Ignite Creation Date:
2024-05-06 @ 2:01 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01953926
Status:
TERMINATED
Last Update Posted:
2024-03-12
First Post:
2013-09-26
Brief Title:
Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
Sponsor:
Puma Biotechnology Inc
Organization:
Puma Biotechnology Inc
Study Overview
Official Title:
An Open-Label Phase 2 Basket Study of Neratinib in Patients With Solid Tumors With Somatic Activating HER Mutations
Status:
TERMINATED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated to align with the sponsors current development plans for neratinib The decision was not based on any new efficacy or safety data for neratinib
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUMMIT
Brief Summary:
This is an open-label multicenter multinational Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER EGFR HER2 mutation-positive solid tumors
Detailed Description:
This is an open-label multicenter multinational Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER EGFR HER2 mutation-positive solid tumors The study has a basket design and includes several cohorts either defined by an actionable somatic mutation or by actionable mutation and tumor histology including HER2 mutant breast HER2 mutant cervical HER2 mutant salivary gland and EGFR Exon 18 mutant Non-small cell lung cancers
The trial will consist of a screening period a treatment period and an end of treatment visit occurring when neratinib is discontinued for any reason a safety follow-up visit occurring 28 days after the last dose of neratinib and a survival follow-up period
The trial will consist of a screening period a treatment period and an end of treatment visit occurring when neratinib is discontinued for any reason a safety follow-up visit occurring 28 days after the last dose of neratinib and a survival follow-up period
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 |
|---|---|---|---|
| 2013-002872-42 | EUDRACT_NUMBER | None | None |