Clinical trial · Interventional
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
A Phase II, Double Blind, Placebo Controlled, Randomised Study 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFIRI | Drug | FOLFIRI Regimen | ALIAS |
| Vandetanib | Drug | Vandetanib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- 1
- description
- FOLFIRI + placebo vandetanib
- interventionNames
- Drug: FOLFIRI
- type
- EXPERIMENTAL
- label
- 2
- description
- FOLFIRI + low dose vandetanib
- interventionNames
- Drug: Vandetanib
- Drug: FOLFIRI
- type
- EXPERIMENTAL
- label
- 3
- description
- FOLFIRI + high dose vandetanib
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available