A Phase 1 Study in Patients with Advanced or Metastatic Cancer (JJCA)
Research type
Research Study
Full title
A Phase 1 Study of LY3039478 in Patients with Advanced or Metastatic Cancer
IRAS ID
154358
Contact name
Debashis Sarker
Contact email
Sponsor organisation
Eli Lilly & Company
Eudract number
2012-001854-24
Research summary
Notch signalling plays a key role in the normal development of many tissues in the body and faulty Notch signalling is implicated in a number of cancers. LY3039478 is a new drug being developed to inhibit Notch signalling and provide therapeutic benefits to cancer patients.
I6F-MC-JJCA is a Phase 1 study in patients with advanced or metastatic cancer. The study will be conducted in 2 parts with the UK participating only in Part B. The purpose of the study is to determine a recommended dose of LY3039478 by evaluating the safety of the drug and the side effects on the body.For Part B, outpatients with advanced or metastatic cancer will receive a pre-determined dose of oral LY3039478 during 28-day cycles. Patients will undergo 2 cycles of treatment unless the criteria for discontinuation are fulfilled and may receive more than 2 cycles if the investigator determines that the patient is experiencing clinical benefit from treatment.
Study assessments will include Physical examinations, blood tests, skin tissue samples and radiological assessments (X-ray, CT, MRI or PET scans).
REC name
London - Central Research Ethics Committee
REC reference
14/LO/1336
Date of REC Opinion
24 Oct 2014
REC opinion
Further Information Favourable Opinion