DS-Screen
Ontology highlight
ABSTRACT:
PROVIDER: 2611525 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
Similar Datasets
Project description:Interventions: investigational material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : -
control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -
Primary outcome(s): exploratory
FGFR2 and HER2 protein expression
IHC
Study Design: Observational study
| 98039 | ecrin-mdr-crc
Project description:Intervention name : DS-8201a
INN of the intervention : trastuzumab deruxtecan
Dosage And administration of the intervention : IV solution (Once every 3 weeks, 6.4 mg/kg)
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Primary outcome(s): efficacy
The objective response rate
RECIST Version 1.1
Study Design: multi center, open-label, 3-cohort study
| 2658293 | ecrin-mdr-crc
Project description:Intervention name : S-1 (tegafur + gimeracil + oteracil potassium)
INN of the intervention : S-1: tegafur, gimeracil, oteracil potassium
Dosage And administration of the intervention : 40-60 mg bid day 1 (evening) - day 15 (morning). Repeat cycles every 3 weeks
Intervention name : L-OHP (Oxaliplatin)
INN of the intervention : oxaliplatin
Dosage And administration of the intervention : 130 mg/m2 IV on day 1. Repeat cycles every 3 weeks
Intervention name : BV (Bevacizumab)
INN of the intervention : bevacizumab
Dosage And administration of the intervention : 7.5 mg/kg IV on day 1. Repeat cycles every 3 weeks
Control intervention name : 5-FU (Fluorouracil)
INN of the control intervention : fluorouracil
Dosage And administration of the control intervention : 400 mg/m2 IV bolus on day 1, followed by 2400 mg/m2 over 46 hours. Repeat cycles every 2 weeks.
Control intervention name : l-LV (Levofolinate calcium)
INN of the control intervention : folic acid
Dosage And administration of the control intervention : 200 mg IV on day 1. Repeat cycles every 2 weeks.
Control intervention name : L-OHP (Oxaliplatin)
INN of the control intervention : oxaliplatin
Dosage And administration of the control intervention : 85 mg/m2 IV on day 1. Repeat cycles every 2 weeks.
Control intervention name : BV (Bevacizumab)
INN of the control intervention : bevacizumab
Dosage And administration of the control intervention : 5 mg/kg IV on day 1. Repeat cycles every 2 weeks.
Primary outcome(s): Progression free survival(PFS)
Study Design: Randomized, open-label, comparative study
| 2610116 | ecrin-mdr-crc
Project description:Intervention name : ONO-4538/BMS-936558
INN of the intervention : Nivolumab
Dosage And administration of the intervention : Intravenous administration
Control intervention name : Fluorouracil, Leucovorin Calcium Folinate, Oxaliplatin, Bevacizumab
INN of the control intervention : Fluorouracil, Leucovorin Calcium Folinate, Oxaliplatin, Bevacizumab
Dosage And administration of the control intervention : Intravenous administration
Primary outcome(s): efficacy
PFS
Study Design: Randomized, open-label
| 2658327 | ecrin-mdr-crc
Project description:Interventions: investigational material(s)
Generic name etc : DS-8201a
INN of investigational material : trastuzumab deruxtecan
Therapeutic category code : 42- Antineoplastic agents
Dosage and Administration for Investigational material : IV solution (Once every 3 weeks, 6.4 mg/kg)
control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -
Primary outcome(s): efficacy
The objective response rate
RECIST Version 1.1
Study Design: multi center, open-label, 3-cohort study
| 102108 | ecrin-mdr-crc
Project description:Intervention name : Encorafenib, Binimetinib
INN of the intervention : encorafenib, binimetinib
Dosage And administration of the intervention : Encorafenib will be administered on a QD schedule and binimetinib will be administered on a BID schedule
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Primary outcome(s): safety, efficacy
-
Study Design: A Multicenter, Single arm, Open-label Study
| 2612052 | ecrin-mdr-crc
Project description:Intervention name : OCV-C02
INN of the intervention : -
Dosage And administration of the intervention : Once-weekly subcutaneous injection (0.3, 1 3 and 6 mg/body)
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Primary outcome(s): safety
Dose Limiting Toxicity (DLT)
Common Terminology Criteria for Adverse Events (CTCAE), ver. 4.0
Study Design: multicenter, open, non-comparative study
| 2657927 | ecrin-mdr-crc
Project description:Intervention name : YHI-1003
INN of the intervention : Perifosine
Dosage And administration of the intervention : oral
Control intervention name : null
Primary outcome(s): safety
CTCAE v4.0
Study Design: open-label, multicenter trial
| 2610657 | ecrin-mdr-crc
Project description:Intervention name : Cabozantinib Malate
INN of the intervention : Cabozantinib
Dosage And administration of the intervention : Cabozantinib: 40 mg or 60 mg, once daily at bedtime, oral, in a 28 day-course.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Primary outcome(s): safety, efficacy
- Proportion of subjects with DLT (phase 1 part)
- Confirmed ORR by investigators’ assessment in patients who received study treatment as 3rd line or later (phase 2 part)
Study Design: An open-label, single arm phase I study and an open-label, randomized controlled multicenter phase II study
| 2611903 | ecrin-mdr-crc
Project description:Intervention name : CS-7017
INN of the intervention : efatutazone
Dosage And administration of the intervention : CS-7017(0.25-0.50 mg) administered orally twice a day
Control intervention name : null
Primary outcome(s): Safety and Pharmacokinetics
-To evaluate the safety profile according to CTCAE
-To evaluate the pharmacokinetics according to the protocol
Study Design: Open Label Phase 1 Study
| 2610363 | ecrin-mdr-crc