WHO ICTRP trial

An open phase II study of safety, tolerability, highest tolerable dose and…

EUCTR2019-003779-20-DE · EU Clinical Trials Register · Authorised

Key facts

Trial ID EUCTR2019-003779-20-DE
Public title An open phase II study of safety, tolerability, highest tolerable dose and anti-tumor effect of SCO-101 in combination with FOLFIRI as a safe and effective treatment of patients with widespread colorectal cancer who has developed treatment resistance to treatment with FOLFIRI
Scientific title An?open-label phase II prospective clinical trial to?investigate safety, tolerability, maximum tolerated dose and anti-tumor?effect for SCO-101 in combination with?FOLFIRI?as?a safe and efficient treatment modality?in metastatic or advanced colorectal cancer (mCRC) patients with…
Primary sponsor Scandion Oncology A/S
Registry EU Clinical Trials Register
Recruitment status Authorised
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries Spain;Denmark;Germany
Conditions Metastatic or advanced colorectal cancer (mCRC) with acquired resistance to chemotherapy? MedDRA version: 21.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864 ;Therapeutic area…
Interventions Product Name: SCO-101 Product Code: SCO-101 Pharmaceutical Form: Tablet INN or Proposed INN: SCO-101 CAS Number: 265646-85-3 Current Sponsor code: SCO-101 Other descriptive name: N-[4-bromo-2-(1H-1,2,3,4-tetrazol-5-yl)phenyl]-N'-[3,5…
Registration date Oct 29, 2021
Target size 35
Secondary IDs SCO101-001;2019-003779-20-DK
Registry page clinicaltrialsregister.eu

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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