NCT01641250

Brief Summary

This multi-center, open-label study will evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of RO5429083 alone and in combination with cytarabine in patients with acute myelogenous leukemia. In Part A, patients will receive multiple escalating doses of RO5429083 intravenously. In Part B, patients will receive RO5429083 plus up to 4 cycles of cytarabine (1000 mg/m2 iv daily for 5 consecutive days). Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2012

Typical duration for phase_1

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2012

Completed
16 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2.5 years

First QC Date

July 12, 2012

Last Update Submit

November 1, 2016

Conditions

Myelogenous Leukemia, Acute

Outcome Measures

Primary Outcomes (1)

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

    approximately 24 months

Secondary Outcomes (4)

  • Clinical response according to hematologic malignancy assessments

    approximately 24 months

  • Pharmacokinetics o RO5429083 alone and in combination with cytarabine: Area under the concentration-time curve (AUC)

    Pre-dose and up to 96 hrs post-dose

  • Pharmacokinetics of cytarabine in combination with RO5429083: Area under the concentration-time curve (AUC)

    Pre-dose and up to 24 hrs post-dose, Cycles 1 and 3

  • Pharmacodynamics: Biomarker levels in blood/bone marrow

    Pre-dose and up to 96 hrs post-dose

Study Arms (2)

Part A: RO5429083

EXPERIMENTAL
Drug: RO5429083

Part B: RO5429083 + cytarabine

EXPERIMENTAL
Drug: RO5429083Drug: cytarabine

Interventions

RO5429083DRUG

Multiple escalating doses

Part A: RO5429083Part B: RO5429083 + cytarabine
cytarabineDRUG

1000 mg/m2 iv daily for 5 consecutive days, up to 4 cycles

Part B: RO5429083 + cytarabine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Marseille, 13273, France

Location

Unknown Facility

Nantes, 44093, France

Location

Unknown Facility

Paris, 75475, France

Location

Unknown Facility

Toulouse, 31059, France

Location

Unknown Facility

Aachen, 52074, Germany

Location

Unknown Facility

Hamburg, 20246, Germany

Location

Unknown Facility

Ulm, 89081, Germany

Location

Unknown Facility

Bologna, Emilia-Romagna, 40138, Italy

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2012

First Posted

July 16, 2012

Study Start

August 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

FR(4)DE(3)IT(1)