Pazopanib as Front-Line Therapy in Patients With Non-Resectable or Metastatic Soft Tissue Sarcomas Who Are Not Candidates for Chemotherapy
|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.|
|ClinicalTrials.gov Identifier: NCT02300545|
Recruitment Status : Active, not recruiting
First Posted : November 25, 2014
Last Update Posted : July 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma, Soft Tissue Soft Tissue Sarcoma||Drug: Pazopanib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Pazopanib as Front-Line Therapy in Patients With Non-Resectable or Metastatic Soft Tissue Sarcomas Who Are Not Candidates for Chemotherapy|
|Actual Study Start Date :||April 8, 2015|
|Actual Primary Completion Date :||May 31, 2019|
|Estimated Study Completion Date :||November 30, 2020|
Pazopanib will be started at a dose of 200 mg BID for four days, then escalated to a dose of 400 mg BID for four days, then escalated once more to a dose of 800 mg QD for the duration of participation (or until dose reduction, if necessary). Pazopanib should be taken orally without food at least one hour before or two hours after a meal. One cycle of pazopanib is 28 days.
- Clinical benefit rate [ Time Frame: 16 weeks ]
Clinical benefit rate = complete response (CR) + partial response (PR) + stable disease (SD)
- CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
- PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
- SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
- Progression-free survival (PFS) [ Time Frame: until disease progression (estimated median PFS 4.6 months) ]
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
- Overall survival (OS) [ Time Frame: until death (estimated median OS 18 months) ]
- Quality of life [ Time Frame: until removal from study treatment (estimated median PFS 4.6 months) ]
Quality of life will be measured using the FACT-G7 validated survey at baseline, C1D15, and on Day 1 of each cycle
7 questions where the participant can indicate 0 (not at all) up to 4 (very much).
- Clinical outcome associated with serum sVEGFR2 levels (erum levels of sVEGFR2 at each time point will plotted and Pearson or Spearman's correlation coefficient) [ Time Frame: Completion of 4 cycles (approximately 4 months) ]The serum levels of sVEGFR2 at each time point will plotted and Pearson or Spearman's correlation coefficient will be calculated to explore their relationship.
- Clinical outcome associated with serum PICG levels (serum levels of PIGF at each time point will plotted and Pearson or Spearman's correlation coefficient) [ Time Frame: Completion of 4 cycles (approximately 4 months) ]The serum levels of PIGF at each time point will plotted and Pearson or Spearman's correlation coefficient will be calculated to explore their relationship.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300545
|United States, Arizona|
|Mayo Clinic - Phoenix|
|Phoenix, Arizona, United States, 85054|
|United States, Florida|
|Mayo Clinic - Jacksonville|
|Jacksonville, Florida, United States, 32224|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States, 52242|
|United States, Minnesota|
|Mayo Clinic - Rochester|
|Rochester, Minnesota, United States, 55905|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, Wisconsin|
|University of Wisconsin Clinical Science Center|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Brian A Van Tine, M.D., Ph.D.||Washington University School of Medicine|