Ignite Creation Date:
2024-05-06 @ 3:17 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02252211
Status:
COMPLETED
Last Update Posted:
2022-10-12
First Post:
2014-09-22
Brief Title:
Safety and Bioimaging Trial of DS-8895a in Patients With Advanced EphA2 Positive Cancers
Sponsor:
Ludwig Institute for Cancer Research
Organization:
Ludwig Institute for Cancer Research
Study Overview
Official Title:
A Phase I Safety and Bioimaging Trial of DS-8895a in Patients With Advanced or Metastatic EphA2 Positive Cancers
Status:
COMPLETED
Status Verified Date:
2022-10
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:
LUD2014-002
Brief Summary:
This was a Phase 1 dose-escalation non-randomized open-label single-center study of DS-8895a in patients with advanced or metastatic Ephrin type-A receptor 2 EphA2-positive cancers The primary study objective was to determine the safety of DS-8895a with secondary objectives of determining the biodistribution tumor uptake bioimaging pharmacokinetics PK antitumor and pharmacodynamic response and correlations between pharmacodynamics and clinical outcomes as appropriate
Detailed Description:
Patients received an initial 89Zr trace-labelled infusion of DS-8895a on Day 1 followed by safety assessments positron emission tomography PET imaging and PK sampling over a 1-week period DS-8895a was infused again on Days 8 22 and 36 The Day 36 infusion of DS-8895a was also trace labelled with 89Zr with subsequent PET imaging and PK sampling Four dose levels 1 3 10 and 20 mgkg were to be evaluated with 3 to 6 patients entered at each dose level Patients who responded or had stable disease per the Response Evaluation Criteria in Solid Tumors RECIST version 11 at the Day 50 restaging may have continued to receive biweekly treatment with DS-8895a until disease progression with restaging performed by computed tomography CT scans every 6 weeks
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