Ignite Creation Date:
2025-12-18 @ 8:16 AM
Ignite Modification Date:
2025-12-23 @ 9:56 PM
Study NCT ID:
NCT04687423
Status:
None
Last Update Posted:
2021-08-18 00:00:00
First Post:
2020-12-10 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of FCN-011 in Patients With Advanced Solid Tumor（Phase I）and NTRK Fusion Positive Advanced Solid Tumor （Phase II）
Sponsor:
None
Organization:
Study Overview
Official Title:
A Multicenter, Open, Single-arm Phase I Dose Exploration and Phase II Extended Study Was Conducted to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Primary Antitumor Activity of FCN-011 in Patients With Advanced Solid Tumor (Phase I) and NTRK Fusion Positive Advanced Solid Tumor (Phase II)
Status:
None
Status Verified Date:
2021-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a multicenter, open, single-arm Phase I/II clinical study, which is divided into two research parts, namely phase I dose exploration study and phase II dose extension study. In the phase I dose exploration study, the safety, tolerance and PK characteristics of FCN-011 in patients with advanced solid tumors were determined, the MTD of oral fCN-011 was determined, and the RP2D of FCN-011 in the phase II clinical study was determined, and the efficacy of FCN-011 was preliminarily evaluated. The phase II dose extension study evaluated the efficacy, safety, and tolerability of continuous oral ADMINISTRATION of FCN-011 in patients with inoperable NTRK fusion and advanced stage III or IV solid tumors, as well as the characteristics of population pharmacokinetics (PopPK).
A total of 35-82 patients were enrolled in this study, 15-24 patients were expected to be enrolled in the phase I study, and 20-58 patients were expected to be enrolled in the phase II study.
A total of 35-82 patients were enrolled in this study, 15-24 patients were expected to be enrolled in the phase I study, and 20-58 patients were expected to be enrolled in the phase II study.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: