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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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The primary purpose of the study is to assess the safety, tolerability and pharmacokinetics of a capsule of AZD6244 in patients with advanced solid malignancies.

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

CTIS Number

EudraCT Number

NCT ID

Patient Level Data

Therapeutic Area

Research Site

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

Age Continuous

Sex: Female, Male

Race/Ethnicity, Customized

Any AE

Any causally related AE

Any AE of CTC grade>=3

Any causally related AE of CTC grade>=3

Any SAE

Any causally related SAE

Any AE with outcome of death

Any causally related AE with outcome of death

Total AEs

AZD6244 Cmax (Part A Day1)

AZD6244 Cmax (Part A Day 8)

Day1 and Day8 in Part B are the first days of two periods in crossover bioavailability assessment of two AZD6244 formulations: Hyd-Sulfate capsule versus the free-base suspension

Evaluate exposure difference between two formulations

AZD6244 Cmax (Part B Single dose)

AZD6244 AUC (Part A Day1)

AZD6244 AUC0-12 (Part A Day 8)

AZD6244 AUC (Part B Single dose)

AZD6244 AUC0-24 (Part B Single dose)

AZD6244 Tmax (Part A Day1)

AZD6244 Tmax (Part A Day8)

Evaluate difference between two formulations

AZD6244 Tmax (Part B Single dose)

N-desmethyl AZD6244 Cmax (Part A Day1)

N-desmethyl AZD6244 Cmax (Part A Day 8)

N-desmethyl AZD6244 Cmax (Part B Single dose)

N-desmethyl AZD6244 AUC (Part A Day1)

N-desmethyl AZD6244 AUC0-12 (Part A Day 8)

N-desmethyl AZD6244 AUC (Part B Single dose)

N-desmethyl AZD6244 AUC0-24 (Part B Single dose)

N-desmethyl AZD6244 Tmax (Part A Day1)

N-desmethyl AZD6244 Tmax (Part A Day8)

N-desmethyl AZD6244 Tmax (Part B Single dose)

Inhibition (%) of ERK phosphorylation (1 Hour)

Inhibition (%) of ERK phosphorylation (4 Hour)

Inhibition (%) of ERK phosphorylation (8 Hour)

Inhibition (%) of ERK phosphorylation (24 Hour)

Complete Response (CR)

Stable Disease >= 6 weeks (SD>=6 weeks)

Progressive Disease (PD)

Not Evaluable (NE)

Safety population who had measurable disease at baseline

Objective Tumor Response

Overall Study

Total 64 patients were enrolled (informed consent) and 59 were randomised. There were 4 incorrect enrolments.

Karen So

AZD6244 (ARRY-142886) Solid Oral Dosage Formulation in patients 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

Documents available

CSR_redacted_2023

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator