Study of CC-223 in patients with advanced solid tumours,NHL or MM
Research type
Research Study
Full title
A Phase 1/2, Multi-Center, Open-Label, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the mTOR Kinase Inhibitor CC-223 Administered Orally to Subjects with Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Multiple Myeloma
IRAS ID
94629
Contact name
Tim Meyer
Sponsor organisation
Celgene Corporation
Eudract number
2010-022442-25
Clinicaltrials.gov Identifier
Research summary
Phase 1/2 study in patients with Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Multiple Myeloma. This is a phase 1/2 study, which means that the study medication has never been administered to humans before. The aim of this study is to assess CC-223 (study medication) is safe and can be tolerated. The study will also evaluate how efficient this medication is. This study consists of two parts: dose escalation (Part A) and dose expansion (Part B). Enrolment to Part A of the study has now closed. The goal of the first part was to test different dose levels of CC-223 in order to find out which ones can be tolerated without serious side effects. Part B will further assess the safety profile of CC-223 and provide preliminary efficacy information. Participants in the UK will be joining Part B of the study. Approximately 160 patients in the United States and in Europe will take part in this study. The study (Part B) consists of screening period (4 weeks before first dose), a continuous dosing period during which the participants will take CC-223 (Capsules) once daily for 28 days in a row. This 28-day period is called a cycle. Safety and preliminary anti-tumour activity will be evaluated after every two cycles of therapy. Treatment will start at 45 mg dose level, based on the safety and PK-PD (biomarker) data from Part A. The participants can continue to receive CC-223 at the dose level assigned in the study as long as they are continuing to derive benefit from treatment as judged by the study doctor. An end of the treatment visit will take place within 21 days of the last dose and a follow up period, 28 days after last dose. During the study, the participants will undergo a number of procedures including physical examination, biopsy and scans (PET, MRI/ or CT).
REC name
London - Westminster Research Ethics Committee
REC reference
12/LO/0118
Date of REC Opinion
3 Apr 2012
REC opinion
Further Information Favourable Opinion