AZD6244 (ARRY-142886) Solid Oral Dosage Formulation in Participants With Advanced Solid Malignancies
NCT ID: NCT00463814
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
58 participants
INTERVENTIONAL
2007-03-08
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A: Dose Escalation AZD6244 25 mg
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.
AZD6244
Participants will receive single oral dose of AZD6244 as described in arm description.
Part A: Dose Escalation AZD6244 50 mg
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.
AZD6244
Participants will receive single oral dose of AZD6244 as described in arm description.
Part A: Dose Escalation AZD6244 75 mg
Participants will receive a single oral dose of AZD6244 75 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.
AZD6244
Participants will receive single oral dose of AZD6244 as described in arm description.
Part A: Dose Escalation AZD6244 100 mg
Participants will receive a single oral dose of AZD6244 100 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.
AZD6244
Participants will receive single oral dose of AZD6244 as described in arm description.
Part B: Relative Bioavailability (Sequence 1) and Safety Assessment Phase
Participants in relative bioavailability phase will receive a single oral dose of AZD6244 100 mg free-base suspension (mix and drink) on Day 1. Following a washout period of 7 days, participants will receive a single oral dose of AZD6244 75 mg capsule on Day 8 (Sequence 1). In the safety assessment phase, participants who will participate in the relative bioavailability phase will receive oral AZD6244 75 mg capsule bd dosing from Day 9 onwards until disease progression or another protocol-defined discontinuation criterion will be met, whichever will occur first.
AZD6244
Participants will receive single oral dose of AZD6244 as described in arm description.
Part B: Relative Bioavailability (Sequence 2) and Safety Assessment Phase
Participants in relative bioavailability phase will receive a single oral dose of AZD6244 75 mg capsule on Day 1. Following a washout period of 7 days, participants will receive a single oral dose of AZD6244 100 mg free-base suspension (mix and drink) on Day 8 (Sequence 2). In the safety assessment phase, participants who will participate in the relative bioavailability phase will receive oral AZD6244 75 mg capsule bd dosing from Day 9 onwards until disease progression or another protocol-defined discontinuation criterion will be met, whichever will occur first.
AZD6244
Participants will receive single oral dose of AZD6244 as described in arm description.
Interventions
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AZD6244
Participants will receive single oral dose of AZD6244 as described in arm description.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* World Health Organization (WHO) performance status 0 to 2
* evidence of post-menopausal status or negative pregnancy test
Exclusion Criteria
* 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
18 Years
99 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Emerging Oncology Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Aurora, Colorado, United States
Research Site
Nijmegen, , Netherlands
Research Site
Utrecht, , Netherlands
Research Site
Sutton, , United Kingdom
Countries
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References
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Boers-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.
Related Links
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Other Identifiers
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2022-500685-10-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2006-004497-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D1532C00005
Identifier Type: -
Identifier Source: org_study_id