NCT03980821

A Phase I Study of AZD4635 in Japanese Patients With Advanced Solid Malignancies

A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD4635 in Japanese Patients With Advanced Solid Malignancies.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 20 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I, open-label study to assess the safety, tolerability, pharmacokinetics and anti-tumor activity of AZD4635 in Japanese patients with advanced solid malignancies. This study consists of 2 cohorts, Cohort1 and Cohort2. At least 3 or up to 6 evaluable Japanese patients with advanced solid malignancies will be enrolled in Cohort1 and 6 evaluable patients will be enrolled in Cohort2.

Detailed description

Objectives: Primary objective: Investigate the safety and tolerability of AZD4635 monotherapy in Japanese patients Secondary objective: Characterize the single-dose and multiple-dose plasma pharmacokinetic (PK) parameters of AZD4635 monotherapy Determine the preliminary anti-tumor activity of AZD4645 monotherapy Overall design: This is a phase I, open-label study of AZD4635 in Japanese patients with advanced solid malignancies. The study consists of 2 cohorts, Cohort 1 and Cohort 2. At least 3 or up to 6 evaluable Japanese subjects with advanced solid malignancies will be enrolled in Cohort 1 and 6 evaluable patients will be required for Cohort 2 to confirm the tolerability. The total number of evaluable subjects in each cohort will depend upon available data in each cohort and decision of Safety Review Committee(SRC). Study Period: The study is expected to start in June 2019 and end in June 2020. Number of Subjects: 9 to 12 evaluable subjects will be enrolled in this study to confirm the tolerability. Treatments and treatment duration: Subjects will receive AZD4635 once daily (QD). A single dose of AZD4635 will be taken on Cycle 0 Day1 and the subsequent dose of AZD4635 will be taken from Cycle 1 Day 1 until discontinuation criterion is met. A cycle of study treatment will be defined as 21 days of continuous dosing.

Conditions

• Advanced Solid Malignancies

Interventions

Type	Name	Description
DRUG	AZD4635	AZD4635 taken orally

Timeline

• Start date: 2019-07-04
• Primary completion: 2020-09-07
• Completion: 2020-09-07
• First posted: 2019-06-10
• Last updated: 2020-12-08

Locations

2 sites across 1 country: Japan