An Open-Label Phase 1 Study of Ceralasertib in Japanese Patients With Advanced Solid Malignancies

Advanced Solid Malignancies Clinical Trial

Official title: A Phase 1, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Ceralasertib Administered to Japanese Patients With Advanced Solid Malignancies

Status Active, not recruiting

Clinical Trial Summary

This is a Phase 1, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of ceralasertib in Japanese patients with advanced solid malignancies. Cycle 0 duration is 4 days and each cycle from Cycle 1 has a duration of 28 days.

Clinical Trial Description

<Objectives>

Primary Objective:

To investigate the safety and tolerability of ceralasertib in Japanese patients with advanced solid malignancies

Secondary Objective:

To assess the anti-tumor activity and efficacy of ceralasertib. To characterize the first- and multiple-dose pharmacokinetics of ceralasertib.

Exploratory Objective:

To conduct exploratory research into factors that may be predictive of response or may influence the progression of cancer and/or response (efficacy, tolerability, or safety) to ceralasertib.

<Overall design> This is a Phase 1, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of ceralasertib in Japanese patients with advanced solid malignancies. Cycle 0 duration is 4 days and each cycle from Cycle 1 has a duration of 28 days.

Ceralasertib 240 mg monotherapy in cohort 1 will be orally administered as a single dose at Cycle 0 (Cycle 0 duration is 4 days) Day 1 and twice daily from Day 1 to Day 7 of each 28-day cycle (from Cycle 1). Ceralasertib monotherapy of 160 mg will be orally administered as a single dose at Cycle 0 (Cycle 0 duration is 4 days) Day 1 and twice daily from Day 1 to Day 14 of each 28-day cycle (from Cycle 1), respectively, in cohort 2. Each patient will undergo an DLT evaluation period (Cycle 0 and 1) to have the DLT of ceralasertib determined. Patients will continue with the treatment until disease progression, unacceptable toxicity, or withdrawal from the study.

A minimum of 3 and a maximum of 6 evaluable patients will be enrolled in each cohort ("rolling 6 design"). If no DLT is observed in 3-6 evaluable patients or only 1 DLT is observed in 6 evaluable patients in the current cohort, then transition to the following cohort may occur. If 2 or more patients experience a DLT in each cohort of up to 6 evaluable patients, irrespective of the number of patients enrolled, the dose will be considered not tolerated and recruitment to the current cohort and transition to the following cohort will cease. At the completion of the current cohort, a decision will be made to begin the following cohort based on the SRC review. If no DLT is observed in a 3-6 evaluable patients or only 1 DLT is observed in 6 evaluable patients in a dose setting, the dose is considered tolerated.

Other doses/schedules/combination or cohort expansion may be implemented based on emerging data and the SRC review. ;

Related Conditions & MeSH terms

• Advanced Solid Malignancies
• Neoplasms

• NCT number: NCT05469919
• Study type: Interventional
• Source: AstraZeneca
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: June 9, 2022
• Completion date: December 31, 2024