NCT00798213 (Clinical Trial / Gemtuzumab Ozogamicin)

Study Title
SCH 727965 in Patients With Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia (P04717AM2)(TERMINATED) (NCT00798213)

Trial Description
Participants with acute myelogenous leukemia (AML) will be randomized to Dinacyclib (SCH 727965), a novel and potent cyclin-dependent kinase inhibitor*, or the antibody-drug conjugate gemtuzumab ozogamicin (Mylotarg®; Pfizer/Wyeth-Ayerst Laboratories).

All participants with acute lymphoblastic leukemia (ALL) will receive Dinacyclib (SCH 727965). Part 1 of the study will determine the activity of Dinacyclib (SCH 727965) treatment in participants with AML and participants with ALL. Part 2 of the study will determine the activity of Dinacyclib (SCH 727965) treatment in participants with AML who experienced disease progression after standard treatment with gemtuzumab ozogamicin during Part 1.

This trial is sponsored by Merck Sharp & Dohme Corp. [1]

Study Data

  • Condition:
    • Acute Myeloid Leukemia (AML)
    • Acute Lymphoblastic Leukemia (ALL)
  • Interventions:
  • Phase: II
  • Enrollment: 29
  • Start: January 2009
  • Completion: April 2010.
  • Last verified: February 2015

Study Schematic

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* Cyclin-dependent kinases (CDK) are key positive regulators of cell cycle progression and attractive targets in oncology. Dinacyclib (SCH 727965),  a pyrazolo[1,5-a]pyrimidine with potential antineoplastic activity selectively inhibits cyclin dependent kinases CDK1, CDK2, CDK5, and CDK9; inhibition of CDK1 and CDK2 and may result in cell cycle repression and tumor cell apoptosis.

Last Editorial review: July 21, 2015
Information based on (NIH/NCI) and other sources.

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