Browse
Submit Data
Databases
API
Help

Dataset Information

0 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

ONO-4538/CA2099X8 Phase 2/3 Study(ONO-4538-72/CA2099X8)

ABSTRACT: Interventions: investigational material(s) Generic name etc : ONO-4538/BMS-936558 INN of investigational material : Nivolumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Intravenous administration control material(s) Generic name etc : Fluorouracil, Leucovorin Calcium Folinate, Oxaliplatin, Bevacizumab INN of investigational material : Fluorouracil, Leucovorin Calcium Folinate, Oxaliplatin, Bevacizumab Therapeutic category code : 42- Antineoplastic agents Dosage and Administration for Investigational material : Intravenous administration Primary outcome(s): efficacy PFS Study Design: Randomized, open-label

DISEASE(S): Colorectal Cancer

PROVIDER: 102159 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Json Xml

Similar Datasets

DS-Screen

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

A Randomized Phase III Trial of SOX/Bevacizumab versus FOLFOX/Bevacizmab in Treating Patients with Metastatic Colorectal Cancer (SOFT).

Project description:Interventions: investigational material(s) Generic name etc : S-1 (tegafur + gimeracil + oteracil potassium) INN of investigational material : S-1: tegafur, gimeracil, oteracil potassium Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : 40-60 mg bid day 1 (evening) - day 15 (morning). Repeat cycles every 3 weeks Generic name etc : L-OHP (Oxaliplatin) INN of investigational material : oxaliplatin Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 130 mg/m2 IV on day 1. Repeat cycles every 3 weeks Generic name etc : BV (Bevacizumab) INN of investigational material : bevacizumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 7.5 mg/kg IV on day 1. Repeat cycles every 3 weeks control material(s) Generic name etc : 5-FU (Fluorouracil) INN of investigational material : fluorouracil Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : 400 mg/m2 IV bolus on day 1, followed by 2400 mg/m2 over 46 hours. Repeat cycles every 2 weeks. Generic name etc : l-LV (Levofolinate calcium) INN of investigational material : folic acid Therapeutic category code : 392 Antidotes Dosage and Administration for Investigational material : 200 mg IV on day 1. Repeat cycles every 2 weeks. Generic name etc : L-OHP (Oxaliplatin) INN of investigational material : oxaliplatin Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 85 mg/m2 IV on day 1. Repeat cycles every 2 weeks. Generic name etc : BV (Bevacizumab) INN of investigational material : bevacizumab Therapeutic category code : 429 Other antitumor agents Dosage Primary outcome(s): Progression free survival(PFS) Study Design: Randomized, open-label, comparative study

| 97778 | ecrin-mdr-crc

A prospective observational study of the efficacy and safety of CPT-11 based regimens for UGT1A1 genotype guided patients with metastatic colorectal cancer

Project description:Interventions: investigational material(s) Generic name etc : Irinotecan hydrochloride INN of investigational material : Therapeutic category code : 424 Antineoplastic preparations extracted from plants Dosage and Administration for Investigational material : Approved doses and schedules control material(s) Generic name etc : None INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : None Primary outcome(s): Progression free survival None Study Design: Prospective, cohort

| 97784 | ecrin-mdr-crc

Phase 2 study of DS-8201a in subjects with colorectal cancer [DESTINY-CRC01]

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

A Phase 1 Study of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer

Project description:Interventions: investigational material(s) Generic name etc : OCV-C02 INN of investigational material : - Therapeutic category code : 42- Antineoplastic agents Dosage and Administration for Investigational material : Once-weekly subcutaneous injection (0.3, 1 3 and 6 mg/body) control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : - 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

| 100907 | ecrin-mdr-crc

NK012 phase II clinical study

Project description:Interventions: investigational material(s) Generic name etc : NK012(other antitumor agents) INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Intravenous

| 98783 | ecrin-mdr-crc

Safety comformation study of R435 (Bevacizumab) in patients with metastatic colorectal cancer

Project description:Interventions: investigational material(s) Generic name etc : Bevacizumab INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Injection Primary outcome(s): Safety Study Design: Open, Single Arm study

| 99347 | ecrin-mdr-crc

Phase II Study of S-1 plus LV (1 week on and 1 week off) as First-line Treatment for Patients with metastatic colorectal cancer.

| 99793 | ecrin-mdr-crc

Phase I/II study of R340 (Capecitabine), L-OHP (Oxaliplatin) and R435 (Bevacizumab) in advanced and/or metastatic colorectal cancer

Project description:Interventions: investigational material(s) Generic name etc : Capecitabine|Oxaliplatin|Bevacizumab INN of investigational material : Therapeutic category code : 42- Antineoplastic agents Dosage and Administration for Investigational material : Capecitabine: oral administration Oxaliplatin and Bevacizumab: injection Primary outcome(s): Response Rate, Safety Study Design: Open, Single Arm study

| 99396 | ecrin-mdr-crc

Phase I/II study of R435 (Bevacizumab) in patients with metastatic colorectal cancer

| 99192 | ecrin-mdr-crc