NCT02267967

Phase Ib/II Study of Sulfatinib in Treating Advanced Neuroendocrine Tumors

A Multi-Center, Open-Label, Phase Ib/II Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Sufatinib in Treating Advanced Neuroendocrine Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

a multicenter, open-label phase Ib study to determine the safety, tolerability and preliminary efficacy of Sulfatinib 300 mg once a day in treating advanced neuroendocrine tumors

Detailed description

The study population is patients with low- or intermediate-grade (G1 or G2) advanced NET who have failed in standard treatment or are unable to receive standard treatment.Sulfatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle. Investigators will evaluate the clinical tumor response to Sulfatinib, and if investigators determine that the patient can benefit from the continuation of treatment, the patient will continue the Sulfatinib treatment. The duration of study will be 2 years. At the time of study completion, if investigators believe patients can continue to benefit from the investigational product, patients may be provided with Sulfatinib with the agreement of the sponsor.

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	Sulfatinib	Sulfatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle.

Timeline

• Start date: 2014-10-31
• Primary completion: 2017-08-23
• Completion: 2017-08-23
• First posted: 2014-10-20
• Last updated: 2018-11-13

Locations

7 sites across 1 country: China