NCT02367651

Study of Pazopanib Versus Placebo as Maintenance Therapy for Advanced Soft Tissue Sarcoma

A Randomized, Double-blind, Placebo-controlled Phase II Study of Pazopanib Versus Placebo as Maintenance Therapy for Patients Who Have Not Progressed After First-line Chemotherapy for Advanced Soft Tissue Sarcoma (STS)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sarcoma, Soft Tissue

Interventions

Type	Name	Description
DRUG	Pazopanib 800 mg	Aqueous film-coated, oval-shaped, white tablets containing either 200 mg or 400 mg pazopanib
DRUG	Placebo	Tablets matching the 200 mg and 400 mg pazopanib tablets

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2015-02-20
• Last updated: 2016-10-12