Clinical Trials Logo
  1. Home
  2. Sarcoma, Soft Tissue
  3. NCT02367651

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

Sarcoma, Soft Tissue Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02367651
Study type Interventional
Source GlaxoSmithKline
Contact
Status Withdrawn
Phase Phase 2
Start date June 2015
Completion date May 2018
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03985722 - Olaratumab Plus Trabectedin in Advanced Soft-tissue Sarcoma Patients Soft-tissue Sarcoma Patients Phase 1
Withdrawn NCT02464332 - Safety Study of BLZ-100 in Adult Subjects With Sarcoma Undergoing Surgery Phase 1
Completed NCT00289809 - TLC D-99 and Ifosfamide in Metastatic Soft Tissue Sarcoma Patients Phase 1/Phase 2
Completed NCT00243685 - Chemotherapy Drug Sensitivity Microculture (MiCK) Assay for Apoptosis Phase 2/Phase 3
Active, not recruiting NCT01185964 - A Study of IMC-3G3 in Soft Tissue Sarcoma Phase 1/Phase 2
Completed NCT00753688 - Pazopanib Versus Placebo in Patients With Soft Tissue Sarcoma Whose Disease Has Progressed During or Following Prior Therapy Phase 3
Completed NCT00093080 - Study of AP23573/MK-8669 (Ridaforolimus), A Mammalian Target of Rapamycin (mTOR) Inhibitor, in Participants With Advanced Sarcoma (MK-8669-018 AM1)(COMPLETED) Phase 2
Completed NCT00187174 - Everolimus for Treating Pediatric Patients With Recurrent or Refractory Tumors Phase 1
Completed NCT03798795 - Radiomics for Tumor Grading of Soft Tissue Sarcomas.
Terminated NCT02929394 - Trabectedin Maintenance Post 1st-line in STS Phase 3
Recruiting NCT02275286 - Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients Phase 1/Phase 2
Completed NCT00406601 - BAY-43-9006 in Advanced, Metastatic Soft Tissue Sarcomas Phase 2
Completed NCT00297258 - Pazopanib In Patients With Relapsed Or Refractory Soft Tissue Sarcoma Phase 2
Active, not recruiting NCT06114173 - Efficacy and Safety Study of Cardunilizumab in Soft Tissue Sarcoma Early Phase 1
Completed NCT00061659 - Study Evaluating the Safety and Efficacy of ABT-510 in Subjects With Locally Advanced or Metastatic Soft Tissue Sarcoma Phase 2
Recruiting NCT03815474 - Anlotinib Hydrochloride Combined With Epirubicin and Ifosfamide for Soft Tissue Sarcoma Patients Phase 2
Recruiting NCT02812654 - Ifosfamide, Doxorubicin and Hypofractionated Radiotherapy in Neoadjuvant Sarcoma Treatment Phase 2
Completed NCT00204620 - Bendamustin Hydrochloride in Patients With Soft Tissue Sarcoma (STS) Phase 2
Completed NCT03058406 - A Study on Safety and Efficacy in Patients With Soft Tissue Sarcomas
Active, not recruiting NCT02415816 - Diffusion Weighted Magnetic Resonance in Imaging Younger Patients With Newly Diagnosed Bone or Soft Tissue Sarcomas N/A