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| 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 po, 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. The anticipated time on study treatment is until disease progression or intolerable toxicity.
| Condition | Intervention | Phase |
|---|---|---|
|
Hematologic Neoplasms |
Drug: RO5045337 |
Phase I |
| 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 R7112 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) |
| Estimated Enrollment: | 140 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | January 2013 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: RO5045337
20mg/m2 (starting dose)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Please reference Study ID Number: NO21279 | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
| 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 | |
| Active, not recruiting | |
| Houston, Texas, United States, 77030 | |
| Completed | |
| San Antonio, Texas, United States, 78229 | |
| Canada, Ontario | |
| Not yet recruiting | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Canada, Quebec | |
| Not yet recruiting | |
| Montreal, Quebec, Canada, H3T IE2 | |
| Italy | |
| Not yet recruiting | |
| Bologna, Italy, 40138 | |
| Completed | |
| Roma, Italy, 00161 | |
| United Kingdom | |
| Not yet recruiting | |
| Glasgow, United Kingdom, G12 0YN | |
| Recruiting | |
| Leeds, United Kingdom, LS9 7TF | |
| Not yet recruiting | |
| Oxford, United Kingdom, OX3 7LJ | |
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
| 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: | October 14, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
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 |