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A Multicenter, Open Label, Phase 1B Study of Escalating Doses of RO5045337 Administered Orally, With Cytarabine Administered A) Subcutaneously, or B) Intravenously, in Patients With Acute Myelogenous Leukemia (AML)


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Myelogenous Leukemia, Acute

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Trial Information

A Multicenter, Open Label, Phase 1B Study of Escalating Doses of RO5045337 Administered Orally, With Cytarabine Administered A) Subcutaneously, or B) Intravenously, in Patients With Acute Myelogenous Leukemia (AML)


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- Patients with histologically or cytologically documented acute myelogenous leukemia
appropriate for cytarabine therapy including:

- Arm A: Patients who have not received prior standard induction chemotherapy,
considered unsuitable for standard induction therapy

- Arm B: Patients who have failed their 1st or greater line of standard induction
chemotherapy (primary refractory) or patients who originally achieved a complete
response but are currently in first or greater relapse

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

- All non-hematological adverse events of any prior chemotherapy, surgery, or
radiotherapy must have resolved to NCI-CTC AE Grade
- Adequate hepatic and renal function

- Patient must be willing to submit the blood sampling and bone marrow sampling for PK
and PD analyses and exploratory biomarkers

Exclusion Criteria:

- History of allergic or toxic reactions attributed to cytarabine or a history of
allergic reactions to components of the formulated product

- Current evidence of CNS leukemia

- Any severe and/or uncontrolled medical condition or other conditions that could
affect the participation in the study

- Pregnant or breastfeeding women

- HIV-positive patients receiving combination anti-retroviral therapy

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 12 months

Safety Issue:

Yes

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

France: Ministry of Health

Study ID:

NP28023

NCT ID:

NCT01635296

Start Date:

July 2012

Completion Date:

September 2013

Related Keywords:

  • Myelogenous Leukemia, Acute
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Acute Disease

Name

Location

Albany, New York  12208
Philadelphia, Pennsylvania  19104
Austin, Texas  78705