A Study of RO5045337 [RG7112] in Patients With Hematologic Neoplasms. - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00623870

Purpose

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.

Condition	Intervention	Phase
Hematologic Neoplasms	Drug: RO5045337	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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)

Resource links provided by NLM:

Genetics Home Reference related topics: familial acute myeloid leukemia with mutated CEBPA

MedlinePlus related topics: Acute Lymphocytic Leukemia Cancer Chronic Lymphocytic Leukemia Leukemia Lymphoma

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Maximum tolerated dose/Dose-limiting toxicities [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
Safety: Incidence of adverse events [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
Comparison of daily versus twice daily dosing: Incidence of adverse events [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Clinical response: Clinical/hematologic malignancy assessments [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	140
Study Start Date:	May 2008
Estimated Study Completion Date:	March 2013

Arms	Assigned Interventions
Experimental: 1	Drug: RO5045337 Multiple ascending doses

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623870

Contacts

Contact: Please reference Study ID Number: NO21279

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Locations

United States, California
	Completed
Duarte, California, United States, 91010
United States, New Jersey
	Active, not recruiting
New Brunswick, New Jersey, United States, 08901
United States, New York
	Completed
New York, New York, United States, 10065
United States, Texas
	Completed
Houston, Texas, United States, 77030
	Completed
San Antonio, Texas, United States, 78229
Canada, Ontario
	Active, not recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
	Completed
Montreal, Quebec, Canada, H3T IE2
Italy
	Recruiting
Bologna, Italy, 40138
	Completed
Roma, Italy, 00161
United Kingdom
	Recruiting
Glasgow, United Kingdom, G12 0YN
	Active, not recruiting
Leeds, United Kingdom, LS9 7TF
	Not yet recruiting
Oxford, United Kingdom, OX3 7LJ

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00623870 History of Changes
Other Study ID Numbers:	NO21279
Study First Received:	February 18, 2008
Last Updated:	May 21, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Hematologic Neoplasms
Leukemia, B-Cell
Leukemia

Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Neoplasms by Site

ClinicalTrials.gov processed this record on May 22, 2012