Tasquinimod in patients with advanced/ metastatic HCC,GC,OAC and RCC
Research type
Research Study
Full title
A multicentre, open label, early stopping design, proof of concept study with tasquinimod in treating patients with advanced or metastatic hepatocellular, ovarian, renal cell and gastric carcinomas.
IRAS ID
112288
Contact name
Elizabeth Ruth Plummer
Contact email
Sponsor organisation
Ipsen Pharma
Eudract number
2012-002326-75
ISRCTN Number
N/A
Research summary
This is an early phase, exploratory proof of concept study to determine the clinical activity of tasquinimod in patients with advanced metastatic hepatocellular, ovarian, renal cell and gastric carcinomas will be included. The clinical activity of tasquinimod will be evaluated separately in cohorts of patients of the four different tumour types. Patients would have an initial screening period of up to 4 weeks (Days-28 to -1) followed by a treatment period (Day 1 until disease progression, loss to follow up, withdrawal or death). An end of study visit will take place at least 14 days after the last dose of study treatment. Patients will be followed for survival until death, lost to follow up, withdrawal of consent or for at least 9 months after last treatment. Patients with gastric carcinoma will have visits on weeks 2, 4, 6 12, 18 and week 24 (and every 8 weeks thereafter). Patients with hepatocellular carcinomas, ovarian and renal carcinomas will have visits on weeks 2, 4, 8, 16 and 24 (and every 8 weeks thereafter). Blood and urine samples will be taken for routine laboratory testing (Biochemistry and haematology) biomarker testing and pharmacokinetics. Tumour imaging will take place during screening and every 8 weeks while patients are on study (every 6 weeks for patients with gastric carcinomas). Liver biopsies will also be carried out during screening and at week 4 for hepatocellular, ovarian and renal patients.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
12/NE/0333
Date of REC Opinion
27 Sep 2012
REC opinion
Favourable Opinion