AZD6244 (ARRY-142886) Solid Oral Dosage Formulation in participants with Advanced Solid Malignancies
Study identifier:D1532C00005
ClinicalTrials.gov identifier:NCT00463814
EudraCT identifier:2006-004497-26
CTIS identifier:2022-500685-10-00
Recruitment Complete
Official Title
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
Medical condition
Tumor
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD6244
Sex
All
Actual Enrollment
58
Study type
Interventional
Age
18 Years - 99 Years
Date
Study Start Date: 08 Mar 2007
Primary Completion Date: 17 Jun 2008
Estimated Study Completion Date: 31 Dec 2024
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Sequential Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 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. | Drug: AZD6244 Participants will receive single oral dose of AZD6244 as described in arm description. Other Name: ARRY-142886 |
| Experimental: 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. | Drug: AZD6244 Participants will receive single oral dose of AZD6244 as described in arm description. Other Name: ARRY-142886 |
| Experimental: 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. | Drug: AZD6244 Participants will receive single oral dose of AZD6244 as described in arm description. Other Name: ARRY-142886 |
| Experimental: 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. | Drug: AZD6244 Participants will receive single oral dose of AZD6244 as described in arm description. Other Name: ARRY-142886 |
| Experimental: 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. | Drug: AZD6244 Participants will receive single oral dose of AZD6244 as described in arm description. Other Name: ARRY-142886 |
| Experimental: 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. | Drug: AZD6244 Participants will receive single oral dose of AZD6244 as described in arm description. Other Name: ARRY-142886 |
Contacts
Investigators
Principal Investigator
Emerging Oncology Medical Science Director
AstraZeneca
