NCT01701375

A Phase 1 Trial of TST of PD 0332991 Followed by Cytarabine and Mitoxantrone for Adults With Relapsed and Refractory Acute Leukemias and High-Risk Myelodysplasia

A Phase I and Pharmacodynamic Trial of Timed Sequential Administration of the Cyclin Dependent Kinase 4/6 Inhibitor PD 0332991 Followed by Cytarabine Plus Mitoxantrone for Adults With Relapsed and Refractory Acute Leukemias and High-Risk Myelodysplasias

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

1.1 Primary Objectives * To determine the feasibility, tolerability, and toxicities of administering the selective CDK 4/6 inhibitor PD 0332991 prior to the combination of ara-C and Mitoxantrone for adults with relapsed and refractory acute leukemias and high risk myelodysplasias (MDS), including primary refractory disease * To determine the direct cytotoxic effects of single agent PD 0332991 on malignant blasts * To determine the maximal tolerated dose (MTD) of PD 0332991 in timed sequential combination with ara-C and Mitoxantrone * To determine if the timed sequential combination of PD 0332991 with ara-C and mitoxantrone can induce clinical responses in adults with relapsed or refractory acute leukemias and high-risk MDS 1.2 Secondary Objectives: * To determine the ability of PD 0332991 to directly induce apoptosis in malignant cell populations in vivo * To obtain pharmacodynamic (PD) data regarding the ability of PD 0332991 to arrest malignant cells in the G 1 phase of cell cycle, followed by synchronized release of those cells into S phase upon discontinuation of PD 0332991 and resultant enhanced ara-C cytotoxicity

Conditions

• Relapsed Acute Leukemia
• Refractory Acute Leukemia
• High-Risk Myelodysplasia

Interventions

Type	Name	Description
DRUG	PD 0332991	• PD 0332991 will be given orally days 1,2,3

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2012-10-05
• Last updated: 2013-09-09
• Results posted: 2013-09-09

Locations

2 sites across 1 country: United States