Ignite Creation Date:
2024-05-06 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05251948
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2022-02-09
Brief Title:
An Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Gastric or Gastroesophageal Junction Carcinoma
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Phase IbII Open-Label Multicenter Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Gastric or Gastroesophageal Junction Carcinoma MORPHEUS C-Gastric and Gastroesophageal Junction Carcinoma
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:
This is a Phase IbII open-label multicenter randomized umbrella study in participants with advanced gastric carcinoma GC or gastroesophageal junction carcinoma GEJC The study is designed with the flexibility to open new treatment arms as new treatments become available close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity and modify the participant population Cohort 1 will enroll participants with inoperable locally advanced metastatic or advanced GC or GEJC with adenocarcinoma confirmed as the predominant histology who have not received prior systemic therapy for advanced or metastatic disease Eligible participants will initially be randomly assigned to one of treatment arms Stage 1 Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination Stage 2 When a Stage 2 treatment combination is available this will be introduced by amending the protocol
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?:
True
Is an FDA AA801 Violation?:
None