NCT03669601

AZD6738 & Gemcitabine as Combination Therapy

A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Ascending Doses of Combined Therapy With ATR Inhibitor AZD6738 and Gemcitabine, Using a Model Based Design.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: CCTU- Cancer Theme · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

A dose escalation trial to assess the safety of AZD6738 in combination with gemcitabine in participants with advanced solid tumours.

Detailed description

A phase 1, non-randomised, multicentre, model-based dose escalation trial. This trial will assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of ascending doses of combined therapy with ATR inhibitor (AZD6738) and gemcitabine, in participants with advanced solid tumours, followed by an expansion phase in participants with advanced pancreatic ductal adenocarcinoma (PDAC).

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	AZD6738	A potent, selective inhibitor of the serine/threonine-specific protein kinase, ataxia telangiectasia and Rad3-related protein (ATR), with good selectivity against other phosphatidylinositol 3-kinase-related kinase (PIKK) family members.
DRUG	Gemcitabine	Nucleoside metabolic inhibitor.

Timeline

• Start date: 2019-10-15
• Primary completion: 2023-09-30
• Completion: 2024-09-30
• First posted: 2018-09-13
• Last updated: 2021-06-04

Locations

1 site across 1 country: United Kingdom