Back to resultsA Study of RO5045337 [RG7112] in Patients With Hematologic Neoplasms.
Primary Purpose
Hematologic Neoplasms
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
RO5045337
Sponsored by
About this trial
This is an interventional treatment trial for Hematologic Neoplasms
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Maximum tolerated dose/Dose-limiting toxicities
Safety: Incidence of adverse events
Comparison of daily versus twice daily dosing: Incidence of adverse events
Secondary Outcome Measures
Pharmacokinetics: Blood/Urine concentrations
Pharmacodynamics: Blood leukemia cells/MIC-1 protein level/CD33+CD34 markers
Clinical response: Clinical/hematologic malignancy assessments
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00623870
Brief Title
A Study of RO5045337 [RG7112] in Patients With Hematologic Neoplasms.
Official Title
An Open Label Study to Investigate the Maximum Tolerated Dose of RO5045337 in Patients With Acute Myelogenous Leukemia (AML), Acute Lymphocytic Leukemia (ALL), Chronic Myelogenous Leukemia (CML) in Blast Phase, or Refractory Chronic Lymphocytic Leukemia/Small Cell Lymphocytic Lymphoma (CLL / SCLL)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
RO5045337
Intervention Description
Multiple ascending doses
Primary Outcome Measure Information:
Title
Maximum tolerated dose/Dose-limiting toxicities
Time Frame
approximately 4.5 years
Title
Safety: Incidence of adverse events
Time Frame
approximately 4.5 years
Title
Comparison of daily versus twice daily dosing: Incidence of adverse events
Time Frame
approximately 4.5 years
Secondary Outcome Measure Information:
Title
Pharmacokinetics: Blood/Urine concentrations
Time Frame
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
Title
Pharmacodynamics: Blood leukemia cells/MIC-1 protein level/CD33+CD34 markers
Time Frame
Pre- and post-dose Days 1+10 Cycle 1, pre-dose Day 2 Cycle 1, Days 1+2 Cycle 2
Title
Clinical response: Clinical/hematologic malignancy assessments
Time Frame
approximately 4.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
City
Roma
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of RO5045337 [RG7112] in Patients With Hematologic Neoplasms.
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