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A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer

ABSTRACT: This is an international multi-center, prospective, open-label, randomized, adaptive design phase 3 trial of the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus standard bi-weekly FOLFIRI in patients with previously treated metastatic colorectal cancer (CRC).

DISEASE(S): Metastatic Colorectal Cancer,Histologically Confirmed Adenocarcinoma Of The Colon Or Rectum That Is Metastatic (stage Iv).,Colorectal Cancer,Colorectal Neoplasms,Neoplasms

PROVIDER: 2213684 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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A Phase III Clinical Study of Napabucasin (GB201) Plus FOLFIRI in Adult Patients With Metastatic Colorectal Cancer

Project description:This is a randomized, open-label, multi-center, phase III study of Napabucasin plus bi-weekly FOLFIRI (Arm 1) vs. Napabucasin (Arm 2) for adult patients with metastatic CRC who have failed standard chemotherapy regimens. For patients who have failed bevacizumab with irinotecan-based chemotherapies (treatment failure is defined as radiologic progression of disease during or within 3 months following the last dose), bevacizumab maybe administered in combination with FOLFIRI to patients randomized to Arm 1.

| 2272736 | ecrin-mdr-crc

Unlimited in vitro expansion of adult bi-potent pancreas progenitors through the Lgr5/Rspondin axis

2013-09-17 | GSE50103 | GEO

Unlimited in vitro expansion of adult bi-potent pancreas progenitors through the Lgr5/Rspondin axis

Project description:Lgr5 marks adult stem cells in multiple adult organs and is a receptor for the Wnt-agonistic R-spondins (RSPOs). Intestinal, stomach and liver Lgr5+ stem cells grow in 3D cultures to form ever-expanding organoids, which resemble the tissues of origin. Wnt signaling is inactive and Lgr5 is not expressed under physiological conditions in the adult pancreas. However, we now report that the Wnt pathway is robustly activated upon injury by Partial Duct Ligation (PDL), concomitant with the appearance of Lgr5 expression in regenerating pancreatic ducts. In vitro, duct fragments from mouse pancreas initiate Lgr5 expression in RSPO1-based cultures, and develop into budding cyst-like structures (organoids) which expand 5-fold weekly for >40 weeks. Single isolated duct cells can also be cultured into pancreatic organoids, containing Lgr5 stem/progenitor cells that can be clonally expanded. Clonal pancreas organoids can be induced to differentiate into duct as well as endocrine cells upon transplantation, thus proving their bi-potentiality We generated arrays from whole pancreas, islet, acinar and duct (Sox9+ sorted) cells and pancreas derived cultures maintained in our defined medium. For the clustering analysis we substracted the pancreas array to all arrays. Genes 2 fold differentially expressed in the ductal array were used for the analsyis. For the genes enriched in organoid cultures compared to pancreas we substracted the organoid culture arrays to the pancreas array. Genes >2-fold differentially expressed were used for the analysis.

2013-09-17 | E-GEOD-50103 | biostudies-arrayexpress

OPAL Study: A Study of Avastin (Bevacizumab) in Combination With FOLFOXIRI in Patients With Previously Untreated Metastatic Colorectal Cancer

Project description:This single arm study will assess progression-free survival, feasibility of use and safety of Avastin in combination with 5-FU/FA, oxaliplatin and irinotecan (FOLFOXIRI) as first line treatment in patients with metastatic colorectal cancer. Patients will receive up to 12 bi-weekly cycles of Avastin (5mg/kg iv) in combination with this standard neoadjuvant chemotherapy regimen followed by up to 40 bi-weekly cycles with Avastin plus 5-FU/FA. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

| 2075225 | ecrin-mdr-crc

A randomized phase II study to investigate the deepness of response of FOLFOXIRI plus cetuximab (Erbitux) versus FOLFOXIRI plus bevacizumab as the first-line therapy in metastatic colorectal cancer patients with RAS wild-type tumors: DEEPER

Project description:Interventions: FOLFOXIRI+Bevacizumab (until 12 courses) 5-FU+Levofolinate+Bevacizumab (after 13 courses) Bevacizumab 5mg/kg/bi-weekly Irinotecan 150mg/m2/bi-weekly Oxaliplatin 85mg/m2/bi-weekly Levofolinate 200mg/m2/bi-weekly 5-FU 2400mg/m2/bi-weekly FOLFOXIRI+Cetuximab (until 12 courses) 5-FU+Levofolinate+etuximab (after 13 courses) Cetuximab (first time) 400 mg/m2/week Cetuximab (after 2nd time) 250 mg/m2/week Irinotecan 150mg/m2/bi-weekly Oxaliplatin 85mg/m2/bi-weekly Levofolinate 200mg/m2/bi-weekly 5-FU 2400mg/m2/bi-weekly Primary outcome(s): DpR: Deepness of Response Study Design: Parallel Randomized

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Phase I study of 5-FU + Oxaliplatin + Irinotecan + Levofolinate + Panitumumab as the first-line therapy in patients with KRAS or RAS wild-type metastatic colorectal cancer

Project description:Interventions: FOLFOXIRI+Panitumumab (Until 12 courses) Panitumumab 6mg/kg/bi-weekly Irinotecan 165-125mg/m2/bi-weekly Oxaliplatin 85mg/m2/bi-weekly Levofolinate 200mg/m2/bi-weekly 5-FU 3200mg/m2/bi-weekly Primary outcome(s): Recommended Dose Study Design: Single arm Non-randomized

| 2630804 | ecrin-mdr-crc

Research on biomarkers in ‘A randomized phase II study to investigate the deepness of response of FOLFOXIRI plus cetuximab (Erbitux) versus FOLFOXIRI plus bevacizumab as the first-line therapy in metastatic colorectal cancer patients with RAS wild-type tumors&quot

Project description:Interventions: FOLFOXIRI+/-Bevacizumab (To 12 courses) 5-FU+Levofolinate+/-Bevacizumab (From 13 courses) Bevacizumab 5mg/kg/bi-weekly Irinotecan 150mg/m2/bi-weekly Oxaliplatin 85mg/m2/bi-weekly Levofolinate 200mg/m2/bi-weekly 5-FU 2400mg/m2/bi-weekly FOLFOXIRI+/-Cetuximab (To 12 courses) 5-FU+Levofolinate+/-Cetuximab (From 13 courses) Cetuximab (first time) 400 mg/m2/week Cetuximab (after 2nd time) 250 mg/m2/week Irinotecan 150mg/m2/bi-weekly Oxaliplatin 85mg/m2/bi-weekly Levofolinate 200mg/m2/bi-weekly 5-FU 2400mg/m2/bi-weekly Primary outcome(s): Correlation between the reported biomarkers or outcome and clinical response. Study Design: Parallel Randomized

| 2633714 | ecrin-mdr-crc

Phase II study of first-line treatment by FOLFOXIRI+bevacizumab in patients with RAS mutant-type metastatic colorectal cancer

Project description:Interventions: FOLFOXIRI +/- bevacizumab (Until 12 course) 5-FU + levoforinate +/- bevacitumab (After 13 course) bevacizumab 5mg/Kg/bi-weekly Irinotecan 150mg/m2/bi-weekly Oxaliplatin 85mg/m2/bi-weekly Levofolinate 200mg/m2/bi-weekly 5-FU 2400mg/m2/bi-weekly Primary outcome(s): Response Rate Study Design: Single arm Non-randomized

| 2630485 | ecrin-mdr-crc

Colorectal cancer classification based on gene expression is not associated with FOLFIRI response

Project description:Sadanandam et al. (2013) recently published a study based on the use of microarray data to classify colorectal cancer (CRC) samples. The classification claimed to have strong clinical implications, as reflected in the paper title: “A colorectal cancer classification system that associates cellular phenotype and responses to therapy”. They defined five subtypes: (i) inflammatory; (ii) goblet-like; (iii) enterocyte; (iv) transit-amplifying; and (v) stem-like. Based on drug sensitivity data from 21 patients, they also reported that the so-called stem-like subtype show differential sensitivity to FOLFIRI. This is the key result in their publication, since it implies a direct relation between the subtype and the choice of CRC therapy (i.e. FOLFIRI response). However, our analyses using the same drug sensitivity data and results from additional patients showed that the CRC classification reported by Sadanandam et al. is not predictive of FOLFIRI response.

2014-09-10 | GSE54483 | GEO

PhaseII study of Combination FOLFIRI with Cetuximab in patients with advanced/metastatic colorectal cancer previously received oxaliplatin-based chemoterapy.

Project description:Interventions: FOLFIRI (CPT-11, 5-FU bolus, 5-FU infusional, l-LV)+ Cetuximab 1) Cetuximab : 500 mg/m2/bi-week 2) CPT-11 : 100 or 150 mg/m2/bi-week 3) l-LV : 200 mg/m2/bi-week 4) 5-FU/bolus : 400 mg/m2/bi-week 5) 5-FU/infusional : 2,400 mg/m2/bi-week (day 1-3) Primary outcome(s): Response rate Study Design: Single arm Non-randomized

| 2622791 | ecrin-mdr-crc

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