Browse
Submit Data
Databases
API
Help

Dataset Information

13 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

A Phase 2, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safetyand Efficacy of FOLFIRI in Combination With AMG 479 or AMG 655 Versus FOLFIRI for the Second-line Treatment of KRAS-mutant Metastatic Colorectal Carcinoma

ABSTRACT: Primary objectives: The primary objective is to estimate the treatment effect on progression-free survival(PFS) of AMG 655 plus FOLFIRI or AMG 479 plus FOLFIRI relative to FOLFIRI alone when administered as a second-line treatment for subjects with metastatic colorectalcancer (mCRC) whose tumors express mutant-type Kirsten rat sarcoma virus oncogene homolog (KRAS). Primary endpoints: Progression Free Survival (PFS)PFS time is defined as the time from the date of randomization to the first observation of disease progression (as classified by modified RECIST based on the investigator assessment of radiographic scans, or clinical progression whichever occurs first,) or death due to any cause. If a subject’s disease has not progressed and the subject is alive by the analysis data cut-off date, PFS will be censored at the last date they are known to be progression-free (ie, the last evaluable disease assessment date).

DISEASE(S): Metastatic Colorectal Cancer,Second-line Treatment Of Kras Mutant-type Metastatic Colorectal Cancer.

PROVIDER: 2525121 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Json Xml

Similar Datasets

Transcription profiling of rat tissues dosed with AMG A or AMG B

Project description:To evaluate and characterize gene expression changes and toxicity following oral gavage administration of AMG A & AMG B in male Sprague Dawley rats. Experiment Overall Design: This toxicogenomics study is designed to determine the toxicity and gene expression of AMG A and AMG B dosed orally daily (AMG A at 0mg/kg, 3mg/kg and 30 mg/kg and AMG B at 0mg/kg, 3mg/kg and 60mg/kg) for 1, 4 and 14 days. These doses are expected to produce mild and moderate changes in clinical pathology and histology associated with the pharmacologic antiangiogenic effect.

2008-06-11 | E-GEOD-10015 | biostudies-arrayexpress

A Study of RO5083945 in Combination With FOLFIRI Versus FOLFIRI Plus Cetuximab or FOLFIRI Alone as Second Line Treatment in Patients With Metastatic Colorectal Cancer

Project description:Primary objectives: • to gather preliminary evidence of superior activity, of RO5083945 added to FOLFIRI versus FOLFIRI + cetuximab in terms of progression free survival (PFS) in patients with KRAS WT colorectal cancer • to gather preliminary evidence of superior activity, of RO5083945 added to FOLFIRI versus FOLFIRI alone in terms of progression free survival (PFS) in patients with KRAS mutant colorectal cancer Primary endpoints: The primary variable is PFS defined as the time between randomization and date of first documented disease progression or death, whichever occurs first.

| 2528754 | ecrin-mdr-crc

QUILT-2.018: Safety & Efficacy of FOLFIRI With AMG 479 or AMG 655 vs FOLFIRI Alone in KRAS-mutant Metastatic Colorectal Carcinoma

Project description:This is a phase 2, multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-arm trial to be conducted in the United States, Europe, and Asia. Approximately 150 eligible KRAS-mutant metastatic colorectal cancer subjects who have failed first line fluoropyrimidine and oxaliplatin-based regimen with or without anti-VEGF therapy will be randomized in a 1:1:1 ratio to receive AMG 479 placebo plus AMG 655 with FOLFIRI, or AMG 479 plus AMG 655 placebo with FOLFIRI, or AMG 479 placebo plus AMG 655 placebo with FOLFIRI

| 2065658 | ecrin-mdr-crc

Expression data from rat tissues dosed with AMG A or AMG B

Project description:To evaluate and characterize gene expression changes and toxicity following oral gavage administration of AMG A & AMG B in male Sprague Dawley rats. Keywords: dose response

2007-12-23 | GSE10015 | GEO

Ovarian Cancer prognosis: Different methylation in patients with PFS <3 years vs. >3 years

Project description:Identification of differently methylated regions of CpG islands in epithelial ovarian cancer (EOC) tissue from patients with progression free survival <3 years (worse outcome) vs. patients with PFS >3 years (good outcome, relapse free until last follow up). Patients were homogenous in regard to clinical (FIGO III/IV, serous histology, optimally resected (macroscopically tumor free), platin-taxan chemotherapy) and molecular properties (immunohistochemistry for p16, BRCA1, Ki67 and p53)).

2015-11-16 | GSE62851 | GEO

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

Pantoea sp. AMG 501

Project description:Pantoea sp. AMG 501 Genome sequencing and assembly

| PRJNA389525 | ENA

A multicentre randomised phase II study of aflibercept plus chemotherapy in patients with colorectal liver-only metastases deemed to be inoperable or unsuitable for upfront liver resection

Project description:MAIN STUDY: Primary objectives:• Progression free survival (PFS) of FOLFIRI plus cetuximab versus FOLFIRI plus aflibercept in patients with liver metastases deemed to be inoperable or unsuitable for upfront resection and with with RAS wild type (WT) disease.• In patients with RAS mutant CRC, to compare progression free survival of FOLFOXIRI versus FOLFIRI plus aflibercept or FOLFOXIRI plus aflibercept in patients with liver metastases deemed to be inoperable or unsuitable for upfront resection. The primary Endpoint of the study is one year-PFS The genetic material (DNA) in cancer cells can influence whether cancer responds to anti-cancer treatments. One of those characteristics is determined by examining a gene called RAS. RAS is an important downstream protein in the epridermal growth factor receptor (EGFR) pathway. Previous research has shown that testing for RAS can help guide treatment for mCRC. If no mutations are identified in the RAS genes, the tumour is referred Primary endpoints: FOR MAIN STUDY: To measure 1-year progression free survival (PFS) in patients treated on the study. This will be measured from date of randomisation to date of first appearance of disease progression, relapse, death from any cause; patients alive without progression or relapse will be censored at date last known to be alive. FOR SAFETY RUN-IN PHASE: In patients with metastatic colorectal cancer (CRC), to find the maximum tolerated dose (MTD)of FOLFOXIRI plus aflibercept

| 2533044 | ecrin-mdr-crc

MONARCC: A randomised phase II study of Panitumumab monotherapy and panitumumab plus 5 fluorouracil as first line therapy for RAS and BRAF wild type metastatic colorectal cancer.

Project description:Interventions: Intravenous panitumumab 6mg/Kg every 2 weeks until disease progression or unacceptable toxicity. Primary outcome(s): The primary endpoint is the rate of progression free survival at 6 months defined according to RECIST V1.1 criteria[Progression free survival (PFS) is defined as the interval from date of randomisation to the date of first evidence of disease progression or death, whichever occurs first. The time point for PFS is 6 months after the last patient has been enrolled ] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy

| 2466640 | ecrin-mdr-crc

Gene expression profile in relapsed or metastatic HNSCC patients treated with cetuximab and platinum therapy

Project description:First line chemotherapy with platinum and cetuximab is usually offered to RM-HNSCC pts. In the Extreme trial a median progression free survival (PFS) time of 5.6 months was reported. However, a small fraction of pts achieves a prolonged PFS (> than 12 months). Till now, no recognized predictive biological factor has been identified. A group of 14 cases treated with a first line platinum and cetuximab with a PFS exceeding 12 months (long PFS) and a group of 26 pts with a PFS less than 5.6 months (short PFS) were selected. The 2 groups were well balanced in regard to recognized prognostic factors (performance status, weight loss, prior radiotherapy, tumor grade, site of primary tumor, residual disease at primary tumor site). Tumor specimens of the recurrence or, if not available, of the primary tumor were collected. In order to identify molecular profiles deregulated between the 2 groups, a gene expression microarray analysis was performed using the Whole-Genome DASL assay and HumanHT-12_v4 BeadArray chips (lllumina). Gender: male=0; female=1. Age: years at diagnosis Site of primary: oral cavity=0; oropharynx=1; hypopharynx=2; larynx=3. Stage of T at first diagnosis according to AJCC 8th edition Grading according to WHO: well differentiated=1; moderately differentiated=2; scarcely differentiated=3. Radiotherapy (RT) prior to recurrence: No=0; Yes=1. Progression Free Survival (PFS): Long (>12 months); Short(<5 months).

2016-08-01 | E-GEOD-65021 | biostudies-arrayexpress

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