or
forgot password

A Multi-Center, Open-Label, Phase 1/1B Study of Escalating Doses of RO5503781 Administered Orally as a Single Agent or in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia (AML)


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

Thank you

Trial Information

A Multi-Center, Open-Label, Phase 1/1B Study of Escalating Doses of RO5503781 Administered Orally as a Single Agent or in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia (AML)


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- Documented acute myelogenous leukemia (AML), except for acute promyelocytic leukemia

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 in Part 1 and
Part 2, patients enrolled in the extension/tail portion must have an ECOG performance
status of 0 or 1

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

- Willing to submit the blood sampling and bone marrow sampling required by protocol

Exclusion Criteria:

- Patients receiving any other investigational or commercial agents or therapies
administered with the intention to treat their malignancy within 14 days of first
receipt of study drug, with the exception of hydroxyurea as defined in protocol

- History of allergic or toxic reactions attributed to cytarabine (Part 2) or history
of allergic reactions to components of the formulated product

- Current evidence of central nervous system (CNS) leukemia

- Patients with severe and/or uncontrolled medical conditions or other conditions that
could affect their participation in the study

- Patients with evidence of electrolyte imbalance of Grade >/= 2 which cannot be
corrected prior to study initiation

- Pregnant or breastfeeding women

- HIV-positive patients receiving anti-retroviral therapy

- Patients who refuse to potentially receive blood products and/or have a
hypersensitivity to blood products

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum tolerated dose (MTD)

Outcome Time Frame:

approximately 1.5 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Canada: Health Canada

Study ID:

NP28679

NCT ID:

NCT01773408

Start Date:

February 2013

Completion Date:

August 2014

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