Randomized Phase II Trial of Sunitinib or Cediranib in Alveolar Soft Part Sarcoma.

ABSTRACT:

Purpose

Alveolar soft part sarcoma (ASPS) is a rare, highly vascular tumor with few treatment options. We designed a phase II randomized trial to determine the activity and tolerability of single-agent cediranib or sunitinib in patients with advanced metastatic ASPS.

Patients and methods

Patients 16 years of age and older were randomized to receive cediranib (30 mg) or sunitinib (37.5 mg) in 28-day cycles. Patients could cross over to the other treatment arm at disease progression. The primary endpoint was to measure the objective response rate (ORR) for each agent. Median progression-free survival (mPFS) for the two arms was also determined.

Results

Twenty-nine of 34 enrolled patients were evaluable for response. One patient on each of the initial two treatment arms

SUBMITTER: Nguyen J 

PROVIDER: S-EPMC10068440 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature