Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT00333502
Status:
COMPLETED
Last Update Posted:
2020-05-28
First Post:
2006-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of CRLX101 (NLG207) in the Treatment of Advanced Solid Tumors
Sponsor:
NewLink Genetics Corporation
Organization:
Study Overview
Official Title:
A Phase 1b/2a Safety and Pharmacokinetic Study of CRLX101 (Formerly Named IT-101) in the Treatment of Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2020-05
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:
CRLX101 is a nanopharmaceutical comprised of the chemotherapeutic camptothecin (CPT) conjugated to a linear, cyclodextrin-based polymer. CRLX101 is designed to increase the exposure of tumor cells to CPT while minimizing side effects.
OBJECTIVES:
• Determine the safety, toxicity, and the maximum tolerated dose (MTD) of CRLX101 when administered intravenously to subjects with advanced solid tumors.
OBJECTIVES:
• Determine the safety, toxicity, and the maximum tolerated dose (MTD) of CRLX101 when administered intravenously to subjects with advanced solid tumors.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| City of Hope IRB number 05127 | None | None | View |