Phase 1a/1b BGB-290 for Advanced Solid Tumors.
NCT02361723 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 101
Last updated 2024-12-27
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.
Conditions
- For Participants With Advanced Solid Tumors Failed With Previous Lines of Treatment
Interventions
- DRUG
-
BGB-290
- DRUG
-
BGB-290
- DRUG
-
BGB-290
- DRUG
-
BGB-290
- DRUG
-
BGB-290
Sponsors & Collaborators
-
BeiGene
lead INDUSTRY
Principal Investigators
-
Michael Millward, MD · Linear Clinical Research
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-07-03
- Primary Completion
- 2019-09-03
- Completion
- 2019-09-03
Countries
- Australia
Study Locations
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