A Study of RO5045337 [RG7112] in Patients With Hematologic Neoplasms.

Phase 1

Completed

• Conditions: Hematologic Neoplasms
• Interventions: Drug: RO5045337

• Registration Number: NCT00623870
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2008-02-18
• Study First Submitted QC: 2008-02-18
• Study First Posted: 2008-02-26
• Study Start: 2008-05
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	RO5045337	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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