PALETTE — Pazopanib Versus Placebo in Metastatic Non-Adipocytic Soft-Tissue Sarcoma After Chemotherapy

Phase 3 · 2012 · Soft Tissue Sarcoma

Design

Randomized 2:1, double-blind, to pazopanib 800 mg once daily vs placebo, with no crossover.

Population

Angiogenesis-inhibitor-naive metastatic non-adipocytic soft-tissue sarcoma progressing after standard chemotherapy (excludes adipocytic sarcoma and GIST).

Primary Endpoint

progression-free survival (PFS)

Key Result

Median PFS 4.6 vs 1.6 mo (HR 0.31, P<0.0001); OS 12.5 vs 10.7 mo (HR 0.86, P=0.25) — OS difference not significant.

Guideline Impact

NCCN-endorsed pazopanib for pretreated non-adipocytic soft-tissue sarcoma