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 ]

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 reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events
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Time Frame No text entered.
Additional Description 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

Serious Adverse Events
    Arm 1  
Total, serious adverse events    
# participants affected / at risk     1/2 (50.00%)  
Blood and lymphatic system disorders    
Bone marrow aplasia † 2  
# participants affected / at risk     1/2 (50.00%)  
# events     1  
Metabolism and nutrition disorders    
Hyperbilirubinemia † 1  
# participants affected / at risk     1/2 (50.00%)  
# events     1  
Events were collected by systematic assessment
1 Term from vocabulary, 10005364
2 Term from vocabulary, 10048580




  Other Adverse Events


  Limitations and Caveats
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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.


  More Information