Study of Pazopanib and Doxil in Patients With Advanced Relapsed Platinum-Sensitive or Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Adenocarcinoma

This study has been terminated.
(Based on analyses in Phase I, the study did not advance to Phase II.)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT01035658
First received: December 17, 2009
Last updated: May 18, 2015
Last verified: May 2015
Results First Received: December 16, 2014  
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: Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Carcinoma
Interventions: Drug: Pazopanib
Drug: Doxil

  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
Dose Level 1

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Dose Level -1

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Dose Level 1 Sequential

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Dose Level 2 Sequential

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle


Participant Flow:   Overall Study
    Dose Level 1     Dose Level -1     Dose Level 1 Sequential     Dose Level 2 Sequential  
STARTED     5     8     3     6  
COMPLETED     5     8     3     6  
NOT COMPLETED     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
Dose Level 1

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Dose Level -1

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Dose Level 1 Sequential

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Dose Level 2 Sequential

Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.

Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.

Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Total Total of all reporting groups

Baseline Measures
    Dose Level 1     Dose Level -1     Dose Level 1 Sequential     Dose Level 2 Sequential     Total  
Number of Participants  
[units: participants]
  5     8     3     6     22  
Age  
[units: years]
Median (Full Range)
  62   (51 to 69)     74   (31 to 90)     64   (51 to 64)     57   (49 to 79)     64   (31 to 90)  
Gender  
[units: participants]
         
Female     5     8     3     6     22  
Male     0     0     0     0     0  
Region of Enrollment  
[units: participants]
         
United States     5     8     3     6     22  



  Outcome Measures
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1.  Primary:   Phase I: Number of Subjects With Dose-limiting Toxicities (DLTs) as a Measure of Safety and Tolerability   [ Time Frame: 18 months ]

2.  Primary:   Phase II: Progression Free Survival   [ Time Frame: 18 months ]

3.  Primary:   Phase I - Dose Limiting Toxicites   [ Time Frame: 18 months ]

4.  Secondary:   To Determine the Overall Survival of Patients With Relapsed/Refractory Ovarian Cancer Following Treatment With Pazopanib and Liposomal Doxorubicin.   [ Time Frame: 18 months ]

5.  Secondary:   To Evaluate the Toxicity of the Combination of Pazopanib and Liposomal Doxorubicin   [ Time Frame: 18 months ]

6.  Secondary:   To Determine the Efficacy of Pazopanib/Liposomal Doxorubicin (Response Rate, Progression-free Survival, Overall Survival) Separately in the Subsets of Patients With Platinum-sensitive and Platinum-refractory Ovarian Carcinoma   [ Time Frame: 18 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
Per protocol, study did not proceed to phase II based on analyses from phase I. Therefore, Phase II outcomes (all outcomes other than determination of the MTD) were not evaluated and will not be posted.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: John D. Hainsworth, MD
Organization: Sarah Cannon Research Institute
phone: 1-877-691-7274
e-mail: asksarah@scresearch.net


No publications provided


Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT01035658     History of Changes
Other Study ID Numbers: SCRI GYN 26
Study First Received: December 17, 2009
Results First Received: December 16, 2014
Last Updated: May 18, 2015
Health Authority: United States: Food and Drug Administration