NCT02398747

Japanese Phase I Study of AZD2014 in Advanced Solid Malignancies

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD2014 Administered to Japanese Patients With Advanced Solid Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to investigate the safety and tolerability of continuous and/or intermittent dosing of AZD2014 when given orally to patients with advanced solid malignancies.

Detailed description

This is an open-label, multi-centre study of AZD2014 administered orally in Japanese patients with advanced solid malignancies. The study design allows an evaluation of each cohort with intensive safety monitoring to ensure the safety of the patients. In this study, a minimum of 3 and a maximum of 6 evaluable patients will be enrolled in each cohort; approximately 24 evaluable patients in total. The total number of patients enrolled will depend upon the number of screen failures, number of cohorts and number of evaluable subjects. Safety, preliminary efficacy and PK (single and multiple dose) are evaluated in this study. Patients will receive a single dose of AZD2014 on Day 1 (to allow assessment of single dose PK), then after a minimum of 48 hours washout period continuous or intermittent twice daily dosing of AZD2014 will be initiated. The washout period of 48 hours may be extended depending on emerging data from previous cohorts.Doses and schedules to be evaluated will be agreed by AstraZeneca and the Safety Review Committee (SRC).

Conditions

• Advanced Solid Malignancies

Interventions

Type	Name	Description
DRUG	AZD2014	50mg continuous dosing, 125mg intermittent dosing, 25 mg and 50mg intermittent dosing with weekly Paclitaxel

Timeline

• Start date: 2015-03-17
• Primary completion: 2024-04-12
• Completion: 2024-04-12
• First posted: 2015-03-25
• Last updated: 2024-12-17

Locations

2 sites across 1 country: Japan