NCT00623870

Brief Summary

This study will determine the maximum tolerated dose of RO5045337 and the optimal associated 4 weekly dosing schedule of RO5045337, administered as monotherapy in patients with hematologic neoplasms. A first cohort of patients will receive the starting dose of 20mg/m2/day orally, once daily for 10 days in each 28 day cycle. Subsequent cohorts of patients will receive dose escalations, and possible changes in dosing schedule, based on tolerability and pharmacokinetic knowledge gained from prior treatment cohorts. Different formulations of RO5045337 will be tested and the food effect evaluated. The anticipated time on study treatment is until disease progression or intolerable toxicity.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2008

Longer than P75 for phase_1

Geographic Reach
4 countries

11 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

February 18, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 26, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

4.5 years

First QC Date

February 18, 2008

Last Update Submit

November 1, 2016

Conditions

Hematologic Neoplasms

Outcome Measures

Primary Outcomes (3)

  • Maximum tolerated dose/Dose-limiting toxicities

    approximately 4.5 years

  • Safety: Incidence of adverse events

    approximately 4.5 years

  • Comparison of daily versus twice daily dosing: Incidence of adverse events

    approximately 4.5 years

Secondary Outcomes (3)

  • Pharmacokinetics: Blood/Urine concentrations

    Pre- and post-dose multiple sampling Days 1+2/Days 1+10 Cycle 1, post-dose sampling Days 11+15 Cycle 1, pre-dose Days 1+2 Cycle 2

  • Pharmacodynamics: Blood leukemia cells/MIC-1 protein level/CD33+CD34 markers

    Pre- and post-dose Days 1+10 Cycle 1, pre-dose Day 2 Cycle 1, Days 1+2 Cycle 2

  • Clinical response: Clinical/hematologic malignancy assessments

    approximately 4.5 years

Study Arms (1)

1

EXPERIMENTAL
Drug: RO5045337

Interventions

RO5045337DRUG

Multiple ascending doses

1

Eligibility Criteria

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

You may qualify if:

  • Adult patients, \>=18 years of age
  • Acute myeloid leukemia, acute lymphocytic leukemia, chronic myelogenous leukemia in blast phase, refractory chronic lymphocytic leukemia/small cell lymphocytic lymphoma
  • Relapsed or refractory to approved therapies, or no viable alternative therapy available
  • ECOG performance status of 0-2

You may not qualify if:

  • Patients receiving any other agent or therapy to treat their malignancy
  • Pre-existing gastrointestinal disorders which may interfere with absorption of drugs
  • Clinically significant cardiovascular disease
  • Pregnant or lactating women
  • HIV-positive patients receiving combination antiretroviral therapy
  • Amendment J and onward for patients in the food effect evaluation and for all subsequent patients if dosing with a high fat/high calorie meal is found to be optimal: Patients with allergies to any ingredient in the defined liquid supplement and/or inability to tolerate a high fat/high calorie meal twice daily on scheduled RO5045337 dosing days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Duarte, California, 91010, United States

Location

Unknown Facility

New Brunswick, New Jersey, 08901, United States

Location

Unknown Facility

New York, New York, 10065, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Toronto, Ontario, M5G 2M9, Canada

Location

Unknown Facility

Montreal, Quebec, H3T 1E2, Canada

Location

Unknown Facility

Bologna, Emilia-Romagna, 40138, Italy

Location

Unknown Facility

Rome, Lazio, 00161, Italy

Location

Unknown Facility

Glasgow, G12 0YN, United Kingdom

Location

Unknown Facility

Leeds, LS9 7TF, United Kingdom

Location

Unknown Facility

Oxford, OX3 7LJ, United Kingdom

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 18, 2008

First Posted

February 26, 2008

Study Start

May 1, 2008

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

CA(2)US(4)IT(2)GB(3)