Viewing Study NCT02900651



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Last Modification Date: 2024-10-26 @ 12:09 PM
Study NCT ID: NCT02900651
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-06-20
First Post: 2016-09-02

Brief Title: Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies
Sponsor: Novartis Pharmaceuticals
Organization: Novartis

Study Overview

Official Title: A Phase III Multicenter Open-label Study of MAK683 in Adult Patients With Advanced Malignancies
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
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: The purpose of this Phase III study is to establish the maximum tolerated dose MTD andor recommended phase 2 dose RP2D and to evaluate the safety antitumor activity and pharmacokinetic PK profile of MAK683 in patients with advanced malignancies such as Diffuse Large B cell Lymphoma DLBCL nasopharyngeal carcinoma NPC or other advanced solid tumors for whom no further effective standard treatment is available
Detailed Description: The purpose phase I of this trial is to characterize safety and tolerability and determine the maximum tolerated dose MTD andor recommended phase 2 dose RP2D of MAK683

The purpose of the phase II of this trial is to evaluate the anti-tumor activity of MAK683 Phase II part will not be opened

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
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?: None
Secondary IDs
Secondary ID Type Domain Link
2016-001860-12 EUDRACT_NUMBER None None