Ignite Creation Date:
2024-05-06 @ 1:16 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
Study NCT ID:
NCT01774786
Status:
COMPLETED
Last Update Posted:
2020-12-30
First Post:
2013-01-21
Brief Title:
A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 HER2-Positive Metastatic Gastroesophageal Junction or Gastric Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Randomized Multicenter Phase III Study Evaluating the Efficacy and Safety of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Metastatic Gastroesophageal Junction and Gastric Cancer
Status:
COMPLETED
Status Verified Date:
2020-12
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:
JACOB
Brief Summary:
This double-blind placebo-controlled randomized multicenter international parallel arm study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab fluoropyrimidine and cisplatin as first-line treatment in participants with HER2-positive metastatic gastroesophageal junction GEJ or gastric cancer GC Participants will be randomized to receive pertuzumab 840 milligrams mg or placebo intravenously every 3 weeks q3w in combination with trastuzumab initial dose of 8 milligrams per kilogram mgkg intravenously IV followed by 6 mgkg IV q3w and cisplatin and fluoropyrimidine capecitabine or 5-fluorouracil for the first 6 treatment cycles Participants will continue to receive pertuzumab or placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason
Detailed Description:
None
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 |
|---|---|---|---|
| 2012-003554-83 | EUDRACT_NUMBER | None | None |