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| Sponsor: | EMD Serono |
|---|---|
| Information provided by (Responsible Party): | EMD Serono |
| ClinicalTrials.gov Identifier: | NCT00957580 |
Purpose
The research trial is testing the experimental drug AS703026 in the treatment of blood and bone marrow cancers. The study will be run in two parts:
Phase 1: Will determine the maximum tolerated dose of the study drug in subjects with advanced hematological malignancies.
Phase II: Will assess the anti-leukemic activity of the study drug in older subjects with newly diagnosed poor prognosis Acute Myeloid Leukemia who are not candidates for intensive chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myeloid Leukemia Hematological Malignancies |
Drug: Mek Inhibitor AS703026 |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial With Safety-Run-In of MEK Inhibitor AS703026 In Subjects With Poor Prognosis Acute Myeloid Leukemia and Other Hematological Malignancies |
| Estimated Enrollment: | 175 |
| Study Start Date: | August 2009 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Phase 1: Regimen 1, Regimen 2, Regimen 3
Phase 1, Regimen 1 : subjects will be dosed orally twice daily on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. Phase 1, Regimen 2: subjects will be dosed orally twice daily on Days 1 to 21 of a 28-day cycle. Phase I, Regimen 3: Regimen 3 subjects will be orally dosed twice daily on Days 1-28 of a 28-day cycle. |
Drug: Mek Inhibitor AS703026
Phase 1: The starting dose AS703026 will be 8 mg orally BID. The dose escalation will proceed separately for both regimens until Maximum Tolerated Dose (MTD) is reached. Regimen 1: Day 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of a 28 day cycle Regimen 2: Days 1 to 21 of a 28 day cycle Regimen 3: Days 1 to 28 of a 28 day cycle Number of Cycles: At least one 28-day cycle. The treatment will be continued until disease progression, intolerable toxicity, or Investigator/subject decision. |
|
Experimental: Phase 2: Regimen 1, Regimen 2
Phase 2, Regimen 1: Regimen 1 subjects will be dosed orally twice daily on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. Phase 2, Regimen 2: Regimen 2 subjects will be dosed orally twice daily on days 1 to 21 of a 28-day cycle. |
Drug: Mek Inhibitor AS703026
Phase 2: Dose is determined by Part 1 of the trial (could be the MTD or lower dose level). Regimen 1: Day 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of a 28 day cycle Regimen 2: Days 1 to 21 of a 28 day cycle Number of Cycles: At least one 28-day cycle. The treatment will be continued until disease progression, intolerable toxicity, or Investigator/subject decision. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Phase 1:
Subjects with one of the following conditions:
Phase 2:
Subjects meet at least one of the following conditions:
Age greater than or equal to 60 and less than 75 years with at least one of the following poor prognostic factors:
Exclusion Criteria:
Phase 1 and Phase 2:
Contacts and Locations| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
| Baltimore, Maryland, United States | |
| Contact: Janet Briel, Program Manager 410-614-5068 jbriel1@jhmi.edu | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States | |
| Contact: Ilene Galinsky, APRN-C 617-632-6524 igalinsky@partners.org | |
| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States | |
| Contact: Monica Kwari 713-794-1557 mkwari@mdanderson.org | |
| France | |
| Hospital Edouard Herriot, Service d'Hematologie Clinique | Recruiting |
| Lyon Cedex, France | |
| Contact: Xavier Thomas, MD +33 (0) 4 72 11 73 24 xavier.thomas@chu-lyon.fr | |
| Hospital Hotel Dieu, Service D'Hematologie | Recruiting |
| Nantes, France | |
| Contact: Jean-Luc Harousseau + 33 (0) 2 40 67 99 80 jl-harousseau@nantes.fnctcc.fr | |
| Hospital Saint Louis, Service D'Hematologie | Recruiting |
| Paris, France | |
| Contact: Herve Dombret, MD +33 (0) 1 42 49 96 43 herve.dombret@sls.aphp.fr | |
| CHU du Haut-Leveque, Service des Matadies du Sang Unite de Recherche Clinique | Recruiting |
| Pessac, France | |
| Contact: Amaud Pigneux, MD + 33 (0) 2 40 67 99 80 amaud.pigneux@chu-bordeaux.fr | |
| Study Director: | Ekaterine Asatiani, MD | Merck Serono S.A., Geneva |
More Information
| Responsible Party: | EMD Serono |
| ClinicalTrials.gov Identifier: | NCT00957580 History of Changes |
| Other Study ID Numbers: | EMR200066_002 |
| Study First Received: | August 11, 2009 |
| Last Updated: | October 25, 2011 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency; United States: Food and Drug Administration |
|
Mek Inhibitor Acute Myeloid Leukemia Hematological Malignancies Elderly Patients Phase II |
|
Neoplasms Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid |
Hematologic Neoplasms Neoplasms by Histologic Type Neoplasms by Site Hematologic Diseases |