Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-03-05 @ 4:33 AM
Study NCT ID:
NCT03792958
Status:
UNKNOWN
Last Update Posted:
2022-11-14
First Post:
2018-12-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Challenge Meditech 082 (CM082) Tablets in Patients With Advanced Malignant Solid Tumors
Sponsor:
AnewPharma
Organization:
Study Overview
Official Title:
Phase I Study of CM082 Tablets in the Treatment of Advanced Malignant Solid Tumors: Safety, Tolerance and Pharmacokinetics
Status:
UNKNOWN
Status Verified Date:
2022-11
Last Known Status:
ACTIVE_NOT_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 is a Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Oral Dosing of CM082 tablets in Chinese Patients With Advanced Malignant Solid Tumors
Detailed Description:
This is a single-center、open-label and non-controlled Phase 1 study which will be conducted in two parts: part A is the dose-escalation phase; part B is dose-expansion phase. The dose-escalation phase is guided by pharmacokinetics (PK) and safety, according to the standard 3+3 dose-escalation schema. CM082 tablets are taken orally with a starting dose of 200 mg and a subsequent dose of 400, 600 and 800 mg. The way of administration is as follows: QD or BID. The primary objective of this study is to determine the maximum tolerable dose (MTD)、characteristics of dose-limited toxicity (DLT) and pharmacokinetics (PK). Secondary objectives include safety、tolerability and preliminary efficacy
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: