NCT01753713

Dovitinib in Treating Patients With Recurrent or Progressive Glioblastoma

Phase II Study of TKI258 (Dovitinib) in Patients With Recurrent or Progressive Glioblastoma Who Have Progressed With or Without Anti-Angiogenic Therapy (Including Anti-VEGF Therapy)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Manmeet Ahluwalia, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well dovitinib works in treating patients with recurrent or progressive glioblastoma. Dovitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Detailed description

PRIMARY OBJECTIVES: Anti-angiogenic Therapy Naive Patients: To determine 6 month progression-free survival (PFS6) in anti-angiogenic therapy (including anti-vascular endothelial growth factor (VEGF) therapy or bevacizumab) naive patients with recurrent glioblastoma (GBM) in patients treated with dovitinib Anti-angiogenic Therapy Patients: To estimate time to progression in patients with recurrent or progressive Glioblastoma who have progressed on anti-angiogenic therapy (including anti-VEGF therapy). SECONDARY OBJECTIVES: 1. To evaluate the side effect profile of dovitinib in both patient populations. 2. To evaluate the efficacy of dovitinib as measured by objective response rate (ORR) in both patient populations. 3. To estimate time to percentage of patients free from progression at 6 months (PFS-6)in patients with recurrent or progressive Glioblastoma who have progressed on antiangiogenic therapy (including anti-VEGF therapy). (Anti-angiogenic Therapy Patients) 4. To estimate time to progression in anti-angiogenic therapy (including anti-VEGF therapy or bevacizumab) naiVe patients with recurrent glioblastoma (GBM) in patients treated with dovitinib. (Anti-angiogenic Therapy Naive Patients) 5. To evaluate the overall survival (OS) in both patient populations. EXPLORATORY OBJECTIVES: To explore association between clinical outcome and potential biomarkers that may include microparticles, PlGF, PDGF-AA, PDGF-AB, PDGF-BB, SDF-1a, thrombospondin-1, Ang1, and Il-6, IL-8 and FGF. OUTLINE: Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.

Conditions

• Adult Giant Cell Glioblastoma
• Adult Glioblastoma
• Adult Gliosarcoma
• Recurrent Adult Brain Tumor

Interventions

Type	Name	Description
DRUG	dovitinib	Given PO
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2012-12-20
• Primary completion: 2015-01-28
• Completion: 2017-09-20
• First posted: 2012-12-20
• Last updated: 2017-12-12
• Results posted: 2017-08-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study