Trial of Pimasertib in Hematological Malignancies

PHASE2TerminatedINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2012

Conditions
Leukemia, Myeloid, AcuteHematologic Neoplasms
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (9)

Unknown

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

Sponsors

Lead Sponsor

All Listed Sponsors
lead

EMD Serono

INDUSTRY

NCT00957580 - Trial of Pimasertib in Hematological Malignancies | Biotech Hunter | Biotech Hunter