PAZOPANIB Efficacy and Tolerance in Desmoids Tumors (NCT01876082) | Clinical Trial Compass
CompletedPhase 2
PAZOPANIB Efficacy and Tolerance in Desmoids Tumors
France72 participantsStarted 2012-09-18
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written consent;
✓. Age ≥ 18 years;
✓. ECOG ≤ 1;
✓. Histologically confirmed desmoid tumor;
✓. Disease progression before the patient's inclusion : completion of two similar imaging obtained within 6 months apart (a tolerance of 6 weeks is accepted)
✓. Measurable target lesion (RECIST criteria) ;
✓. Left ventricular ejection fraction (MUGA or ECHO) within the normal;
✓. Normal hematological, renal and liver functions :
Exclusion criteria
✕. Personal history of malignancy except:
✕. Cervical intraepithelial neoplasia;
✕. Skin basal cell carcinoma;
What they're measuring
1
Percentage of Patients Remaining Alive and Progression-free at 6 Months as Per RECIST 1.1 After the Day of Randomisation (6-month Non-progression Rate).