Ignite Creation Date:
2024-05-06 @ 3:46 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02361723
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2015-01-29
Brief Title:
Phase 1a1b BGB-290 for Advanced Solid Tumors
Sponsor:
BeiGene
Organization:
BeiGene
Study Overview
Official Title:
A Phase 1A1B Open Label Multiple Dose Dose Escalation and Expansion Study to Investigate the Safety Pharmacokinetics Food Effect and Antitumor Activities of BGB-290 in Subjects With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study contains Phase 1A and Phase 1B Phase 1A has Part1 BID Dose Escalation and Part2 QD Dosing Escalation Evaluation of a cohort of at least three participants completing one cycle of treatment at that dose level and dose regimen is required prior to determining the next dose level and dose regimen for the next cohort Phase 1B has PartA BID Dosing Expansion will investigate efficacy in participants with selected tumor types and further evaluate safety and tolerability of BGB 290 at recommended dose for future studies and PartB Food Effect will investigate the food effect on the Pharmacokinetics PK of BGB 290 in participants with advanced solid tumors
Detailed Description:
The study contains Phase 1A and Phase 1B Phase 1A has Part1 BID Dose Escalation and Part2 QD Dosing Escalation Evaluation of a cohort of at least three participants completing one cycle of treatment at that dose level and dose regimen is required prior to determining the next dose level and dose regimen for the next cohort Phase 1B has PartA BID Dosing Expansion will investigate efficacy in participants with selected tumor types and further evaluate safety and tolerability of BGB 290 at recommended dose for future studies and PartB Food Effect will investigate the food effect on the PK of BGB 290 in participants with advanced solid tumors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
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 |
|---|---|---|---|
| 2017-003646-25 | EudraCT Number | None | None |