Study of Pazopanib Versus Placebo as Maintenance Therapy for Advanced Soft Tissue Sarcoma
Status:
Withdrawn
Trial end date:
2018-05-01
Target enrollment:
Participant gender:
Summary
Pazopanib monotherapy is approved by the Food and Drug Administration (FDA), European
Medicines Agency, and other regulatory authorities worldwide for the treatment of patients
with advanced renal cell carcinoma and patients with advanced soft tissue sarcoma (STS) who
received prior chemotherapy. Based on the improved progression-free survival and sustained
responses observed in a pivotal Phase 3, randomized, placebo-controlled study, it is
hypothesized that pazopanib may have a role in a maintenance setting for STS in maintaining
the initial response to chemotherapy and delaying the need for further treatment at relapse
and its associated toxicity and impact on health-related quality-of-life. This Phase 2,
randomized, double-blind, placebo-controlled study will evaluate maintenance therapy with
pazopanib versus placebo in subjects with advanced or metastatic STS who have not progressed
after 4 to 6 cycles of first-line anthracycline-based chemotherapy. Approximately 188
eligible subjects will be randomized in a 1:1 ratio to treatment with pazopanib 800
milligrams (mg) daily or placebo. Study completion will be the point at which 70% of
randomized subjects have died. Once a subject has objective evidence of disease progression,
the subject will be managed as per standard practice by their physician. Subjects will
continue to be followed for second progression, health related quality of life, survival
until study completion, withdrawal of consent, or early termination of the study.