A Study of RO5503781 as a Single Agent or in Combination With Cytarabine in Participants With Acute Myelogenous Leukemia

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Roche

Status and phase

Completed
Phase 1

Conditions

Myelogenous Leukemia, Acute

Treatments

Drug: Daunorubicin
Drug: Idarubicin
Drug: RO5503781 SDP
Drug: Cytarabine
Drug: RO5503781 MBP

Study type

Interventional

Funder types

Industry

Identifiers

NCT01773408
2012-004882-41 (EudraCT Number)
NP28679

Details and patient eligibility

About

This Phase 1/1b, open-label study will evaluate the safety and pharmacokinetics of escalating doses of RO5503781 as a single agent or in combination with cytarabine in participants with acute myelogenous leukemia. In Part 1, RO5503781 will be administered in escalating doses as a single agent, and in Part 2, RO5503781 will be administered in combination with cytarabine. An optional Part 3 in which RO5503781 will be administered with cytarabine and anthracycline may be considered . In Part 4, the safety and pharmacokinetic profile of an optimized formulation of RO5503781 in combination with cytarabine will be assessed.

Enrollment

122 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Documented/confirmed 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, participants enrolled in the extension/tail portion, Part 3 and Part 4 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 National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade less than or equal to (</=) 2 prior to starting therapy
  • Adequate hepatic and renal function
  • Willing to submit the blood sampling and bone marrow sampling required by protocol

Additional inclusion criteria for Parts 1-4 may apply.

Exclusion criteria

  • Participants 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
  • Participants with severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
  • Participants with evidence of electrolyte imbalance greater than or equal to (>/=) Grade 2 which cannot be corrected prior to study initiation
  • Pregnant or breastfeeding women
  • Human immunodeficiency virus (HIV) - positive participants receiving anti-retroviral therapy
  • Participants who refuse to potentially receive blood products and/or have a hypersensitivity to blood products

Additional exclusion criteria for Parts 1-4 may apply.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

122 participants in 4 patient groups

Part 1: RO5503781
Experimental group
Description:
Participants will receive RO5503781 alone in escalating doses on Days 1 to 5 of each 28-day cycle until disease progression or unacceptable toxicity.
Treatment:
Drug: RO5503781 MBP
Part 2: RO5503781 + Cytarabine
Experimental group
Description:
Participants will receive RO5503781 in escalating doses on Days 1 to 5 and cytarabine on Days 1 to 6 of each 28-day cycle until disease progression or unacceptable toxicity.
Treatment:
Drug: RO5503781 MBP
Drug: Cytarabine
Part3:RO5503781+Cytarabine+Anthracycline
Experimental group
Description:
Participants will receive RO5503781 on Days 1 to 5, cytarabine on Days 1 to 7, and anthracycline (daunorubicin or idarubicin) on Days 1 to 3 of each 28-day cycle until disease progression or unacceptable toxicity.
Treatment:
Drug: RO5503781 MBP
Drug: Cytarabine
Drug: Idarubicin
Drug: Daunorubicin
Part 4: Optimized RO5503781 + Cytarabine
Experimental group
Description:
Participants will receive optimized RO5503781 formulation on Days 1 to 5 and cytarabine on Days 1 to 6 of each 28-day cycle until disease progression or unacceptable toxicity.
Treatment:
Drug: Cytarabine
Drug: RO5503781 SDP

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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