Study With AG-013736 Combined With Chemotherapy And Bevacizumab In Patients With Metastatic Colorectal Cancer

Conditions

• Colorectal Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• bevacizumab — DRUG
  bevacizumab 5 mg/kg every 2 weeks
• AG-013726 — DRUG
  AG-013726 5 mg bid every 2 weeks
• AG-013736 (axitinib) — DRUG
  AG-013736 5 mg bid starting dose

Study Details

To determine the safety and efficacy of AG-013736 in combination with other standard of care medication in patients with first line metastatic colorectal cancer.

Key Dates

First listed

Apr 16, 2007

Start date

Jan 31, 2006

Status verified

Nov 2013

Primary completion

Apr 30, 2012

Completion

Nov 30, 2012

Study Design

Enrollment

187 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: B
  bevacizumab 5 mg/kg every 2 weeks + FOLFOX
• Experimental: C
  AG-013726 5 mg bid+ bevacizumab 2 mg/kg every 2 weeks + FOLFOX
• Experimental: A
  AG-013736 5 mg bid starting dose + FOLFOX

Primary Outcome Measure

Percentage of Participants With Objective Response: Phase 2 [ Time Frame: Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy) ]

Locations (106)

Find similar trials in Daphne, AL

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