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Sponsors and Collaborators: |
University of Bologna Janssen-Cilag Ltd. |
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Information provided by: | University of Bologna |
ClinicalTrials.gov Identifier: | NCT00510939 |
This is one of the first studies of combination of Zarnestra plus Velcade in man. A primary objective of the study is therefore to assess the safety and tolerability of multiple doses of Zarnestra plus Velcade in patients with AML.
New treatments for patients that are untreatable with intensive chemotherapy aged de novo AML patients or post-relapse AML are urgently required since, at present, many of the drugs used for second line therapy are the same as those used for first induction and response rates are much lower.
In Part B additional patients with AML will be treated to further characterize the tolerability,biological effects, and clinical efficacy of the combination Velcade plus Zarnestra. Patients on treatment for AML will undergo regular bone marrow aspirates and biopsies to assess responses to treatment. This will facilitate frequent assessment of biological endpoints (reduction in expression and phosphorylation of IKKb kinase, and downstream markers of signalling along with apoptosis, survival, proliferation and cellular size and ploidy) will be made in an attempt to confirm that the desired biological activity has been achieved at the maximum tolerated dose.
Condition | Intervention | Phase |
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Acute Myeloid Leukemia |
Drug: Tipifarnib plus Bortezomib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II, Open-Label, Multi-Centre, 2-Part Study to Assess the Safety, Tolerability, and Efficacy of Tipifarnib Plus Bortezomib in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) Unfit for Conventional Chemotherapy ( >18 Years) or in Patients With Acute Myeloid Leukemia in First Relapse ( >60 Years) |
Estimated Enrollment: | 70 |
Study Start Date: | March 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Giovanni Martinelli, MD | +39 051 6363829 | gmartino@alma.unibo.it |
Italy | |
Istituto di Ematologia "L e A Seragnoli" Policlinico S.Orsola-Malpighi | Recruiting |
Bologna, Italy, 40138 | |
Contact: Giovanni Martinelli, MD +039 051 6363829 martg@tin.it |
Principal Investigator: | Giovanni Martinelli, MD | Istituto di Ematologia ed Oncologia Medica "L.eA.Seràgnoli" Policlinico S.Orsola-Malpighi di Bologna |
Responsible Party: | Dipartimento di Ematologia "Seragnoli"- Policlinico Sant'Orsola Bologna ( Giovanni Martinelli ) |
Study ID Numbers: | HEMOS AML 0106, EudraCT 2007-000273-35 |
Study First Received: | August 2, 2007 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00510939 |
Health Authority: | Italy: The Italian Medicines Agency; Italy: Ethics Committee |
Acute myeloid leukemia NFkB activity and leukemia expression of NFkB |
Leukemia Bortezomib Acute myelogenous leukemia Leukemia, Myeloid |
Leukemia, Myeloid, Acute Acute myelocytic leukemia Tipifarnib |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |