Browse
Submit Data
Databases
API
Help

Dataset Information

40 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

Phase 3 Study of Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil Versus Trifluridine/Tipiracil Single Agent in Participants With Previously Treated Metastatic Colorectal Cancer

ABSTRACT: This is a randomized phase III study with a safety lead-in part in patients with KRAS/ NRAS and BRAF Wild Type metastatic colorectal cancer who have previously received treatment with oxaliplatin, irinotecan, fluoropyrimidines, anti-VEGF agents and anti-EGFR antibodies. The main objective of the safety lead-in part is to assess safety and tolerability of futuximab/modotuximab in combination with trifluridine/tipiracil. The primary objective of the phase III part is to compare Overall Survival of futuximab/modotuximab in combination with trifluridine/tipiracil vs trifluridine/tipiracil monotherapy in patients with tumours that are KRAS/NRAS and BRAF wild-type (WT) (Double negative [DN].

DISEASE(S): Metastatic Colorectal Cancer,Colorectal Cancer,Colorectal Cancer Metastatic,Colorectal Neoplasms

PROVIDER: 2403437 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Json Xml

Similar Datasets

Trifluridine/ Tipiracil Plus Panitumumab Versus Trifluridine/ Tipiracil Plus Bevacizumab as First-line Treatment of Metastatic Colorectal Cancer

Project description:FIRE-8 is a prospective, randomized, open label, multicenter phase II clinical trial. To evaluate the effecacy of trifluridine / tipiracil and panitumumab (Arm A) compared to trifluridine / tipiracil and bevacizumab (Arm B), participants will be randomly assigned to either Arm A or Arm B for the treatment of metastatic colorectal cancer. The primary objectives of this study is to compare the effecacy of treatment with trifluridine / tipiracil plus panitumumab versus trifluridine / tipiracil plus bevacizumab.

| 2386782 | ecrin-mdr-crc

Phase III Study of Trifluridine/Tipiracil in Combination With Bevacizumab vs Trifluridine/Tipiracil Single Agent in Patients With Refractory Metastatic Colorectal Cancer

Project description:This study is designed as an international, open-label, controlled two-arm, randomized phase III comparison study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC.

| 2366035 | ecrin-mdr-crc

Trifluridine/Tipiracil in Combination With Capecitabine and Bevacizumab in Metastatic Colorectal Cancer Patients.

Project description:The aim oh this study is to determine the safety and recommended dose of trifluridine/tipiracil plus capecitabine and bevacizumab combination (part 1, dose escalation phase) and to assess its activity in previously untreated mCRC patients who are deemed not eligible for intensive chemotherapy (part 2, expansion phase).

| 2352790 | ecrin-mdr-crc

Biomarkers of Trifluridine-Tipiracil Efficacy.

Project description:Trifluridine/tipiracil (TAS-102) is a newer generation chemotherapy that has been approved for the later-line treatment of metastatic colorectal and gastric/gastroesophageal adenocarcinomas. The oral drug provides a modest benefit of prolongation of survival over placebo in pretreated patients with these cancers with acceptable toxicity. Studies have shown rare objective responses (2-4%), and the disease control rates were 44% in both colorectal and gastric cancer randomized trials. Thus, the majority of patients progress through treatment and are burdened by toxicities. To better characterize the sub-group of patients with a higher probability of benefit from trifluridine/tipiracil, predictive biomarkers have been sought using data from randomized trials as well as from non-randomized trials and real-world series. Biomarkers examined include clinical characteristics of the patients, laboratory tests, and tumor derived biomarkers. These studies show that early neutropenia on treatment, and ratios of leukocyte subsets, are potential biomarkers able to predict trifluridine/tipiracil benefit. Combinations of laboratory values and clinical characteristics and proteins involved in trifluridine transport and activation have been examined with initial positive results.

| S-EPMC8658167 | biostudies-literature

Trifluridine/Tipiracil Plus Bevacizumab Versus Trifluridine/Tipiracil Monotherapy in Refractory Metastatic Colorectal Cancer

Project description:This study is a retrospective study to compare the efficacy and safety between trifluridine/tipiracil (TAS-102) plus bevacizumab (BEV) with TAS-102 monotherapy in refractory metastatic colorectal cancer (mCRC) from November 2020 to October 2022 at the Hunan Cancer Hospital.

| 60837 | ecrin-mdr-crc

microRNA profiling of trifluridine resistant colorectal cancer cell lines and parental cell lines

Project description:microRNA and mRNA profiling was conducted for parental cell lines and cell lines resistant to trifluridine in 3 colorectal cell lines (DLD-1, HCT-116, RKO). We hypothesized that a detailed comparison between miRNA and mRNA expression might reveal the mechanism for acquired resistant to trifluridine in colorectal cancer.

2017-09-25 | GSE96786 | GEO

mRNA profiling of trifluridine resistant colorectal cancer cell lines and parental cell lines

2017-09-25 | GSE96785 | GEO

Bioequivalence Study of Trifluridine and Tipiracil Tablets in Colorectal Cancer Patients

Project description:Trifluridine and Tipiracil Tablets is a nucleoside anti-metabolic and anti-cancer compound developed by Taiho (Dapeng) Co., Ltd., Japan, for the treatment of advanced colorectal cancer that inoperable resection, and progressed or relapsed after standard treatment. This study mainly evaluates bioequivalence, safety and tolerance of Trifluridine and Tipiracil Tablets in colorectal cancer patients.

| 2307445 | ecrin-mdr-crc

A Study of Trifluridine/ Tipiracil in Chemorefractory mCRC in Greece

Project description:Collection of real world data on the clinical efficacy of trifluridine/ tipiracil (FTD/TPI) in the Greek population.

| 2383608 | ecrin-mdr-crc

Evaluation of Efficacy of Trifluridine/Tipiracil Plus an Anti-IL-1α True Human Antibody Versus Trifluridine/Tipiracil Plus Placebo in Metastatic Colorectal Cancer Patients After Failure of Oxaliplatin, Irinotecan, Fluoropyrimidine

Project description:Unresectable metastatic colorectal cancer (mCRC) remains an incurable disease. After failure of conventional treatments involving fluoropyrimidines, oxaliplatin and irinotecan in combination or not with biotherapies targeting EGFR and VEGF; regorafenib shows a modest improvement in overall survival. Recently, trifluridine/tipiracil has also shown efficacy in phase 3 with an overall survival of around 7 months. Trifluridine/tipiracil has become the standard of care for advanced mCRC in most western countries. However, the objective response rate remains very low and the survival gain remains moderate (+2 months). Therefore, new strategies are needed to ensure that mCRC patients who have received multiple lines of therapy can receive more effective treatments. Based on previous clinical trials on IL-1 inhibition and our preclinical data, IL-1 inhibition may increase the efficacy of trifluridine/tipiracil. The goal is to test whether the addition of XB2001 to trifluridine/tipiracil could be synergistic.

| 2401722 | ecrin-mdr-crc

OmicsDI is part of the ELIXIR infrastructure

OmicsDI is an Elixir interoperability service. Learn more ›

Tweets

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