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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00623870
Recruitment Status : Completed
First Posted : February 26, 2008
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hematologic Neoplasms Drug: RO5045337 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : May 2008
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Arm Intervention/treatment
Experimental: 1 Drug: RO5045337
Multiple ascending doses

Primary Outcome Measures :
  1. Maximum tolerated dose/Dose-limiting toxicities [ Time Frame: approximately 4.5 years ]
  2. Safety: Incidence of adverse events [ Time Frame: approximately 4.5 years ]
  3. Comparison of daily versus twice daily dosing: Incidence of adverse events [ Time Frame: approximately 4.5 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Clinical response: Clinical/hematologic malignancy assessments [ Time Frame: approximately 4.5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00623870

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United States, California
Duarte, California, United States, 91010
United States, New Jersey
New Brunswick, New Jersey, United States, 08901
United States, New York
New York, New York, United States, 10065
United States, Texas
Houston, Texas, United States, 77030
Canada, Ontario
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Montreal, Quebec, Canada, H3T 1E2
Bologna, Emilia-Romagna, Italy, 40138
Roma, Lazio, Italy, 00161
United Kingdom
Glasgow, United Kingdom, G12 0YN
Leeds, United Kingdom, LS9 7TF
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche Identifier: NCT00623870    
Other Study ID Numbers: NO21279
First Posted: February 26, 2008    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases