NCT01490866

A Trial of Single Agent Axitinib as Maintenance Therapy for Patients With First Line Metastatic Colorectal Cancer (mCRC)

A Phase II Trial of Single Agent Axitinib as Maintenance Therapy for Patients With First Line Metastatic Colorectal Cancer (mCRC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a non-randomized, open-label, Phase II trial investigating axitinib as a single-agent maintenance therapy following standard first-line FOLFOX/bevacizumab therapy for patients with mCRC.

Detailed description

All patients will receive FOLFOX/bevacizumab for four 28-day cycles (a total of 16 weeks). After 4 cycles, maintenance axitinib will be started. With approval of the Medical Monitor,patients who are having significant benefit from FOLFOX/bevacizumab may continue chemotherapy to a maximum of six 28-day cycles. During trial treatment, all patients will be assessed for response every 8 weeks (2 cycles).

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Axitinib	5-mg tablets PO BID
DRUG	Bevacizumab	5 mg/kg Days 1 and 15; IV
DRUG	5-Fluorouracil	400 mg/m2 Days 1 and 15; IV
DRUG	5-Fluorouracil	2400 mg/m2 over 46-48 hours Days 1 and 15; Continuous Intravenous
DRUG	Leucovorin	400 mg/m2 Days 1 and 15; IV
DRUG	Oxaliplatin	85 mg/m2 Days 1 and 15; IV

Timeline

• Start date: 2012-01-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2011-12-13
• Last updated: 2019-09-24
• Results posted: 2017-01-12

Locations

12 sites across 1 country: United States