Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-25 @ 5:19 PM
Study NCT ID:
NCT01115803
Status:
TERMINATED
Last Update Posted:
2019-02-05
First Post:
2010-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of LY2584702 With Erlotinib or Everolimus in Participants With Solid Tumors
Sponsor:
Eli Lilly and Company
Organization:
Study Overview
Official Title:
A Phase 1b Trial of LY2584702 in Combination With Erlotinib or Everolimus in Patients With Solid Tumors
Status:
TERMINATED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Primary objective has been met; safety and pharmacokinetics have been characterized.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study I3G-MC-JGCB (JGCB) is a multicenter, nonrandomized, open-label, dose-escalation Phase 1b study of LY2584702 in combination with either erlotinib or everolimus.
Detailed Description:
Study JGCB will consist of the following parts:
Part 1 - Dose Escalation to maximum tolerated dose in each arm.
Arm A - LY2584702 + Erlotinib in participants with advanced or metastatic cancer.
Arm B - LY2584702 + Everolimus in participants with advanced or metastatic cancer.
Part 2 - Dose Confirmation of maximum tolerated dose from each arm in Part 1.
Arm A - LY2584702 + Erlotinib in participants with advanced or metastatic non-small cell lung cancer.
Arm B - LY2584702 + Everolimus in participants with advanced renal cell carcinoma after treatment failure with sunitinib or sorafenib, or advanced neuroendocrine tumors.
Part 1 - Dose Escalation to maximum tolerated dose in each arm.
Arm A - LY2584702 + Erlotinib in participants with advanced or metastatic cancer.
Arm B - LY2584702 + Everolimus in participants with advanced or metastatic cancer.
Part 2 - Dose Confirmation of maximum tolerated dose from each arm in Part 1.
Arm A - LY2584702 + Erlotinib in participants with advanced or metastatic non-small cell lung cancer.
Arm B - LY2584702 + Everolimus in participants with advanced renal cell carcinoma after treatment failure with sunitinib or sorafenib, or advanced neuroendocrine tumors.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| I3G-MC-JGCB | OTHER | Eli Lilly and Company | View |