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

Study drug

AZD6244

Sex

All

Actual Enrollment

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 2025

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Sequential Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2025 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Sutton, United Kingdom, SM2 5PT

Location

Research Site

Nijmegen, Netherlands, 6525 GA

Location

Research Site

UTRECHT, Netherlands, 3584 CX

Location

Research Site

Aurora, CO, United States, 80045

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

Documents available

Download
CSR_redacted_2023
Download
Study Results
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Contact Backup

AstraZeneca Information (Outside

001-800-236-9933

Investigators

Principal Investigator

Emerging Oncology Medical Science Director

AstraZeneca

AZD6244 (ARRY-142886) Solid Oral Dosage Formulation in participants with Advanced Solid Malignancies

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Documents available

CSR_redacted_2023

Study Results

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator