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Study of Pazopanib and Ixabepilone in Patients With Solid Tumors

This study has been terminated.
(PI left institution.)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT01012362
First received: November 12, 2009
Last updated: April 11, 2017
Last verified: January 2016
Results First Received: April 11, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Prevention
Conditions: Breast Cancer
Lung Cancer
Colon Cancer
Pancreatic Cancer
Head and Neck Cancer
Kidney Cancer
Sarcoma
Hepatocellular Cancer
Interventions: Drug: Pazopanib
Drug: Ixabepilone

  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
No text entered.

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: Dose Level 1 Pazopanib 400mg - Ixabepilone 32mg/m2
Arm 1: Dose Level 2 Pazopanib 400mg - Ixabepilone 40mg/m2
Arm 1: Dose Level 3 Pazopanib 600mg - Ixabepilone 32 mg/m2
Arm 1: Dose Level 4 Pazopanib 800mg - Ixabepilone 32 mg//m2
Arm 2 Pazopanib 600mg - Ixabepilone 32 mg/m2. This is an additional cohort of head and neck cancer patients treated at the optimal tolerated regimen for the purpose of performing pharmacokinetics, confirm safety information and obtainadditional preliminary efficacy data in this patient population.

Participant Flow:   Overall Study
    Arm 1: Dose Level 1   Arm 1: Dose Level 2   Arm 1: Dose Level 3   Arm 1: Dose Level 4   Arm 2
STARTED   9   6   9   4   3 
COMPLETED   9   6   9   4   3 
NOT COMPLETED   0   0   0   0   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: Dose Level 1 Pazopanib 400mg - Ixabepilone 32mg/m2
Arm 1: Dose Level 2 Pazopanib 400mg - Ixabepilone 40mg/m2
Arm 1: Dose Level 3 Pazopanib 600mg - Ixabepilone 32 mg/m2
Arm 1: Dose Level 4 Pazopanib 800mg - Ixabepilone 32 mg//m2
Arm 2 Pazopanib 600mg - Ixabepilone 32 mg/m2. This is an additional cohort of head and neck cancer patients treated at the optimal tolerated regimen for the purpose of performing pharmacokinetics, confirm safety information and obtainadditional preliminary efficacy data in this patient population.
Total Total of all reporting groups

Baseline Measures
   Arm 1: Dose Level 1   Arm 1: Dose Level 2   Arm 1: Dose Level 3   Arm 1: Dose Level 4   Arm 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   6   9   4   3   31 
Age 
[Units: Participants]
Count of Participants
           
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      6  66.7%      5  83.3%      7  77.8%      3  75.0%      3 100.0%      24  77.4% 
>=65 years      3  33.3%      1  16.7%      2  22.2%      1  25.0%      0   0.0%      7  22.6% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      6  66.7%      1  16.7%      3  33.3%      1  25.0%      0   0.0%      11  35.5% 
Male      3  33.3%      5  83.3%      6  66.7%      3  75.0%      3 100.0%      20  64.5% 


  Outcome Measures
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1.  Primary:   The Optimal Tolerated Regimen of Pazopanib and Ixabepilone When Used in Combination   [ Time Frame: At first cycle (Week 3) ]

2.  Secondary:   To Obtain Preliminary Toxicity and Tolerability of This Drug Regimen.   [ Time Frame: Up to 30 days post treatment ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Arkadiusz Dudek
Organization: Masonic Cancer Center, University of Minnesota
phone: 651-254-3321
e-mail: Arkadiusz.Z.Dudek@HealthPartners.com



Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT01012362     History of Changes
Other Study ID Numbers: 2009LS001
0906M68402 ( Other Identifier: Institutional Review Board, University of Minnesota )
NCI-2009-01444 ( Registry Identifier: National Cancer Institute website )
Study First Received: November 12, 2009
Results First Received: April 11, 2017
Last Updated: April 11, 2017