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NCT02300545

Pazopanib as Front-Line Therapy in Patients With Non-Resectable or Metastatic Soft Tissue Sarcomas Who Are Not Candidates for Chemotherapy

Completed Phase 2 Results posted Last updated 5 August 2020
What this trial tests

Phase 2 trial testing Pazopanib in Sarcoma, Soft Tissue in 56 participants. Completed in 11 July 2020.

Timeline
8 April 2015
Primary endpoint
31 May 2019
11 July 2020

Quick facts

Lead sponsorWashington University School of Medicine
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment56
Start date8 April 2015
Primary completion31 May 2019
Estimated completion11 July 2020
Sites7 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Sarcoma, Soft Tissue or Soft Tissue Sarcoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Clinical Benefit Rate Primary · 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.

GroupValue95% CI
Pazopanib22
Progression-free Survival (PFS) Secondary · Until disease progression (median follow-up of 10.83 months with full range 0.787-42.26 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).

GroupValue95% CI
Pazopanib3.672.62 – 7.25
Overall Survival (OS) Secondary · Until death (median follow-up of 10.83 months with full range 0.787-42.26 months)
GroupValue95% CI
Pazopanib14.168.46 – NA
Median Overall Change in Quality of Life Secondary · Change from baseline to end of treatment (median length of treatment 70 days (5-515 days)))

* Quality of life will be measured using the Functional Assessment of Cancer Therapy-General (FACT-G7) validated survey * 7 statements where the participant can indicate 0 (not at all) up to 4 (very much). The statements include 1) I have lack of energy; 2) I have pain; 3) I have nausea; 4) I worry that my condition will get worse; 5) I am sleeping well; 6) I am able to enjoy life; 7) I am content with the quality of my life right now. * The first 4 statements will negatively affect the total score and the last 3 statements will positively affect the total score * Each item is scored and then

GroupValue95% CI
Pazopanib20.7356979 – 4.5834510

Adverse events — posted to ClinicalTrials.gov

Time frame: -Reportable adverse events were tracked for 30 days following the last day of study treatment. Median treatment length was 70 days (5 days-515 days). As of first reporting of results, one participant is still receiving treatment.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pazopanib
Serious: 27/56 (48%)
Deaths: 24/56

Serious adverse events (34 terms)

ReactionSystemPazopanib
Alanine aminotransferase increasedMetabolism and nutrition disorders
PneumothoraxRespiratory, thoracic and mediastinal disorders
Thromboembolic eventVascular disorders
Heart failureCardiac disorders
ColitisInfections and infestations
Lung infectionInfections and infestations
DehydrationMetabolism and nutrition disorders
Generalized muscle weaknessMusculoskeletal and connective tissue disorders
Pleural effusionRespiratory, thoracic and mediastinal disorders
Acute coronary syndromeCardiac disorders
Atrial flutterCardiac disorders
Sinus tachycardiaCardiac disorders
Anal hemorrhageGastrointestinal disorders
Bowel infarction related to diseaseGastrointestinal disorders
Colonic fistulaGastrointestinal disorders
DiarrheaGastrointestinal disorders
GI bleedGastrointestinal disorders
Jejunal perforationGastrointestinal disorders
NauseaGastrointestinal disorders
PancreatitisGastrointestinal disorders
Upper gastrointestinal hemorrhageGastrointestinal disorders
FatigueGeneral disorders
Bronchial infectionInfections and infestations
FallInjury, poisoning and procedural complications
FractureInjury, poisoning and procedural complications
Other adverse events (104 terms — click to expand)

ReactionSystemPazopanib
FatigueGeneral disorders
DiarrheaGastrointestinal disorders
NauseaGastrointestinal disorders
HypertensionVascular disorders
Aspartate aminotransferase increasedInvestigations
VomitingGastrointestinal disorders
AnemiaBlood and lymphatic system disorders
AnorexiaMetabolism and nutrition disorders
Platelet count decreasedInvestigations
White blood cell decreasedInvestigations
Alanine aminotransferase increasedInvestigations
DysgeusiaNervous system disorders
Blood bilirubin increasedInvestigations
Abdominal painGastrointestinal disorders
ConstipationGastrointestinal disorders
Gastroesophageal reflux diseaseGastrointestinal disorders
Weight lossInvestigations
HeadacheNervous system disorders
Lymphocyte count decreasedInvestigations
Generalized muscle weaknessMusculoskeletal and connective tissue disorders
MyalgiaMusculoskeletal and connective tissue disorders
DizzinessNervous system disorders
Alkaline phosphatase increasedInvestigations
Neutrophil count decreasedInvestigations
HyponatremiaMetabolism and nutrition disorders
AlopeciaSkin and subcutaneous tissue disorders
HypothyroidismEndocrine disorders
FlatulenceGastrointestinal disorders
HypoalbuminemiaMetabolism and nutrition disorders
ArthralgiaMusculoskeletal and connective tissue disorders
Blurred visionEye disorders
Mucositis oralGastrointestinal disorders
Oral painGastrointestinal disorders
DehydrationMetabolism and nutrition disorders
Muscle weakness lower limbMusculoskeletal and connective tissue disorders
Memory impairmentNervous system disorders
DyspneaRespiratory, thoracic and mediastinal disorders
EpistaxisRespiratory, thoracic and mediastinal disorders
HoarsenessRespiratory, thoracic and mediastinal disorders
Dry mouthGastrointestinal disorders

Most-reported serious reactions: Alanine aminotransferase increased, Pneumothorax, Thromboembolic event, Heart failure, Colitis, Lung infection, Dehydration, Generalized muscle weakness.

Data from ClinicalTrials.gov NCT02300545 adverse events section.

Sponsor's own description

Pazopanib is FDA approved as a second line and beyond treatment for metastatic soft tissue sarcoma. There is a population of elderly and debilitated soft tissue sarcoma patients that are not fit for standard first line chemotherapy that is doxorubicin based. As pazopanib is well tolerated with minimal side effects, the investigators propose a phase II study to evaluate pazopanib as a first-line agent in patients with non-resectable or metastatic disease who are not candidates for cytotoxic chemotherapy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Genetic Alterations and Deregulation of Hippo Pathway as a Pathogenetic Mechanism in Bone and Soft Tissue Sarcoma.
    Salguero-Aranda C, Olmedo-Pelayo J, de Álava E, Amaral AT, et al · · 2022 · cited 8× · PMID 36551696 · DOI 10.3390/cancers14246211

Verify or expand the search:

Other trials of Pazopanib

Trials testing the same drug.

Other recruiting trials for Sarcoma, Soft Tissue

Currently open trials in the same condition.

Other Washington University School of Medicine trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02300545.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing