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

This study has been terminated.
(Material sponsor withdrew support)
Sponsor:
Collaborators:
The Leukemia and Lymphoma Society
Pfizer
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01701375
First received: September 11, 2012
Last updated: August 30, 2013
Last verified: August 2013
Results First Received: June 14, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Relapsed Acute Leukemia
Refractory Acute Leukemia
High-Risk Myelodysplasia
Intervention: Drug: PD 0332991

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
2 subjects were accrued

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm 1
  • PD 0332991 125 was given orally days 1,2,3
  • Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6
  • Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose

Participant Flow:   Overall Study
    Arm 1  
STARTED     2  
COMPLETED     2  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm 1
  • PD 0332991 will be given orally days 1,2,3
  • Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6
  • Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose

Baseline Measures
    Arm 1  
Number of Participants  
[units: participants]
  2  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     2  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  45.5  ± 27  
Gender  
[units: participants]
 
Female     1  
Male     1  
Region of Enrollment  
[units: participants]
 
United States     2  



  Outcome Measures

1.  Primary:   The Toxicities of Administration of PD 0332991 in Combination With Cytarabine and Mitoxantrone.   [ Time Frame: 42 days ]
  Hide Outcome Measure 1

Measure Type Primary
Measure Title The Toxicities of Administration of PD 0332991 in Combination With Cytarabine and Mitoxantrone.
Measure Description The number of participants experiencing toxicities of administration of PD 0332991 in combination with cytarabine and mitoxantrone will be measured according to NCI-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time Frame 42 days  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm 1
  • PD 0332991 will be given orally days 1,2,3
  • Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6
  • Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose

Measured Values
    Arm 1  
Number of Participants Analyzed  
[units: participants]
  2  
The Toxicities of Administration of PD 0332991 in Combination With Cytarabine and Mitoxantrone.  
[units: participants]
  2  

No statistical analysis provided for The Toxicities of Administration of PD 0332991 in Combination With Cytarabine and Mitoxantrone.



2.  Secondary:   To Determine the Maximal Tolerated Dose (MTD) of PD 0332991 in Timed Sequential Combination With Ara-C and Mitoxantrone   [ Time Frame: 42 days ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Ivana Gojo, MD
Organization: Johns Hopkins University
phone: 410-502-7726
e-mail: Igojo1@jhmi.edu


No publications provided


Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01701375     History of Changes
Other Study ID Numbers: J1275, NA_00076003
Study First Received: September 11, 2012
Results First Received: June 14, 2013
Last Updated: August 30, 2013
Health Authority: United States: Food and Drug Administration