Neoplasms

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Gastrointestinal Stromal Tumors

Sarcoma

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Sunitinib

Imatinib Mesylate

Two (2) tablets of 400 mg given once daily continuously

Pazopanib

Mikael Eriksson, MD PhD

Patients with metastatic or locally advanced gastrointestinal stromal tumors (GIST) who develop resistance against the two hitherto approved drugs for this disease, the tyrosin kinase inhibitors (TKIs) imatinib and sunitinib, have a poor prognosis. Sometimes a further response may be achieved by other drugs, mainly other TKIs, which have been explored in different studies but not yet have been approved for clinical use. Pazopanib is a TKI inhibiting the tyrosin kinases KIT, PDGFRA, and VEGF 1-3, all of which have important roles in the pathogenesis of GIST. Theoretically, it may function in GIST, and it deserves investigational trials. The drug is approved for metastatic renal cancer and is relatively well tolerated. In this trial (SSG XXI), the disease control rate (DCR) = (CR+PR+SD) after 12 weeks of treatment will be assessed as the primary endpoint, and at the same time trough levels will be measured. Secondary endpoints include ORR, PFS, toxicity, and disease control rate in relation to trough level week 12 and in relation to the primary mutation of the tumor (if known). The goal is to include 72 patients in the trial, which is open and single arm.

Pazopanib in Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib

Pazopanib in Advanced GISTs Refractory to Imatinib and Sunitinib - A Non-comparative Phase II Multicenter Study by the Scandinavian Sarcoma Group

The ratio of patients with CR (complete remission) + PR (partial remission) + SD (stable disease) at week 12 after start of treatment

Progression free survival (KM analysis) for all patients administered the study drug

Disease control rate as described above in relation to the type of mutation of the primary tumor if this is available (not mandatory)

Disease control rate as defined above in relation to the trough level (plasma concentration) of the study drug at week 12

Recording of adverse events including SAE/SAR for all patients administered the study drug

ORR = CR+PR at the time of best response during the study period

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pazopanib in Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib	NCT01524848	Gastrointestina...	Pazopanib	18 Years -	Scandinavian Sarcoma Group
Pazopanib in Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib	NCT01524848	Gastrointestina...	Pazopanib	18 Years -	Scandinavian Sarcoma Group

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