NCT01625936

CRLX101 Plus Bevacizumab in Advanced RCC

Phase 1b Study Of CRLX 101 (Cerulean) In Combination With Bevacizumab In The Treatment Of Patients With Advanced Renal Cell Carcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1b, dose escalation study of the investigational agent, CRLX101, given in combination with Bevacizumab in patients with advanced renal cell carcinoma. The purpose of this study is to determine the initial safety and effectiveness of this agent in combination with Bevacizumab. The investigators are also trying to determine the best dose level of CRLX101 to give in combination with bevacizumab. About 22 subjects will be enrolled in this study at the University of Pennsylvania.

Detailed description

This is a Phase 1b, dose-escalation study of the investigational agent, CRLX101, given in combination with Bevacizumab in patients with advanced renal cell carcinoma. The purpose of this study is to determine the initial safety and effectiveness of this agent in combination with Bevacizumab. The investigators are also trying to determine the best dose level of CRLX101 to give in combination with Bevacizumab. About 22 subjects will be enrolled in this study at the University of Pennsylvania. This study also involved two sub-studies that will be conducted in a select set of study subjects. This includes investigational cG250 PET/CT scans and paired bone marrow biopsy/aspirate assessments. The IND being requested from the FDA for this study will cover both the use of CRLX 101 as well as the use cG250 in the study sub-study.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	CRLX101 (Cerulean)	CRLX101 is an innovative tumor-targeting nanopharmaceutical.
DRUG	Bevacizumab

Timeline

• Start date: 2012-06-01
• Primary completion: 2017-07-01
• Completion: 2018-07-16
• First posted: 2012-06-22
• Last updated: 2018-08-29

Locations

1 site across 1 country: United States