NCT02455596

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 5, 2016

Status Verified

October 1, 2015

Enrollment Period

1.4 years

First QC Date

May 21, 2015

Last Update Submit

January 4, 2016

Conditions

Neuroendocrine Tumors

Keywords

NovaferonRecombinant anti-tumor and anti-virus protein for injectionCarcinoid TumorPancreatic Neuroendocrine Tumor

Outcome Measures

Primary Outcomes (2)

  • Progression-free survival (PFS)

    PFS is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.

    1 year

  • Disease control rate(DCR)

    DCR is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments.

    1 year

Secondary Outcomes (3)

  • Overall response rate(ORR)

    1 year

  • Overall survival (OS)

    3 years

  • Adverse Events(AEs)

    1 year

Study Arms (1)

Experimental

EXPERIMENTAL

Recombinant anti-tumor and anti-virus protein for injection(Novaferon), three times per week.

Drug: Recombinant anti-tumor and anti-virus protein for injection (Novaferon)

Interventions

Recombinant anti-tumor and anti-virus protein for injection (Novaferon)DRUG

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.

Also known as: Novaferon
Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have been fully aware of the study and voluntarily signed the informed consent.
  • At least 18 years old.
  • Have a confirmed histological or cytological diagnosis of low- or intermediate-grade advanced NETs (unresectable or metastatic), the pathology must meet one of the following criteria: (a) primary site of lung or thymus (carcinoid) with mitotic count of ≤ 10/10 High Power Field \[HPF\]) (b) other primary site (including primary unknown) with mitotic count of ≤ 20/10 High Power Field \[HPF\] and Ki67 index of ≤ 20%，or with Ki67 index of \> 20% and well-differentiated.
  • Patients who have failed standard treatment or are unable to receive standard treatment, and have disease progression within the past 12 months;
  • At least one measurable lesion according to the RECIST 1.1 criteria that has not been previously locally treated.
  • ECOG performance status 0, 1 or 2.
  • Minimum of 4 weeks since any local radiotherapy or surgery for the control of symptoms or severe complications(local radiotherapy for the control of bone metastases is not the limit)，and adequately recovered from toxicities of any prior therapy).
  • Life expectancy of at least 3 months.

You may not qualify if:

  • Prior treatment with Recombinant Anti-tumor and Anti-virus Protein for Injection.
  • Prior treatment with Interferon.
  • Pregnancy or breast-feeding women or women who may be pregnant were positive drug test before administration.
  • Patient of child-bearing potential(male or less than 1 year postmenopausal women) were reluctant to take contraceptive measures.
  • Patient who were allergic to Interferon-α or who had interferon-α antibody.
  • Have brain metastases or previous history of brain metastases or history of seizures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

307 Hospital of PLA

Beijing, Beijing Municipality, 100071, China

RECRUITING

MeSH Terms

Conditions

Neuroendocrine TumorsCarcinoid TumorAdenoma, Islet Cell

Interventions

Injectionsrecombinant interferon alpha 2b-like protein

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialAdenomaPancreatic NeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Xu Jianming, M.D.

    307 Hospital of PLA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xu Jianming, M.D.

CONTACT

+861051128358jmxu2003@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2015

First Posted

May 28, 2015

Study Start

May 1, 2015

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

January 5, 2016

Record last verified: 2015-10

Locations

CN(1)