At a glance
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PAZOPANIB Efficacy and Tolerance in Desmoids Tumors : Phase 2 Clinical Trial
In Brief
A Phase 2 clinical trial evaluating PAZOPANIB treatment and Active Comparator: Vinblastine and Methotrexate for Progressive Desmoids Tumors. Completed, enrolled 72 participants across 1 site.
Detailed Summary
Desmoids tumors are benign soft tissues tumors characterized by aggressiveness and potential local recurrence. There is a female predominance with a sex ratio of 2/1 and median age at diagnosis is about 30 years. Only a complete surgical excision is recommended in desmoids tumors. Some forms of desmoid tumors are recurrent and/or symptomatic and are not accessible to a conservative surgical treatment. In these clinical situations, only a medical treatment may achieve tumor control and quality of life maintenance. Place of systemic treatments in the management of desmoids tumors is poorly evaluated. Regarding chemotherapy, methotrexate and vinblastine protocol is actually the best evaluated combination, which allowed observing objective response rate between 40 and 75%. Toxicity was mainly marked by the risk of haematological toxicity. Pazopanib is an inhibitor of multi-target tyrosine kinase, in oral form, with selective type receptors -1, -2 and -3 of VEGF receptors on the PDGFA and B, and c-Kit. It is currently under clinical development in humans in the treatment of several tumor types.
Study Details
Timeline
Interventions
Pazopanib * 800 mg per day * oral administration * at least 1 hour before or 2 hours after a meal, * until disease progression or for 12 months maximum
Active Comparator: Vinblastine and Methotrexate vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months.