81
Participants
Start Date
September 30, 2009
Primary Completion Date
December 31, 2012
Study Completion Date
December 31, 2012
Pimasertib
Pimasertib will be administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose will be escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) is reached. The treatment will be continued until disease progression, intolerable toxicity, or Investigator/subject decision.
Pimasertib
Pimasertib will be administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose will be escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD is reached. The treatment will be continued until disease progression, intolerable toxicity, or Investigator/subject decision.
Pimasertib
Pimasertib will be administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose escalation will proceed to 75 mg BID until MTD is reached. The treatment will be continued until disease progression, intolerable toxicity, or Investigator/subject decision.
Pimasertib
Pimasertib will be administered orally twice daily on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. Dose will be determined by Part 1 of the trial (could be the MTD or lower dose level). The treatment will be continued until disease progression, intolerable toxicity, or Investigator/subject decision.
Pimasertib
Pimasertib will be administered orally twice daily on Days 1 to 21 of a 28-day cycle. Dose will be determined by Part 1 of the trial (could be the MTD or lower dose level). The treatment will be continued until disease progression, intolerable toxicity, or Investigator/subject decision.
Northwestern University, Chicago
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore
Beth Israel Deaconess Medical Center, Boston
Dana Farber Cancer Institute, Boston
University of Texas - MD Anderson Cancer Center, Houston
Hospital Hotel Dieu, Service D'Hematologie, Nantes
Hospital Edouard Herriot, Service d'Hematologie Clinique, Lyon
Hospital Saint Louis, Service des Maladies du Sang, Paris
CHU du Haut-Leveque, Service des Maladies du Sang Unite de Recherche Clinique, Pessac
Lead Sponsor
EMD Serono
INDUSTRY