Ignite Creation Date:
2024-05-06 @ 9:07 AM
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
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 |