Clinical trial · Interventional
AZD6244 (ARRY-142886) Solid Oral Dosage Formulation in Participants With Advanced Solid Malignancies
A Phase I, Open-Label, Multi-centre Study to Assess the Safety, Tolerability and Pharmacokinetics of a Solid Oral Dosage Formulation (Capsule) of AZD6244 in Patients With Advanced Solid Malignancies
NCT00463814CI-TRIAL-00123376active not recruitingPhase 1ClinicalTrials.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 the study is to assess the safety, tolerability and pharmacokinetics of a capsule of AZD6244 in participants with advanced solid malignancies
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AZD6244 | Drug | Selumetinib | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Part A: Dose Escalation AZD6244 25 mg
- description
- Participants will receive a single oral dose of AZD6244 25 mg capsule on Day 1 followed by continuous twice daily (bd) dosing from Day 2 onwards, until disease progression or another protocol-defined discontinuation criterion will be met, whichever will occur first.
- interventionNames
- Drug: AZD6244
- type
- EXPERIMENTAL
- label
- Part A: Dose Escalation AZD6244 50 mg
- description
- Participants will receive a single oral dose of AZD6244 50 mg capsule on Day 1 followed by continuous dosing from Day 2 onwards, until disease progression or another protocol-defined discontinuation criterion will be met, whichever will occur first.
- interventionNames
- Drug: AZD6244
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * cancer which is refractory to standard therapies * World Health Organization (WHO) performance status 0 to 2 * evidence of post-menopausal status or negative pregnancy test Exclusion Criteria: * Radiotherapy/chemotherapy within 21 days prior to entry * brain metastases/spinal cord compression unless stable off steroids/anticonvulsants * evidence of severe/uncontrolled systemic disease * participated in an investigational drug study within 30 days
References
Publications (1)
- DERIVEDBoers-Sonderen MJ, Desar IM, Blokx W, Timmer-Bonte JN, van Herpen CM. A prolonged complete response in a patient with BRAF-mutated melanoma stage IV treated with the MEK1/2 inhibitor selumetinib (AZD6244). Anticancer Drugs. 2012 Aug;23(7):761-4. doi: 10.1097/CAD.0b013e328350737d. PMID 22293660