Ignite Creation Date:
2024-05-06 @ 9:30 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT02999672
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2016-12-19
Brief Title:
A Study to Determine Best Tumor Response With Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2 HER2 Overexpressing Solid Tumors
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
Phase II Exploratory Multicenter Non Randomized Single Agent Cohort Study to Determine Best Tumor Response With Trastuzumab Emtansine in HER2 Overexpressing Solid Tumors
Status:
COMPLETED
Status Verified Date:
2019-07
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:
KAMELEON
Brief Summary:
This multicenter non-randomized Phase II study will assess the efficacy safety and pharmacokinetics of trastuzumab emtansine in participants with HER2 overexpressing locally advanced unresectable and not treatable with curative intent or metastatic urothelial bladder cancer UBC locally advanced unresectable and not treatable with curative intent or metastatic pancreatic cancercholangiocarcinoma with advanced disease where cure is no longer possible and where no other treatment options are available anymore Participants will receive intravenous IV infusion of trastuzumab emtansine as Regimen A 24 milligrams per kilogram mgkg weekly qw or Regimen B 36 mgkg every 3 weeks q3w until unacceptable toxicity withdrawal of consent disease progression PD or death whichever occurs first Based on tolerability and safety aspects steering committee and Independent Data Monitoring Committee iDMC will decide on expansion of the study to include more participants with other carcinoma types
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 2015-001377-40 | EUDRACT_NUMBER | None | None |