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PD0332991 (Palbociclib) in Patients With Advanced or Metastatic Liposarcoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01209598
First Posted: September 27, 2010
Last Update Posted: November 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
Results First Submitted: September 8, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Sarcoma
Liposarcoma
Interventions: Drug: Palbociclib 200mg
Drug: Palbociclib 125mg

  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
Protocol Open to Accrual 09/23/2010 Protocol Closed to Accrual 05/27/2014 Primary Completion Date 10/25/2016 Recruitment Location is the medical clinic

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
Palbociclib 200mg

This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks.

Palbociclib 200mg: Schedule 2/1: Palbociclib 200mg given once daily by mouth for 14 consecutive days, followed by 7 days of rest. A cycle will be defined as 21 days.

Palbociclib 125mg

This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks.

Palbociclib 125mg: Schedule 3/1: Palbociclib 125mg given once daily by mouth for 21 consecutive days, followed by 7 days of rest. A cycle will be defined as 28 days. Following the positive results of the study, a new Expansion Cohort has been added to permit enrollment of up to 20 additional patients.


Participant Flow:   Overall Study
    Palbociclib 200mg   Palbociclib 125mg
STARTED   30   60 
COMPLETED   29   60 
NOT COMPLETED   1   0 
Withdrawal by Subject                1                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
Palbociclib 200mg

This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks.

Palbociclib 200mg: Schedule 2/1: Palbociclib 200mg given once daily by mouth for 14 consecutive days, followed by 7 days of rest. A cycle will be defined as 21 days.

Palbociclib 125mg

This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks.

Palbociclib 125mg: Schedule 3/1: Palbociclib 125mg given once daily by mouth for 21 consecutive days, followed by 7 days of rest. A cycle will be defined as 28 days. Following the positive results of the study, a new Expansion Cohort has been added to permit enrollment of up to 20 additional patients.

Total Total of all reporting groups

Baseline Measures
   Palbociclib 200mg   Palbociclib 125mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   60   90 
Age 
[Units: Years]
Median (Full Range)
 65 
 (37 to 83) 
 61.5 
 (35 to 87) 
 62 
 (35 to 92) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      16  53.3%      31  51.7%      47  52.2% 
Male      14  46.7%      29  48.3%      43  47.8% 
Region of Enrollment 
[Units: Participants]
     
United States   30   60   90 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression Free Survival at 12 Weeks   [ Time Frame: 12 weeks ]

2.  Secondary:   Best Response   [ Time Frame: 2 years ]


  Serious Adverse Events


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


Results Point of Contact:  
Name/Title: Mark Dickson, MD
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-888-4164
e-mail: dicksonm@mskcc.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01209598     History of Changes
Other Study ID Numbers: 10-094
First Submitted: September 24, 2010
First Posted: September 27, 2010
Results First Submitted: September 8, 2017
Results First Posted: November 2, 2017
Last Update Posted: November 2, 2017