A Study of RO5045337 [RG7112] in Patients With Hematologic Neoplasms.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00623870
First received: February 18, 2008
Last updated: May 7, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
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 ]
| Enrollment: | 116 |
| Study Start Date: | May 2008 |
| 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
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 | |
| San Antonio, Texas, United States, 78229 | |
| Canada, Ontario | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Canada, Quebec | |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Italy | |
| Bologna, Italy, 40138 | |
| Roma, 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: | May 7, 2013 |
| 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 19, 2013