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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer; Tumor
• Intervention / Treatment: Drug: AZD6244

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands, 6525 GA
    • Research Site
  • Utrecht, Netherlands, 3584 CX
    • Research Site
• United Kingdom
  • Sutton, United Kingdom, SM2 5PT
    • Research Site
• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: ARRY-142886

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Part A and Part B	An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.	Day 1 through 11.8 months (maximum observed duration)
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Part A and Part B	Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of hematology, clinical chemistry, and urinalysis.	Day 1 through 11.8 months (maximum observed duration)
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part A and Part B	Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (blood pressure, oxygen saturation, weight, and pulse rate).	Day 1 through 11.8 months (maximum observed duration)
Number of Participants With Abnormal Echocardiogram (ECHO) Parameters Reported as TEAEs in Part A and Part B	Number of participants with abnormal ECHO parameters reported as TEAEs are reported.	Day 1 through 11.8 months (maximum observed duration)
Number of Participants With Abnormal Electrocardiogram (ECG) Parameters Reported as TEAEs in Part A and Part B	Number of participants with abnormal ECG parameters reported as TEAEs are reported.	Day 1 through 11.8 months (maximum observed duration)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Plasma Concentration (Cmax) of AZD6244 (Part A)	The Cmax of AZD6244 in Part A is reported.	Day 1: Pre-dose (within 30 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose; Day 8: Pre-dose (within 10 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, and 12 hours post-dose
Cmax of AZD6244 (Part B Single Dose)	The Cmax of AZD6244 in Part B is reported. Day 1 and Day 8 in Part B are the first days of two periods in crossover bioavailability assessment of two AZD6244 formulations: capsule versus the free-base suspension.	Days 1 and 8: Pre-dose (within 30 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC) of AZD6244 (Part A)	The AUC of AZD6244 in Part A is reported.	Day 1: Pre-dose (within 30 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose
Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC[0-12]) of AZD6244 (Part A)	The AUC(0-12) of AZD6244 in Part A is reported.	Day 8: Pre-dose (within 10 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, and 12 hours post-dose
AUC of AZD6244 (Part B Single Dose)	The AUC of AZD6244 in Part B is reported. Day 1 and Day 8 in Part B are the first days of two periods in crossover bioavailability assessment of two AZD6244 formulations: capsule versus the free-base suspension.	Days 1 and 8: Pre-dose (within 30 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose
Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Post Dose (AUC[0-24]) of AZD6244 (Part B Single Dose)	The AUC(0-24) of AZD6244 in Part B is reported. Day 1 and Day 8 in Part B are the first days of two periods in crossover bioavailability assessment of two AZD6244 formulations: capsule versus the free-base suspension.	Days 1 and 8: Pre-dose (within 30 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose
Time to Reach Maximum Plasma Concentration (Tmax) of AZD6244 (Part A)	The Tmax of AZD6244 in Part A is reported.	Day 1: Pre-dose (within 30 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose; Day 8: Pre-dose (within 10 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, and 12 hours post-dose
Tmax of AZD6244 (Part B Single Dose)	The Tmax of AZD6244 in Part B is reported. Day 1 and Day 8 in Part B are the first days of two periods in crossover bioavailability assessment of two AZD6244 formulations: capsule versus the free-base suspension.	Days 1 and 8: Pre-dose (within 30 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose
Half-life (t1/2) of AZD6244 (Part A)	The t1/2 of AZD6244 in Part A is reported.	Day 1: Pre-dose (within 30 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose
t1/2 of AZD6244 (Part B Single Dose)	The t1/2 of AZD6244 in Part B is reported. Day 1 and Day 8 in Part B are the first days of two periods in crossover bioavailability assessment of two AZD6244 formulations: capsule versus the free-base suspension.	Days 1 and 8: Pre-dose (within 30 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose
Total Apparent Drug Clearance (CL/F) of AZD6244 (Part A)	The CL/F of AZD6244 in Part A is reported.	Day 1: Pre-dose (within 30 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose; Day 8: Pre-dose (within 10 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, and 12 hours post-dose
CL/F of AZD6244 (Part B Single Dose)	The CL/F of AZD6244 in Part B is reported. Day 1 and Day 8 in Part B are the first days of two periods in crossover bioavailability assessment of two AZD6244 formulations: capsule versus the free-base suspension.	Days 1 and 8: Pre-dose (within 30 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose
Volume of Distribution at Steady State (Vss/F) of AZD6244 (Part A)	The Vss/F of AZD6244 in Part A is reported.	Day 1: Pre-dose (within 30 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose
Vss/F of AZD6244 (Part B Single Dose)	The Vss/F of AZD6244 in Part B is reported. Day 1 and Day 8 in Part B are the first days of two periods in crossover bioavailability assessment of two AZD6244 formulations: capsule versus the free-base suspension.	Days 1 and 8: Pre-dose (within 30 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose
Cmax of N-desmethyl AZD6244 (Part A)	The Cmax of N-desmethyl AZD6244 in Part A is reported.	Day 1: Pre-dose (within 30 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose; Day 8: Pre-dose (within 10 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, and 12 hours post-dose
Cmax of N-desmethyl AZD6244 (Part B Single Dose)	The Cmax of N-desmethyl AZD6244 in Part B is reported. Day 1 and Day 8 in Part B are the first days of two periods in crossover bioavailability assessment of two AZD6244 formulations: capsule versus the free-base suspension.	Days 1 and 8: Pre-dose (within 30 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose
AUC of N-desmethyl AZD6244 (Part A)	The AUC of N-desmethyl AZD6244 in Part A is reported.	Day 1: Pre-dose (within 30 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose
AUC(0-12) of N-desmethyl AZD6244 (Part A)	The AUC(0-12) of N-desmethyl AZD6244 in Part A is reported.	Day 8: Pre-dose (within 10 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, and 12 hours post-dose
AUC of N-desmethyl AZD6244 (Part B Single Dose)	The AUC of N-desmethyl AZD6244 in Part B is reported. Day 1 and Day 8 in Part B are the first days of two periods in crossover bioavailability assessment of two AZD6244 formulations: capsule versus the free-base suspension.	Days 1 and 8: Pre-dose (within 30 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose
AUC(0-24) of N-desmethyl AZD6244 (Part B Single Dose)	The AUC(0-24) of N-desmethyl AZD6244 in Part B is reported. Day 1 and Day 8 in Part B are the first days of two periods in crossover bioavailability assessment of two AZD6244 formulations: capsule versus the free-base suspension.	Days 1 and 8: Pre-dose (within 30 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose
Tmax of N-desmethyl AZD6244 (Part A)	The Tmax of N-desmethyl AZD6244 in Part A is reported.	Day 1: Pre-dose (within 30 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose; Day 8: Pre-dose (within 10 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, and 12 hours post-dose
Tmax of N-desmethyl AZD6244 (Part B Single Dose)	The Tmax of N-desmethyl AZD6244 in Part B is reported. Day 1 and Day 8 in Part B are the first days of two periods in crossover bioavailability assessment of two AZD6244 formulations: capsule versus the free-base suspension.	Days 1 and 8: Pre-dose (within 30 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose
t1/2 of N-desmethyl AZD6244 (Part A)	The t1/2 of N-desmethyl AZD6244 in Part A is reported.	Day 1: Pre-dose (within 30 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose
t1/2 of N-desmethyl AZD6244 (Part B Single Dose)	The t1/2 of N-desmethyl AZD6244 in Part B is reported. Day 1 and Day 8 in Part B are the first days of two periods in crossover bioavailability assessment of two AZD6244 formulations: capsule versus the free-base suspension.	Days 1 and 8: Pre-dose (within 30 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose
Cmax of AZD6244 Amide (Part A)	The Cmax of AZD6244 amide in Part A is reported.	Day 1: Pre-dose (within 30 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose; Day 8: Pre-dose (within 10 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, and 12 hours post-dose
Cmax of AZD6244 Amide (Part B Single Dose)	The Cmax of AZD6244 amide in Part B is reported. Day 1 and Day 8 in Part B are the first days of two periods in crossover bioavailability assessment of two AZD6244 formulations: capsule versus the free-base suspension.	Days 1 and 8: Pre-dose (within 30 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose
AUC(0-12) of AZD6244 Amide (Part A)	The AUC(0-12) of AZD6244 amide in Part A is reported.	Day 8: Pre-dose (within 10 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, and 12 hours post-dose
Area Under the Plasma Concentration-time Curve From Time Zero to 4 Hours Post Dose (AUC[0-4]) of AZD6244 Amide (Part B Single Dose)	The AUC(0-4) of AZD6244 amide in Part B is reported. Day 1 and Day 8 in Part B are the first days of two periods in crossover bioavailability assessment of two AZD6244 formulations: capsule versus the free-base suspension.	Days 1 and 8: Pre-dose (within 30 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose
AUC(0-24) of AZD6244 Amide (Part B Single Dose)	The AUC(0-24) of AZD6244 amide in Part B is reported. Day 1 and Day 8 in Part B are the first days of two periods in crossover bioavailability assessment of two AZD6244 formulations: capsule versus the free-base suspension.	Days 1 and 8: Pre-dose (within 30 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose
Tmax of AZD6244 Amide (Part A)	The Tmax of AZD6244 amide in Part A is reported.	Day 1: Pre-dose (within 30 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose; Day 8: Pre-dose (within 10 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, and 12 hours post-dose
Tmax of AZD6244 Amide (Part B Single Dose)	The Tmax of AZD6244 amide in Part B is reported. Day 1 and Day 8 in Part B are the first days of two periods in crossover bioavailability assessment of two AZD6244 formulations: capsule versus the free-base suspension.	Days 1 and 8: Pre-dose (within 30 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose
Cmax of AZD6244 (Part B Multiple Doses)	The Cmax of AZD6244 in Part B is reported.	Days 15 and 22: Pre-dose (within 10 minutes of dosing); 1, 2, and 4 hours post-dose
Tmax of AZD6244 (Part B Multiple Doses)	The Tmax of AZD6244 in Part B is reported.	Days 15 and 22: Pre-dose (within 10 minutes of dosing); 1, 2, and 4 hours post-dose
AUC(0-4) of AZD6244 (Part B Multiple Doses)	The AUC(0-4) of AZD6244 in Part B is reported.	Days 15 and 22: Pre-dose (within 10 minutes of dosing); 1, 2, and 4 hours post-dose
Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC[0-t]) of AZD6244 (Part B Multiple Doses)	The AUC(0-t) of AZD6244 in Part B is reported.	Days 15 and 22: Pre-dose (within 10 minutes of dosing); 1, 2, and 4 hours post-dose
Cmax of N-desmethyl AZD6244 (Part B Multiple Doses)	The Cmax of N-desmethyl AZD6244 in Part B is reported.	Days 15 and 22: Pre-dose (within 10 minutes of dosing); 1, 2, and 4 hours post-dose
Tmax of N-desmethyl AZD6244 (Part B Multiple Doses)	The Tmax of N-desmethyl AZD6244 in Part B is reported.	Days 15 and 22: Pre-dose (within 10 minutes of dosing); 1, 2, and 4 hours post-dose
AUC(0-4) of N-desmethyl AZD6244 (Part B Multiple Doses)	The AUC(0-4) of N-desmethyl AZD6244 in Part B is reported.	Days 15 and 22: Pre-dose (within 10 minutes of dosing); 1, 2, and 4 hours post-dose
AUC(0-t) of N-desmethyl AZD6244 (Part B Multiple Doses)	The AUC(0-t) of N-desmethyl AZD6244 in Part B is reported.	Days 15 and 22: Pre-dose (within 10 minutes of dosing); 1, 2, and 4 hours post-dose
Cmax of AZD6244 Amide (Part B Multiple Doses)	The Cmax of AZD6244 amide in Part B is reported.	Days 15 and 22: Pre-dose (within 10 minutes of dosing); 1, 2, and 4 hours post-dose
Tmax of AZD6244 Amide (Part B Multiple Doses)	The Tmax of AZD6244 amide in Part B is reported.	Days 15 and 22: Pre-dose (within 10 minutes of dosing); 1, 2, and 4 hours post-dose
AUC(0-4) of AZD6244 Amide (Part B Multiple Doses)	The AUC(0-4) of AZD6244 amide in Part B is reported.	Days 15 and 22: Pre-dose (within 10 minutes of dosing); 1, 2, and 4 hours post-dose
AUC(0-t) of AZD6244 Amide (Part B Multiple Doses)	The AUC(0-t) of AZD6244 amide in Part B is reported.	Days 15 and 22: Pre-dose (within 10 minutes of dosing); 1, 2, and 4 hours post-dose
Percentage Inhibition of Extracellular Signal-regulated Kinase (ERK) Phosphorylation	Percentage inhibition of ERK phosphorylation is reported.	1, 4, 8, and 24 hours post-dose on Day 1 (Part A and Part B) and Day 8 (Part B)

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Emerging Oncology Medical Science Director, MD, AstraZeneca

Publications and helpful links

General Publications

• 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.

Helpful Links

• CSR_redacted_2023
• Study Results

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2007
• Primary Completion (Actual): June 17, 2008
• Study Completion (Estimated): March 26, 2027

Study Registration Dates

• First Submitted: April 18, 2007
• First Submitted That Met QC Criteria: April 19, 2007
• First Posted (Estimated): April 20, 2007

Study Record Updates

• Last Update Posted (Actual): August 24, 2026
• Last Update Submitted That Met QC Criteria: August 21, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Malignancy; Advanced Malignancy; Cancer Eligibility
• Additional Relevant MeSH Terms: Neoplasms; AZD 6244
• Other Study ID Numbers: D1532C00005; 2006-004497-26 (EudraCT Number); 2022-500685-10-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes