A phase 1 PK study of thalidomide
Research type
Research Study
Full title
A phase 1, open-label study to evaluate the pharmacokinetics of thalidomide following multiple oral dosing in subjects with multiple myeloma
IRAS ID
128674
Contact name
Faith Davies
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2012-005529-62
ISRCTN Number
N/A
Research summary
Myeloma, also known as multiple myeloma, is a type of cancer arising from plasma cells which are found in the bone marrow (Bone marrow is the ‘spongy’ material found in the bones that produces blood cells such as white cells, red cells and platelets). Thalidomide Celgene is currently approved by the European Medicines Agency (EMA) to treat multiple myeloma (in combination with melphalan and prednisone) in subjects who have not been previously treated for multiple myeloma.
This study is a phase 1, open-label study to evaluate the pharmacokinetics of thalidomide following multiple oral dosing in subjects with multiple myeloma. The main purpose of this study is to characterise the steady-state pharmacokinetics (PK) of thalidomide when given orally as monotherapy to subjects with multiple myeloma.
The total number of participants will be up to 12 with all participants recruited in the UK.
The study will consist of a screening phase, a baseline phase, a PK phase with a 5-day period of thalidomide treatment (200 mg/day), and end-of-study evaluation on Day 6. For females of child bearing potential (FCBP) there will be a 33 day follow up phase. Subjects will have frequent blood samples drawn for PK assessments on Days 5 and 6 in an inpatient setting. The duration of the study is approximately 61 days, which includes a 28-day screening window. The estimated duration of the clinical phase from first dose to the Day-6 end-of-study evaluations for each subject is 7 days. Each subject will take one 200 mg capsule of thalidomide, once daily from Days 1 to 5.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
13/NE/0163
Date of REC Opinion
9 Jul 2013
REC opinion
Further Information Favourable Opinion