Browse
Submit Data
Databases
API
Help

Dataset Information

12 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

A Randomized, Double-Blind, Multicenter Phase 3 Study of Irinotecan, Folinic Acid, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab or Placebo in Patients With Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy With Bevacizumab,Oxaliplatin, and a Fluoropyrimidine

ABSTRACT: Intervention name : Ramucirumab Dosage And administration of the intervention : Either ramucirumab DP (8 mg/kg) or placebo (a volume equivalent to that of ramucirumab DP), administered as an IV infusion over 60 (+10) minutes on Day 1 of each cycle; then a 1-hour observation period following the initial and second infusions of investigational product; followed by the FOLFIRI regimen indicated in the following bullets Intervention name : Irinotecan (IRI) Dosage And administration of the intervention : 180 mg/m2 administered intravenously over 90 (±10) minutes, 1 hour after the end of the infusion of investigational product (or immediately after the infusion of investigational product if no observation period is required) on Day 1 of each cycle; followed by Intervention name : Folinic acid (FA) Dosage And administration of the intervention : 400 mg/m2 administered intravenously over 120 (±10) minutes on Day 1 of each cycle; followed by Intervention name : 5-Fluorouracil (5-FU) Dosage And administration of the intervention : 400 mg/m2 bolus over 2 to 4 minutes administered intravenously immediately following completion of the FA infusion on Day 1 of each cycle; followed by 5-Fluorouracil (5-FU): 2400 mg/m2 administered intravenously over 46 to 48 hours (continuously) on Days 1 and 2 of each cycle Control intervention name : null

DISEASE(S): Colorectal Cancer

PROVIDER: 2610580 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Json Xml

Similar Datasets

A multicenter, single-arm, phase II study of ramucirumab plus FOLFIRI with 150 mg/m2 irinotecan, standard Nippon dose, as the second-line treatment for Japanese patients with metastatic colorectal cancer

Project description:Interventions: FOLFIRI plus ramucirumab treatment ramucirumab : administered intravenously at a dose of 8 mg/kg over 60 minutes on day 1. l-leucovorin: administered intravenously at a dose of 200 mg/m2 over 120 minutes on day 1. irinotecan: administered intravenously at a dose of 150 mg/m2 over 90 minutes on day 1. bolus 5-fluorouracil: administered by rapid intravenous infusion at a dose of 400 mg/m2 on day 1. infusional 5-fluorouracil: administered by continuous intravenous infusion at a dose of 2400 mg/m2 over 46 hours from days 1 to 3. Primary outcome(s): progression-free survival (PFS) Study Design: Single arm Non-randomized

| 2640889 | ecrin-mdr-crc

A phase I study of TAS-102 and irinotecan

Project description:Intervention name : TAS-102 Dosage And administration of the intervention : TAS-102 as a starting dose of 25 mg/m2/dose BID (50 mg/m2/day) is administered orally in a 28-day cycle (2-week cycle of 5 days of treatment followed by a 2-day rest period, and then a 14-day rest period). Control intervention name : irinotecan INN of the control intervention : irinotecan Dosage And administration of the control intervention : Irinotecan is administered by intravenous infusion at a dose of 150 mg/m2 over 90 minutes on day 1 and 15. Primary outcome(s): Safety CTCAE (ver.3.0) Study Design: Open-label, multi-center, phase I study

| 2610898 | ecrin-mdr-crc

A clinical trial to study the safety and efficacy of biosimilar Bevacizumab in patients with metastatic colorectal cancer.

Project description:Intervention1: Biosimilar Bevacizumab: Dosage Form: It will be supplied in concentration of 25 mg/ml single dose vial for injection Dose: 7.5 mg/kg intravenously every 3 weeks for a total of 4 cycles. The initial dose (Cycle 1) should be delivered over 90 minutes as an intravenous infusion. If the first infusion (Cycle 1) is well tolerated, the second infusion (Cycle 2) may be administered over 60 minutes. If the 60-minute infusion is well tolerated, all subsequent infusions may be administered over 30 minutes. Control Intervention1: Innovator Bevacizumab: Dosage Form: It will be supplied in concentration of 25 mg/ml single dose vial for injection Dose: 7.5 mg/kg intravenously every 3 weeks for a total of 4 cycles. The initial dose (Cycle 1) should be delivered over 90 minutes as an intravenous infusion. If the first infusion (Cycle 1) is well tolerated, the second infusion (Cycle 2) may be administered over 60 minutes. If the 60-minute infusion is well tolerated, all subsequent infusions may be administered over 30 minutes. Primary outcome(s): To compare the efficacy of Biosimilar Bevacizumab versus Innovator Bevacizumab, both in Combination with CAPEOX in patients with metastatic colorectal cancer (mCRC) by assessment of best Overall Response Rate (ORR)Timepoint: All patients completed 12 week of treatment. Study Design: Randomized, Parallel Group, Active Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

| 2596365 | ecrin-mdr-crc

A Study Of PF-05212384 plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS and NRAS Wild Type Metastatic Colorectal Cancer

Project description:Intervention name : Drug: PF-05212384 Drug: Irinotecan Dosage And administration of the intervention : PF-05212384: 30 minute IV infusion of PF-05212384 110 mg on days 2, 9, 16 and 23 of each cycle Irinotecan: 90 minutes IV infusion of irinotecan 180mg/m2 on days 1 and 15 of each cycle Control intervention name : Drug: Cetuximub Drug: irinotecan Dosage And administration of the control intervention : Cetuximab: 120 minute IV infusion of cetuximab 400 mg/m2 on cycle 1 day 1; 60 minute IV infusion of cetuximab 250 mg/m2 on day 8, 15, and 22 of each cycle and on day of each cycle after cycle 1. Irinotecan: 90 minutes IV infusion of irinotecan 180mg/m2 on days 1 and 15 of each cycle Primary outcome(s): PFS Study Design: Open, 2 arm, randomized controlled trial

| 2611015 | ecrin-mdr-crc

A phase I study of TAS-102 and irinotecan

Project description:Interventions: investigational material(s) Generic name etc : TAS-102 INN of investigational material : Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : TAS-102 as a starting dose of 25 mg/m2/dose BID (50 mg/m2/day) is administered orally in a 28-day cycle (2-week cycle of 5 days of treatment followed by a 2-day rest period, and then a 14-day rest period). control material(s) Generic name etc : irinotecan INN of investigational material : irinotecan Therapeutic category code : 424 Antineoplastic preparations extracted from plants Dosage and Administration for Investigational material : Irinotecan is administered by intravenous infusion at a dose of 150 mg/m2 over 90 minutes on day 1 and 15. Primary outcome(s): Safety CTCAE (ver.3.0) Study Design: Open-label, multi-center, phase I study

| 100929 | ecrin-mdr-crc

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

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

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.

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 : S-1 40-60 mg x 2/day was administered orally for one week followed by one week rest. Intervention name : LV (Levofolinate calcium) INN of the intervention : folic acid Dosage And administration of the intervention : LV 25 mg x 2/day was administered orally for one week along with S-1 followed by one week rest. Primary outcome(s): Efficacy, Safety Study Design: Open-label, Multi-center Study

| 2610136 | ecrin-mdr-crc

Phase II Study of SOL and Bevacizumab Combination Therapy in patients with Untreated Metastatic Colorectal Cancer.

Project description:Intervention name : S-1(tegafur + gimeracil + oteracil potassium)/LV/L-OHP/Bevacizumab INN of the intervention : S-1:tegafur, gimeracil, oteracil potassium LV:folic acid OHP:oxaliplatin Bevacizumab:bevacizumab Dosage And administration of the intervention : S-1 40-60 mg bid day 1-day 7, LV 25 mg bid day 1-day 7, L-OHP 85 mg/m2 iv. for 2 hr on day 1 of each 2 weeks cycle, Bevacizumab 5 mg/kg iv. for 90 min on day 1 of each 2 weeks cycle. Control intervention name : null Primary outcome(s): Response rate(RR) RECIST Study Design: Randomized, open-label, comparative study.

| 2610204 | ecrin-mdr-crc

Phase 2/3 study of fluoropyrimidine and irinotecan plus bevacizumab versus trifluridine/tipiracil plus bevacizumab as second-line for metastatic colorectal cancer (TRUSTY)

Project description:Intervention name : trifluridine/tipiracil INN of the intervention : trifluridine/tipiracil Dosage And administration of the intervention : Trifluridine/tipiracil was given in a dose of 35-75 mg twice daily (after breakfast and dinner) (70-150 mg/day) from after dinner on Day 1 to after breakfast on Day 6 and from after dinner on Day 8 to after breakfast on Day 13. Treatment was given orally for 5 consecutive days followed by a 2-day rest. This treatment was repeated twice, followed by a 14-day rest. This 28-day cycle was repeated until the criteria for withdrawal of the study treatment were met. Intervention name : bevacizumab INN of the intervention : bevacizumab Dosage And administration of the intervention : Bevacizumab 5 mg/kg was given as a 30-min continuous intravenous infusion on Day 1 and Day 15. Control intervention name : fluorouracil INN of the control intervention : fluorouracil Dosage And administration of the control intervention : [Treatment with FOLFIRI + bevacizumab] Fluorouracil 400 mg/m2 was given by rapid intravenous injection on Day 1, followed by a 46-h continuous intravenous infusion of 2400 mg/m2. Each cycle was 14 days, and treatment was repeated until the criteria for withdrawal of the study treatment were met. Control intervention name : TS-1(tegafur + gimeracil + oteracil potassium) INN of the control intervention : TS-1(tegafur + gimeracil + oteracil potassium) Dosage And administration of the control intervention : [Treatment with TS-1+ irinotecan +bevacizumab (3-week cycles) ] TS-1 is given orally in a dose of 40-60 mg twice daily (after breakfast and dinner) in accordance with body-surface area (80-120 mg/day), starting from after dinner on Day 1 to after breakfast on Day 15, followed by a 7-day rest. Each cycle was 21 days, and treatmen Primary outcome(s): efficacy Overall survival Study Design: Randomized, open-label, comparative study

| 2611617 | ecrin-mdr-crc

Phase 1 study of CS-7017 in combination with FOLFIRI

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

OmicsDI is part of the ELIXIR infrastructure

OmicsDI is an Elixir interoperability service. Learn more ›

OmicsDI Databases

PRIDE
PeptideAtlas
MassIVE
JPOST Repository
Physiome Model Repository

EGA
EVA
ENA
LINCS
PAXDB
Cell Collective

MetaboLights
Metabolomics Workbench
MetabolomeExpress
GNPS
BioModels
FAIRDOMHub

ArrayExpress
dbGaP
ExpressionAtlas
GEO
NODE

Information

Databases
Help
API
Contact us
Code on GitHub
Terms of use
Submit Data