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

NCT01490866 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2019-09-24

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • SCRI Development Innovations, LLC

    lead OTHER

Principal Investigators

  • Johanna Bendell, M.D. · SCRI Development Innovations, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01490866 on ClinicalTrials.gov