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Study 20 of 872 for search of: | "Paraproteinemias" |
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Sponsored by: |
Chroma Therapeutics |
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Information provided by: | Chroma Therapeutics |
ClinicalTrials.gov Identifier: | NCT00689000 |
This is an open-label, non-randomised, multi-centre phase I-II study of CHR-2797 administered orally once a day. The study involves two distinct phases:
Condition | Intervention | Phase |
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Acute Myeloid Leukemia Myelodysplastic Syndrome Multiple Myeloma |
Drug: Aminopeptidase inhibitor |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I-II Study to Evaluate the Safety, Tolerability and Anti-Disease Activity of the Aminopeptidase Inhibitor, CHR-2797, in Elderly and/or Treatment Refractory Patients With Acute Myeloid Leukemia or Multiple Myeloma |
Enrollment: | 57 |
Study Start Date: | May 2006 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
oral, once daily administration of CHR-2797 to determine safety & anti-disease activity.
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Drug: Aminopeptidase inhibitor
Phase I: Once daily, oral ingestion of CHR-2797 capsules (60mg, 90mg, 130mg or 180mg) depending on cohort Phase II: Once daily, oral ingestion of 130mg CHR-2797 (recommended dose from Phase I) until progressive disease or withdrawal from the study |
This is an open-label, non-randomised, multi-centre phase I-II study of CHR-2797 administered orally once a day. The study involves two distinct phases:
Phase I: an open-label, dose-escalating phase of the study to explore the safety, tolerability, and pharmacokinetics (PK) of CHR-2797. Cohorts of 3-6 patients each will be treated with escalating, once daily, oral doses of CHR-2797 for 84 days (12 weeks), of which the first 28 days constitute the dose finding/ DLT phase. The starting dose will be 60 mg once daily. Doses will be increased in a stepwise fashion by around 40 percent per step until the MTD is reached. The proportion of patients with Multiple Myeloma will be limited to one third: one per cohort of 3 or 2 per cohort of 6. It is anticipated that 24-30 patients will be enrolled in the phase I portion of the trial. A decision will be made with regard to the disease indication to be tested in phase II (either AML/MDS or MM or both), after completion of phase I, or following definition of MTD.
Phase II: the recommended dose as determined in phase I, will be administered for 84 days to a maximum of 40 patients. The primary objective is to determine whether CHR-2797 has sufficient biological activity against the disease(s) under study. A multinomial stopping rule has been included in the design that incorporates objective responses and early progression into a decision to stop or continue this phase I/II trial. An interim assessment will be performed after 15 patients have received the maximum acceptable dose (MAD) dose of CHR-2797 with clearly defined early stopping rules.
There will be a clinical conference at the end of every cohort in the phase I portion of the study, between phase I and II and after the first 15 patients have completed therapy in phase II.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate bone marrow, hepatic and renal function including the following:
Exclusion Criteria:
United Kingdom, Scotland | |
Nexus Oncology Ltd | |
Edinburgh, Scotland, United Kingdom, EH25 9PP |
Principal Investigator: | Gareth Morgan, MD | Royal Marsden Hospital, UK |
Principal Investigator: | Gert Ossenkoppele, MD | Vrije Universiteit MC, Amsterdam |
Principal Investigator: | Pierre Zachée, MD | ZNA Antwerpen, Belgium |
Principal Investigator: | Alan Burnett, MD | University Hospital, Cardiff, United Kingdom |
Principal Investigator: | Michel Delforge, MD | UZ Gasthuisberg, Leuven, Belgium |
Principal Investigator: | Bob Lowenberg, MD | Erasmus MC, Rotterdam |
Principal Investigator: | Ulrich Dührsen, MD | Universitätsklinikum, Essen, Germany |
Principal Investigator: | Carsten Müller-Tidow, MD | Universitätsklinikum, Münster, Germany |
Responsible Party: | Chroma Therapeutics ( Dr Leon Hooftman, Chief Medical Officer ) |
Study ID Numbers: | CHR-2797-002 |
Study First Received: | May 29, 2008 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00689000 |
Health Authority: | Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Leukemia AML MDS MM Acute Myeloid Leukemia Myelodysplastic Syndrome |
Multiple Myeloma Cancer Hematological malignancies Elderly Refractory Blood |
Myelodysplastic syndromes Immunoproliferative Disorders Precancerous Conditions Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Myelodysplasia Myelodysplastic Syndromes Acute myelogenous leukemia Vascular Diseases Paraproteinemias Leukemia, Myeloid |
Leukemia, Myeloid, Acute Hemostatic Disorders Multiple Myeloma Leukemia Preleukemia Hemorrhagic Disorders Multiple myeloma Bone Marrow Diseases Lymphoproliferative Disorders Acute myelocytic leukemia Neoplasms, Plasma Cell |
Neoplasms Pathologic Processes Disease Neoplasms by Histologic Type |
Immune System Diseases Syndrome Cardiovascular Diseases |