related Keywords:

  • Leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • chronic phase chronic myelogenous leukemia
  • relapsing chronic myelogenous leukemia
  • recurrent adult acute lymphoblastic leukemia
  • chronic myelogenous leukemia, BCR-ABL1 positive
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

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