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An Open Label Study to Investigate the Maximum Tolerated Dose of RO5045337 in Patients With Acute Myelogenous Leukemia (AML), Acute Lymphocytic Leukemia (ALL), Chronic Myelogenous Leukemia (CML) in Blast Phase, or Refractory Chronic Lymphocytic Leukemia/Small Cell Lymphocytic Lymphoma (CLL / SCLL)


Phase 1
18 Years
N/A
Not Enrolling
Both
Hematologic Neoplasms

Thank you

Trial Information

An Open Label Study to Investigate the Maximum Tolerated Dose of RO5045337 in Patients With Acute Myelogenous Leukemia (AML), Acute Lymphocytic Leukemia (ALL), Chronic Myelogenous Leukemia (CML) in Blast Phase, or Refractory Chronic Lymphocytic Leukemia/Small Cell Lymphocytic Lymphoma (CLL / SCLL)


Inclusion Criteria:



- Adult patients, >=18 years of age

- Acute myeloid leukemia, acute lymphocytic leukemia, chronic myelogenous leukemia in
blast phase, refractory chronic lymphocytic leukemia/small cell lymphocytic lymphoma

- Relapsed or refractory to approved therapies, or no viable alternative therapy
available

- ECOG performance status of 0-2

Exclusion Criteria:

- Patients receiving any other agent or therapy to treat their malignancy

- Pre-existing gastrointestinal disorders which may interfere with absorption of drugs

- Clinically significant cardiovascular disease

- Pregnant or lactating women

- HIV-positive patients receiving combination antiretroviral therapy

- Amendment J and onward for patients in the food effect evaluation and for all
subsequent patients if dosing with a high fat/high calorie meal is found to be
optimal: Patients with allergies to any ingredient in the defined liquid supplement
and/or inability to tolerate a high fat/high calorie meal twice daily on scheduled
RO5045337 dosing days

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose/Dose-limiting toxicities

Outcome Time Frame:

approximately 4.5 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

NO21279

NCT ID:

NCT00623870

Start Date:

May 2008

Completion Date:

November 2012

Related Keywords:

  • Hematologic Neoplasms
  • Neoplasms
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Hematologic Neoplasms

Name

Location

Fountain Valley, California  92708
Albany, New York  12208
Austin, Texas  78705
Hackensack, New Jersey  07601