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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00623870
First received: February 18, 2008
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

This study will determine the maximum tolerated dose of RO5045337 and the optima l 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 c ycle. 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 b e 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:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]
  • Maximum tolerated dose/Dose-limiting toxicities [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]
  • 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 ]

Enrollment: 116
Study Start Date: May 2008
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Italy
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
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00623870     History of Changes
Other Study ID Numbers: NO21279
Study First Received: February 18, 2008
Last Updated: October 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hematologic Neoplasms
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Acute
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Leukemia
Leukemia, Myeloid
Myeloproliferative Disorders
Neoplasms by Histologic Type
Neoplasms by Site

ClinicalTrials.gov processed this record on October 30, 2014