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Brief Title: Phase I / II Study of Enadenotucirev by Sub-acute Fractionated IV Dosing in Cancer Patients
Official Title: A Clinical Study Of Enadenotucirev Administered by Sub-Acute Fractionated Intravenous Injection: Dose Escalation in Metastatic Epithelial Solid Tumours and Randomised Controlled Trial in Metastatic Colorectal Cancer
Study ID: NCT02028442
Brief Summary: This is a multicentre, open-label, Phase I/II study of enadenotucirev in patients with either solid tumour of epithelial origin not responding to standard therapy or for whom no standard treatment exists (Phase I dose escalation stage Single cycle), mCRC not responding to standard therapy (Phase I dose escalation Repeat cycle cohort expansion stage ), mCRC not responding to standard therapy or advanced or metastatic bladder cancer not candidate for chemotherapy (Phase Ib) or mCRC in stable disease or partial response after 3-4 months of first line standard of care chemotherapy (Phase II).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
GZA ziekenhuizen campus Sint-Augustinus, Wilrijk, Antwerp, Belgium
Cliniques Universitaires St Luc, Bruxelles, , Belgium
Ghent University Hospital, Ghent, , Belgium
Institut Catala d Oncologica, Barcelona, , Spain
START - Hospital Universitario Madrid Sanchinarrio, Madrid, , Spain
Hospital Universitario Virgen del Rocio (HUVR), Seville, , Spain