Clinical trial · Interventional
Phase II Efficacy Study of AZD6244 in Colorectal Cancer
A Phase II, Open, Randomized Study to Assess the Efficacy and Safety of AZD6244 vs Capecitabine (Xeloda) in Patients With Colorectal Cancer Who Have Failed One or Two Prior Chemotherapeutic Regimens.
NCT00514761CI-TRIAL-00015384completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 the study is to assess if there is benefit when using AZD6244 in the treatment if metastatic colorectal cancer in comparison with another treatment called capecitabine. This study will also assess how safe and well tolerated AZD6244 is.
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 |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AZD6244 | Drug | Selumetinib | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Xeloda
- interventionNames
- Drug: Capecitabine
- type
- EXPERIMENTAL
- label
- 2
- description
- AZD6244
- interventionNames
- Drug: AZD6244
Primary outcomes (1)
- measure
- Progression event count
- timeFrame
- assessed after each visit
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * colorectal cancer * require treatment but have failed one or two previous chemotherapeutic regimens that must have included oxaliplatin and/or irinotecan * have World Health Organisation (WHO) performance status 0-2 and life expectancy \> 12 weeks Exclusion Criteria: * previous therapy with EGFR inhibitor, MEK inhibitor or capecitabine * any recent surgery, unhealed surgical incision or severe concomitant condition which makes it undesirable for the patient to participate in the study * nausea and vomiting, chronic gastrointestinal disease or significant bowel resection that would preclude adequate absorption
References
Publications (0)
Data not yet available
No reference posted for this study.