Viewing Study NCT00333502



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Last Modification Date: 2024-10-26 @ 9:25 AM
Study NCT ID: NCT00333502
Status: COMPLETED
Last Update Posted: 2020-05-28
First Post: 2006-06-01

Brief Title: Study of CRLX101 NLG207 in the Treatment of Advanced Solid Tumors
Sponsor: NewLink Genetics Corporation
Organization: Lumos Pharma

Study Overview

Official Title: A Phase 1b2a 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
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
City of Hope IRB number 05127 None None None