Pazopanib as treatment for advanced gastrointestinal stromal tumors not any longer responding to standard treatment with the drugs imatinib or sunitinib - A study without comparator as placebo or another drug, performed at many sites and sponsored by the Scandinavian Sarcoma Group

Pazopanib in advanced gastrointestinal stromal tumors refractory to imatinib and sunitinib . A non-comparative phase II multicenter study by the Scandinavian Sarcoma Group - PAGIST

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004404-37-SE

Enrollment

Registered

2011-09-19

Start date

2011-11-01

Completion date

Unknown

Last updated

2022-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gatrointestinal stromal tumor (GIST)

Interventions

Trade Name: VOTRIENT Product Name: pazopanib Product Code: GW786034 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: PAZOPANIB CAS Number: 444731-52-6 Current Sponsor code: GW786034 Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a) metastatic and/or locally advanced GIST b) measurable disease as defined by RECIST c) progressive disease after both imatinib and sunitinib treatment, and also after nilotinib if this drug ha been given d) no other tyrosin kinase inhibitors given than imatinib, sunitinib, and nilotinib e) age at least 18 years f) WHO performance status 0-2 g) resolution of toxic side effects from earlier treatment h) sufficient organ functions as defined in the protocol i) acceptence to use adequate contraception throughout the study period for women with childbearing potential j) written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 42

Exclusion criteria

Exclusion criteria: a) prior malignancy if claiming active treatment or otherwise is judged to be of significance for the study treatment b) clinically significant gastrointestinal bleeding c) uncontrolled infection of significance d) major surgery or trauma within 28 days priot to the start of study treatment e) active bleeding or bleeding diathesis f) endobronchial lesions or lesions infiltrating major pulmonary vessels g) medical, psychiatric or other condition that could interfere with safety or compliance h) pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Main Objective: Calculate the disease control rate (DCR)=complete remission (CR)+partial remission (PR) + stable disease (SD) at 12 weeks;Secondary Objective: 1. Calculate overall response rate (ORR=CR+PR) at the time of best response since start of pazopanib 2. Calculate progression free survival (PFS) for patients administered pazopanib 3. Calculate DCR in relation to mutational status of primary tumor sample 4. Calculate DCR in relation to plasma concentration at week 12 5. Assess the toxicity in patients treated with pazopanib;Primary end point(s): Disease control rate (DCR=CR+PR+SD) at 12 weeks from start of pazopanib treatment according to RECIST version 1.1;Timepoint(s) of evaluation of this end point: 12 weeks from start of treatment	—

Measure

Time frame

Main Objective: Calculate the disease control rate (DCR)=complete remission (CR)+partial remission (PR) + stable disease (SD) at 12 weeks;Secondary Objective: 1. Calculate overall response rate (ORR=CR+PR) at the time of best response since start of pazopanib 2. Calculate progression free survival (PFS) for patients administered pazopanib 3. Calculate DCR in relation to mutational status of primary tumor sample 4. Calculate DCR in relation to plasma concentration at week 12 5. Assess the toxicity in patients treated with pazopanib;Primary end point(s): Disease control rate (DCR=CR+PR+SD) at 12 weeks from start of pazopanib treatment according to RECIST version 1.1;Timepoint(s) of evaluation of this end point: 12 weeks from start of treatment

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Secondary

Measure	Time frame
Secondary end point(s): 1. Overall response rate (ORR) defined as the fraction of patients ever achieving CR or PR during protocol treatment 2. Progression free survival (PFS) defined as the time from start of pazopanib to progressive disease according to RECIST version 1.1 3. DCR in relation to mutational status of primary tumor sample 4. DCR in relation to plasma concentration of pazopanib at week 12 of treatment 5. Toxicity defined as adverse events and abnormal laboratory test results;Timepoint(s) of evaluation of this end point: For 1, 2, and 5 above - continously during protocol treatment; for 5 also including 30 days after end of treatment For 3 and 4 - at week 12 of treatment	—

Measure

Time frame

Secondary end point(s): 1. Overall response rate (ORR) defined as the fraction of patients ever achieving CR or PR during protocol treatment 2. Progression free survival (PFS) defined as the time from start of pazopanib to progressive disease according to RECIST version 1.1 3. DCR in relation to mutational status of primary tumor sample 4. DCR in relation to plasma concentration of pazopanib at week 12 of treatment 5. Toxicity defined as adverse events and abnormal laboratory test results;Timepoint(s) of evaluation of this end point: For 1, 2, and 5 above - continously during protocol treatment; for 5 also including 30 days after end of treatment For 3 and 4 - at week 12 of treatment

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Countries

Denmark, Finland, Germany, Iceland, Sweden

Contacts

Public ContactSSG secretariat

Scandinavian Sarcoma Group

ssg@med.lu.se4646275 21 82

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026