Clinical trial · Interventional
Randomised Study to Compare the Efficacy of AZD6244 vs TMZ
A Phase II, Multi-centre, Open-Label, Parallel Group, Randomised Study To Compare the Efficacy of AZD6244 vs Temozolomide in Patients With Unresectable AJCC Stage 3 or 4 Malignant Melanoma
NCT00338130CI-TRIAL-00015377completedPhase 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 primary purpose of this study is to compare the efficacy of AZD6244 (ARRY-142886) with temozolomide in patients with advanced melanoma
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 |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AZD6244 | Drug | Selumetinib | ALIAS |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Temozolomide
- interventionNames
- Drug: Temozolomide
- type
- EXPERIMENTAL
- label
- 2
- description
- AZD6244
- interventionNames
- Drug: AZD6244
Primary outcomes (4)
- measure
- To compare the efficacy of AZD6244 vs temozolomide in patients with unresectable AJCC stage 3 or 4 malignant melanoma by assessing progression free survival (PFS)
- timeFrame
- From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with late stage malignant melanoma * Aged 18 or over * Female patients must be post-menopausal or with negative urine pregnancy test if pre-menopausal Exclusion Criteria: * Any previous radiotherapy or chemotherapy (palliative radiotherapy is acceptable) * Participation in any other trial with an investigational product within the previous 30 days
References
Publications (0)
Data not yet available
No reference posted for this study.