A Phase 1 interventional study of AZD6244 in Tumor and Cancer, sponsored by AstraZeneca. Active, not recruiting at 4 sites in 3 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
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
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Exclusion Criteria:
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 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 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 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 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 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.
Also known as: ARRY-142886
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Day 1 through 11.8 months (maximum observed duration)
Maximum Plasma Concentration (Cmax) of AZD6244 (Part A)
The Cmax of AZD6244 in Part A is reported.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1, 4, 8, and 24 hours post-dose on Day 1 (Part A and Part B) and Day 8 (Part B)
Plan to share: Yes — 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
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