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A Multicenter, Open-Label, Phase II Study for the Recombinant Human Interleukin-1 Receptor Antagonist for Injection in Combination of FOLFIRI in Patients with Recurrent Metastatic Colorectal Cancer

ABSTRACT: Interventions: Group A in Part A trial:GR007 90 mg is injected for 3 consecutive days starting from Day 2 before each round of FOLFIRI chemotherapy;Group B in Part A trial:GR007 90 mg is injected for 5 consecutive days starting from Day 4 before each round of FOLFIRI chemotherapy;Dose cohort 1 in Part B trial:GR007 dosage selected based on Part A trial is injected before each round of 1.25 times dose FOLFIRI (except for calcium folinate);Dose cohort 2 in Part B trial:GR007 dosage selected based on Part A trial is injected before each round of 1.5 times dose FOLFIRI (except for calcium folinate);expension group in Part B trial:dose cohort completes in the dose escalation trial, 30 more subjects will be added to enter the expansion trial Primary outcome(s): Total incidence of grade =3 AE and SAE (except for hair loss);Incidence of grade =3 CIN and CID;Total incidence of CIN and CID Study Design: Parallel

DISEASE(S): Colorectal Cancer

PROVIDER: 2684595 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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A phase II multicenter, randomized, double-blind, placebo-control clinical study evaluating the safety and efficacy of UA007 of preventing chemotherapy induced diarrhea in patients with colorectal cancer receiving chemotherapy containing FOLFIRI

Project description:Interventions: Part A 1:UA007 D1, 2, 3 + FOLFIRI;Part A 2:PBO D1 + UA007 D2, 3 + FOLFIRI;Part A 3:UA007 once daily for 3 days + FOLFIRI;Part A extension 1:UA007 + FOLFIRI;Part A extension 2:PBO + FOLFIRI;Part B 1:UA007 + FOLFIRI;Part B 2:PBO + FOLFIRI Primary outcome(s): Incidence rate of CID (chemotherapy induced diarrhea) in Cycle 1 to Cycle 3 that grade is >= 3 Study Design: Parallel

| 47645 | ecrin-mdr-crc

Dose Finding Study in Colorectal Cancer Patients Receiving 5-FU-based Chemotherapy to Assess the Efficacy of Elsiglutide in the Prevention of Chemotherapy Induced Diarrhea (CID)

Project description:This is a randomized, stratified, double-blind, double-dummy, parallel group, placebo-controlled, dose finding, multicentre, multinational, phase II study in patient with colorectal cancer receiving 5- Fluorouracil (5-FU)-based chemotherapy (FOLFOX or FOLFIRI). Patients will receive, starting from the day of chemotherapy administration, a single daily dose subcutaneously (s.c.) of elsiglutide 10, 20 or 40 mg or placebo for 4 consecutive days. Each patient will be in the study for 3 consecutive chemotherapy cycles. The treatment period for each patient will be 4 consecutive days at each of the first 2 chemotherapy cycles. The primary objective is to compare the efficacy of 3 s.c. doses of elsiglutide versus (vs.) placebo and vs. each other dose in the prevention of CID in colorectal cancer patients treated with 5-FU based chemotherapy (FOLFOX or FOLFIRI) with no addition of a monoclonal antibody.

| 2185393 | ecrin-mdr-crc

Humoral Immune response of Galleria mellonella to BCG and APP

Project description:The humoral immune response of Galleria mellonella exposed to Mycobacterium bovis BCG (vaccine strain), 1x107 CFU (10 ul inoculum) were injected into the larvae. For low dose BCG challenge, 1x105 CFU (10 ul) were injected. For larval challenge with Actinobacillus pleuropneumoniae (APP), ~1.5x106 CFU (10 ul) were injected. APP were only challenged at this single dose. For larval challenge with Control (0h) were included. APP and low dose (1x105 CFU) BCG were sampled only at 48 h post infection.

2021-09-08 | PXD015250 | Pride

MicroRNA profiling in male rat germ cells after chronic cyclophosphamide treatment

Project description:Although numerous miRNAs have been identified in the testis, their roles in regulating the highly specific events that occur in the different germ cell types throughout spermatogenesis remain largely unknown. Furthermore, whether male germ cell miRNA expression is altered in response to or as a consequence of exposure to a toxic agent is unknown. Here we examine miRNA expression profiles in pachytene spermatocytes and round spermatids obtained from control rats and from rats treated with a chronic low dose of cyclophosphamide, a male germ cell toxicant. We observed that pachytene spermatocytes and round spermatids display vastly different miRNA expression profiles, reflecting their different developmental stages and possibly influencing the cellular response to toxic insult. Chronic low dose cyclophosphamide treatment altered the miRNA profiles in both pachytene spermatocytes and round spermatids. Target prediction analyses revealed that miRNAs altered by cyclophosphamide treatment may be involved in the response to cellular stress and damage. However, many are also involved in processes that are crucial for proper germ cell development. This study suggests that pachytene spermatocytes and round spermatids display distinct miRNA profiles that can be altered by cyclophosphamide treatment. The observed changes may be part of a response and repair mechanism to cyclophosphamide-induced damage or a dysregulation that disrupts normal germ cell development.

2018-09-05 | GSE119473 | GEO

Accessory subunits are integral for assembly and function of human mitochondrial complex I

Project description:For analysis of mRNA expression levels, total RNA was harvested from each cell-line in replicate with Trizol™ (Thermo scientific). Total RNA was purified using Direct-zol™ columns according to the manufacturers specifications (Zymo Research). For cDNA synthesis 1 μg of total RNA was process as the T12VN-PAT assay (Jänicke et al., RNA 2012), except that this was adapted for multiplexing on the Illumina MiSeq instrument. We refer to this assay as mPAT for multiplexed PAT. The approach is based on a nested-PCR that sequentially incorporates the Illumina platform’s flow-cell specific terminal extensions onto 3’ RACE PCR amplicons. First, cDNA was generated using the anchor primer mPAT Reverse, next this primer and a pool of 50 gene-specific primers were used in 5 cycles of amplification. Each gene-specific primer had a universal 5’ extension (see supplementary file primers) for sequential addition of the 5’ (P5) Illumina elements. These amplicons were then purified using NucleoSpin columns (Macherey-Nagel), and entered into second round amplification using the universal Illumina Rd1 sequencing Primer and TruSeq indexed reverse primers from Illumina. Second round amplification was for 14 cycles. Note, that each experimental condition was amplified separately in the first round with identical primers. In the second round, a different indexing primer was used for each experimental condition. All PCR reactions were pooled and run using the MiSeq Reagent Kit v2 with 300 cycles (i.e. 300 bases of sequencing) according to the manufacturers specifications. Data were analysed using established bioinformatics pipelines (Harrison et al., RNA 2015)

2016-09-08 | GSE84913 | GEO

Mouse EE uterine time course

Project description:Immature, ovariectomized C57BL/6 mice were treated with sesame oil (vehicle) or with 0.1 mg/kg 17-alpha-ethynylestradiol (EE) for the length of time indicated. Mice received one dose, except for the 3x24hr samples, which received 3 consecutive daily doses and were sacrificed 24hr after the final dose. Two replicates of each sample are provided. In addition, one time=0 sample is included. Keywords = uterus estrogen time mouse Keywords: time-course

2003-04-09 | GSE280 | GEO

Project description:IKBKB CID

| PRJNA492843 | ENA

Safety and Efficacy of Pembrolizumab (MK-3475) Plus Binimetinib Alone or Pembrolizumab Plus Chemotherapy With or Without Binimetinib in Metastatic Colorectal Cancer (mCRC) Participants (MK-3475-651)

Project description:The purpose of this study is to determine safety and tolerability and to establish a preliminary recommended Phase 2 dose (RP2D) for the following combinations: pembrolizumab plus binimetinib (Cohort A), pembrolizumab plus mFOLFOX7 (oxaliplatin 85 mg/m^2; leucovorin [calcium folinate] 400 mg/m^2; fluorouracil [5-FU] 2400 mg/m^2) (Cohort B), pembrolizumab plus mFOLFOX7 and binimetinib (Cohort C), pembrolizumab plus FOLFIRI (irinotecan 180 mg/m^2; leucovorin [calcium folinate]400 mg/m^2; 5-FU 2400 mg/m^2 over 46-48 hours) (Cohort D), and pembrolizumab plus FOLFIRI and binimetinib (Cohort E).

| 2261352 | ecrin-mdr-crc

Analysis of SCOTS effect on transcript population

Project description:The cDNA obtained before and after each round of SCOTS (first, second and third) from 2 h post-infection were hybridized to analyse the effect of SCOTS round on transcripts population. The number of detected genes increase with the numer of round of SCOTS. Because the cDNA prepared by 3 round of SCOTS gave the best results, three round of SCOTS were used in the preparation of the other samples. Keywords: Evaluation of SCOTS round

2006-01-10 | GSE3095 | GEO

The CRISPR Screen sequencing raw data

Project description:The hBMEC CRISPR/Cas9 library was seeded in eight T225 flasks with 2 × 107 cells each and incubated for 3 days. The hBMECs doubled every 3 days, generating a total of 3.2 × 108 cells, which were divided into four parts, yielding 8 × 107 cells per experimental condition (~1,000× coverage per perturbation in each library). A quarter of the cells were used as the input library and the remaining three quarters for SzM cytotoxicity screens. The cell libraries were treated with purified SzM protein diluted in DMEM (10% FBS) at a final concentration of 50 μg/ml for 48 hr; when ~50% cells were dead, the surviving cells were out grown in fresh DMEM (10% FBS) without SzM protein. These cells were divided into two parts, one part for genomic DNA extraction, and the other for the next round of screening. The same treatment with 50 μg/ml purified SzM protein for 48 hr was used in the 2nd round and the 3rd rounds, using the same protocol outlined above. After the 3rd round, all cells were harvested for genomic DNA extraction.

2023-05-25 | GSE217997 | GEO

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