NCT03096054

A CR-UK Phase I Trial of LY3143921

A Cancer Research UK (CR-UK) Phase I Trial of LY3143921 a Cdc7 Inhibitor in Adult Patients with Advanced Solid Tumours

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Cancer Research UK · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical study is looking at a drug called LY3143921 hydrate (a Cdc7 inhibitor) in adult patients with advanced solid tumours. The main aims are to find out the maximum dose of LY3143921 hydrate that can be given safely to patients, more about the potential side effects and how they can be treated

Detailed description

This clinical study is looking at a drug called LY3143921 hydrate (a Cdc7 inhibitor). Cdc7 helps our cells replicate correctly. In normal cells, Cdc7 is usually found at a low level, but can reach higher levels in cancer cells. This is often the case in certain types of solid tumour cancers, which we will focus on in this study. It is thought that giving LY3143921 hydrate will block the function of Cdc7 and will affect cancer cells by stopping their replication and causing them to die. LY3143921 hydrate looks promising in laboratory studies and studies in animals. This clinical study has two parts: Part 1 - a 'dose escalation' phase where groups of patients will receive increasing doses of LY3143921 hydrate to find a safe dose and a dose that best targets the cancer cells. This part of the trial is now closed. Part 2 - an 'expansion' phase where a larger group of patients will receive the highest dose of LY3143921 hydrate considered to be safe from Part 1, to find out more about how the drug is working.

Conditions

• A. Colorectal Cancer
• B. High Grade Serous Ovarian Cancer
• C. Non Small-cell Lung Cancer (squamous Cell Variant)
• D. Squamous Carcinoma of the Oesophagus
• E. Squamous Carcinoma of the Head and Neck (HPV Negative)
• F. Urothelial Cancer
• G. Breast Cancer (triple Negative Type)
• H. Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	LY3143921 hydrate	LY3143921 hydrate will be administered orally on a daily schedule. Each cycle of treatment will consist of 21 days, and patients may initially receive up to 12 cycles. If the patient is benefitting, they may continue beyond 12 cycles.

Timeline

• Start date: 2017-06-21
• Primary completion: 2027-02-28
• Completion: 2027-02-28
• First posted: 2017-03-30
• Last updated: 2024-12-17

Locations

4 sites across 1 country: United Kingdom