Phase 2
Completed N=106
A Phase II, Double Blind Study of 2 Doses of ZACTIMA™(ZD6474) in Combination With FOLFIRI vs FOLFIRI Alone for the Treatment of Colorectal Cancer in Patients
Source: ClinicalTrials.gov NCT00454116 ↗Enrolled (actual)
106
Serious AEs
31.1%
Results posted
May 2011
Primary outcomePrimary: Number of Patients With an Objective Disease Progression Event — 20; 24; 24 Participants
Summary
The purpose of this study is to assess the efficacy and safety of 2 doses of ZACTIMA™ (ZD6474) in combination with FOLFIRI vs FOLFIRI alone for the treatment of colorectal cancer in patients who have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With an Objective Disease Progression Event |
20; 24; 24 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed colorectal cancer
- Have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen defined as:
- Progression on or following treatment for metastatic colorectal cancer
- Progression within 12 months of adjuvant chemotherapy for colorectal cancer
Exclusion Criteria
- Previous treatment with small molecule tyrosine kinase inhibitors of VEGFR or EGFR eg, erlotinib, gefitinib. Prior monoclonal antibodies are permitted, eg, cetuximab, bevacizumab.
- Previous adjuvant therapy with irinotecan within 12 months of randomization
- More than one prior course of chemotherapy for treatment of metastatic colorectal cancer.
Data sourced from ClinicalTrials.gov (NCT00454116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.