Ignite Creation Date:
2024-05-06 @ 11:14 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03469557
Status:
COMPLETED
Last Update Posted:
2020-09-30
First Post:
2018-02-08
Brief Title:
BGB A317 in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable Locally Advanced or Metastatic Esophageal Gastric or Gastroesophageal Junction Carcinoma
Sponsor:
BeiGene
Organization:
BeiGene
Study Overview
Official Title:
A Phase 2 Multi-Cohort Study to Investigate the Safety Pharmacokinetics and Preliminary Antitumor Activity of the Anti-PD-1 Monoclonal Antibody BGB A317 in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable Locally Advanced or Metastatic Esophageal Gastric or Gastroesophageal Junction Carcinoma
Status:
COMPLETED
Status Verified Date:
2024-10
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:
This is a Phase 2 multi-cohort study to investigate safety PK and preliminary anti-tumor activity of the monoclonal antibody BGB A317 in combination with standard chemotherapy as first-line treatment Cohorts include an ESCC cohort and a gastric carcinoma GC or GEJ carcinoma cohort that will be enrolled concurrently The study includes a screening up to 28 days treatment until disease progression intolerable toxicity or treatment withdrawal for another reason safety follow-up up to 30 days following last study drug treatment and survival follow-up phase
Detailed Description:
The study includes an initial phase during which 6 subjects will be enrolled in each cohort ESCC and GCGEJ carcinoma Safety data will be reviewed by a Safety Monitoring Committee SMC after the first 6 subjects in a cohort have completed at least 1 cycle 21 days of treatment During the initial phase subjects who discontinue for a reason unrelated to safety before completing Cycle 1 will be replaced If there are no new significant or severe safety signals detected the enrollment will be expanded up to approximately 15 subjects per cohort treatment expansion During the treatment expansion subjects will not be replaced for any reason
In the ESCC cohort subjects will be treated with BGB A317 200 mg IV on Day 1 cisplatin 80 mgm² IV on Day 1 and 5-FU 800 mgm²day IV using continuous pumping system on Days 1 through 5 during each 21-day cycle Cisplatin and 5-FU will be given for up to 6 cycles and BGB A317 will be administered until disease progression intolerable toxicity or treatment discontinuation for any other reason
In the GC and GEJ carcinoma cohort subjects will be treated with BGB A317 200 mg IV on Day 1 oxaliplatin 130 mgm² IV on Day 1 and capecitabine 1000 mgm² orally twice daily bid Days 1 through 14 14 days total during each 21-day cycle Oxaliplatin will be administered for up to 6 cycles and capecitabine and BGB A317 will be administered until disease progression intolerable toxicity or treatment discontinuation for any other reason
In the ESCC cohort subjects will be treated with BGB A317 200 mg IV on Day 1 cisplatin 80 mgm² IV on Day 1 and 5-FU 800 mgm²day IV using continuous pumping system on Days 1 through 5 during each 21-day cycle Cisplatin and 5-FU will be given for up to 6 cycles and BGB A317 will be administered until disease progression intolerable toxicity or treatment discontinuation for any other reason
In the GC and GEJ carcinoma cohort subjects will be treated with BGB A317 200 mg IV on Day 1 oxaliplatin 130 mgm² IV on Day 1 and capecitabine 1000 mgm² orally twice daily bid Days 1 through 14 14 days total during each 21-day cycle Oxaliplatin will be administered for up to 6 cycles and capecitabine and BGB A317 will be administered until disease progression intolerable toxicity or treatment discontinuation for any other reason
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTR20170515 | REGISTRY | ChiCTR | None |