NCT00333502

Study of CRLX101 (NLG207) in the Treatment of Advanced Solid Tumors

A Phase 1b/2a Safety and Pharmacokinetic Study of CRLX101 (Formerly Named IT-101) in the Treatment of Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: NewLink Genetics Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Solid Tumor

Interventions

Type	Name	Description
DRUG	Camptothecin (CPT) conjugated to a linear, cyclodextrin-based polymer	Subjects who meet inclusion/exclusion criteria will receive CRLX101 every other week.

Timeline

• Start date: 2006-05-01
• Primary completion: 2011-11-01
• Completion: 2012-04-01
• First posted: 2006-06-05
• Last updated: 2020-05-28

Locations

3 sites across 1 country: United States