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Open Label, Multicenter, Dose Escalation Phase 1a/b Study of RO5429083, Administered as Intravenous Infusion Alone or in Combination With Cytarabine 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

Open Label, Multicenter, Dose Escalation Phase 1a/b Study of RO5429083, Administered as Intravenous Infusion Alone or in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia (AML).


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- Histologically or cytologically confirmed, acute myelogenous leukemia (all subtypes
except acute promyelotic leukemia) according to WHO criteria

- 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 < 2, except alopecia

- Adequate hepatic and renal function

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

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

- History of allergic reactions attributed to components of cytarabine and/or the
formulated product

- Current evidence of CNS leukemia

- Increased QTc interval (QTc > 470 ms), baseline resting bradycardia < 45 beats per
minute, or baseline resting tachycardia < 100 beats per minute

- Family history of long QT syndrome or other risk factors for torsades de pointes,
and/or the use of concomitant medications that prolong QT/QTc interval

- Uncontrollable intercurrent illness

- Pregnant or breast-feeding 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:

Safety: Incidence of adverse events (including maximum tolerated dose/optimal biological dose)

Outcome Time Frame:

approximately 24 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

France: Agence Francaise de Secrurite Sanitaire des Produits de Sante

Study ID:

BP28085

NCT ID:

NCT01641250

Start Date:

August 2012

Completion Date:

February 2015

Related Keywords:

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

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