Trials Sponsors Conditions Drugs Pricing

Conditions

Nerve Sheath Tumor

Keywords

MEKNF2nerve sheath tumor

Outcome Measures

Primary Outcomes (1)

Objective response rate (ORR) estimated by investigators
Investigator-assessed objective mitigation rate ORR (Reponse evaluation in Nerufibromatosis and Schwannomatosis, REiNS criteria and RECIST 1.1 criteria, respectively)
Every 4 cycles (each cycle is 28 days), assessed up to 2 years

Secondary Outcomes (5)

Clinical benefit rate (CBR) estimated by investigators
Every 4 cycles (each cycle is 28 days), assessed up to 2 years
24-week word recognition score (WRS)
up to 24 weeks
pain estimated by NRS
Every 4 cycles (each cycle is 28 days), assessed up to 2 years
Duration of response (DOR) assessed by investigator
From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
progression free survival (PFS) assessed by investigator
From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

Other Outcomes (2)

life quality assessed by NFTI-QOL
Every 4 cycles (each cycle is 28 days), assessed up to 2 years
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0
During the intervention

Study Arms (1)

FCN-159

EXPERIMENTAL

FCN-159 8mg qd po

Drug: FCN-159

Interventions

FCN-159Drug

FCN-159 8mg qd po

FCN-159

Eligibility Criteria

Age16 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

≥16 years of age, regardless of gender.
meet the revised 2022 diagnostic criteria for NF2-associated nerve sheath tumors or pathologically confirmed NF2-associated nerve sheath tumors.

Sponsors & Collaborators

Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Otherlead

Study Sites (1)

Shuhang Wang

Beijing, Beijing Municipality, 100021, China

RECRUITING

Shuhang WangCONTACT13581809307

MeSH Terms

Conditions

Nerve Sheath Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasmsPeripheral Nervous System NeoplasmsNervous System NeoplasmsNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular Diseases

Study Officials

Shuhang wang, PhD
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
STUDY DIRECTOR

Central Study Contacts

Ning Li, M.D.

CONTACT

+86 135-5271-5820 yalejiang@cicams.ac.cn

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

August 3, 2024

First Posted

August 14, 2024

Study Start

August 15, 2024

Actual (reported)

Primary Completion

July 31, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Phase II Study of FCN-159 in NF2 Nerve Sheath Tumors

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Other Outcomes (2)

Study Arms (1)

FCN-159

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Other Outcomes (2)

Study Arms (1)

FCN-159

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations