NCT02455596

Recombinant Anti-tumor and Anti-virus Protein for Injection to Treat Advanced Neuroendocrine Tumors

Phase II Study of Recombinant Anti-tumor and Anti-virus Protein for Injection to Treat Advanced Neuroendocrine Tumors

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor and anti-virus protein for injection in treating patients with advanced neuroendocrine tumors who have failed standard treatment or are unable to receive standard treatment.

Detailed description

This is a Phase Ⅱ exploratory clinical study. The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor and anti-virus protein for injection in treating patients with advanced neuroendocrine tumors who have failed standard treatment or are unable to receive standard treatment. Recombinant anti-tumor and anti-virus protein for injection, 10μg,im,3 times for the first week, followed by 20μg for two weeks, and followed a maintenance dose of 30μg, the frequency of administration is three times per week. Treatment continued until the patient died or had unacceptable toxicity or had disease progression or required to discontinue the treatment. At the time of disease progression, if investigators believe patients can continue to benefit from the investigational product, patients may be provided with recombinant anti-tumor and anti-virus protein for injection,but only survival follow-up datas will be recorded.

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	Recombinant anti-tumor and anti-virus protein for injection (Novaferon)	Recombinant anti-tumor and anti-virus protein for injection, 10μg, im, 3 times for first week,followed by 20μg for two weeks, and followed a maintenance dose of 30μg, the frequency of administration is three times per week.

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-10-01
• Completion: 2016-12-01
• First posted: 2015-05-28
• Last updated: 2016-01-05

Locations

1 site across 1 country: China