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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

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ClinicalTrials.gov Identifier: NCT01701375
Recruitment Status : Terminated (Material sponsor withdrew support)
First Posted : October 5, 2012
Results First Posted : September 9, 2013
Last Update Posted : September 9, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Relapsed Acute Leukemia
Refractory Acute Leukemia
High-Risk Myelodysplasia
Intervention: Drug: PD 0332991

  Participant Flow


  Baseline Characteristics

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 
Overall Participants Analyzed 
[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.  


  Serious Adverse Events


  Other Adverse Events


  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
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  More Information