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Randomized phase II study of aprepitant in patients with colorectal cancer receiving FOLFOX, FOLFIRI, or XELOX chemotherapy regimen.

ABSTRACT: Interventions: Aprepitant; 125 mg PO on day 1 Aprepitant; 80 mg PO on days 2 to 3 5HT3-receptor antagonist; IV on day 1 Dexamethasone; 6.6 mg IV on day 1 Dexamethasone; 4 mg PO on days 2 to 3 5HT3-receptor antagonist; IV on day 1 Dexamethasone; 9.9 mg IV on day 1 Dexamethasone; 8 mg PO on days 2 to 3 Primary outcome(s): The percentage of patients with complete response (defined as no emetic episode and no rescue therapy) Study Design: Parallel Randomized

DISEASE(S): Colon And Rectal Cancer

PROVIDER: 2622198 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Multicenter Randomized Controlled Trial of Combination Antiemetic Therapy with Aprepitant/Fosaprepitant in Patients with Colorectal Cancer Receiving Oxaliplatin-based chemotherapy

Project description:Interventions: For aprepitant therapy Aprepitant; 125 mg PO on day 1, 80 mg PO on days 2 to 3 5HT3-receptor antagonist; IV administration on day 1 Dexamethasone; 6.6 mg IV on day 1, 4 mg PO on days 2 to 3 For fosaprepitant therapy Fosaprepitant; 150 mg IV on day 1 5HT3-receptor antagonist; IV administration on day 1 Dexamethasone; 6.6 mg IV on day 1, 4 mg PO on day 2 and 8mg PO on day 3 5HT3-receptor antagonist; IV administration on day 1 Dexamethasone; 9.9 mg IV on day 1, 8 mg PO on days 2 to 3 Primary outcome(s): Proportion of patients with ‘No emesis&quot Study Design: Parallel Randomized

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The study of feasibility and usefulness of olanzapine for the patients who received oxaliplatin chemotherapy.

Project description:Interventions: Olanzapine; 5mg PO on days 1 to 4 Aprepitant; 125 mg PO on day 1, 80 mg PO on days 2 to 3 5HT3-receptor antagonist; IV administration on day 1 Dexamethasone; 6.6 mg IV on day 1, 4 mg PO on days 2 to 3 Primary outcome(s): The rate of adverse events Study Design: Single arm Non-randomized

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Study of Aprepitant / Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV) in Colorectal Cancer Patients - SENRI Trial

Project description:The object of this study is to evaluate the superiority of aprepitant therapy with a 5HT3-receptor antagonist, dexamethasone and aprepitant compared to standard therapy with a 5HT3-receptor antagonist and dexamethasone for prevention of nausea and vomiting in first course chemotherapy.

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Aprepitant Without Steroid in Preventing Chemotherapy-induced Nausea and Vomiting in Patients With Colorectal Cancer

Project description:Addition of aprepitant, an NK1 receptor antagonist to a 5-HT3 receptor antagonist and dexamethasone regimen was shown to be effective for prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy (MEC). Little is known about the efficacy of aprepitant when used without dexamethasone. Dexamethasone is widely used to prevent both acute and delayed nausea and vomiting induced by chemotherapy. However, multi-period use of dexamethasone could be associated with side effect, such as hyperglycemia, dyspepsia and insomnia. This randomized phase III trial studies antiemetic therapy with aprepitant and tropisetron to see how well they work compared to dexamethasone plus tropisetron in preventing chemotherapy-induced nausea and vomiting in patients with colorectal cancer receiving FOLFOX(oxaliplatin, leuvovorin and 5-fluorouracil) chemotherapy.

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First-in-Human Study in Healthy Subjects with the Non-Cytotoxic Monoclonal Antibody OSE-127, a Strict Antagonist of the IL-7Rα

Project description:OSE-127 is a humanized monoclonal antibody targeting the IL-7Rα chain (CD127), under development for inflammatory and autoimmune disease treatment. It is a strict antagonist of the IL-7R pathway, is not internalized by target cells and is non-cytotoxic. Here, a first-in-human, phase I, randomized, double-blind, placebo-controlled, single-center study was carried out to determine the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of OSE-127 administration.Sixty-three healthy subjects were randomly assigned to nine groups: six single ascending dose groups with intravenous (IV) administration (0.002-10 mg/kg), a single subcutaneous treatment group (1 mg/kg), and two double IV injection groups (6 or 10 mg/kg). Subjects were followed during < 146 days. OSE-127’s pharmacokinetic half-life after a single dose increased from 4.6 days (1mg/kg) to 11.7 days (10 mg/kg) and, after a second dose, from 12.5 days (6 mg/kg) to 16.25 days (10 mg/kg). Receptor occupancy was ≥ 95% at doses ≥ 0.02 mg/kg and this saturation level was maintained >100 days after two IV infusions at 10 mg/kg. IL-7 consumption was inhibited by OSE-127 administration, as demonstrated by a decreased IL-7 pathway gene signature in peripheral blood cells and by ex-vivo T-lymphocyte restimulation experiments. OSE-127 was well tolerated, with no evidence of cytokine-release syndrome and no significant alteration of blood lymphocyte counts or subset populations.Altogether, the observed lack of significant lymphopenia or serious adverse events, concomitant with the dose-dependent inhibition of IL-7 consumption by target cells highlight that OSE-127 may show clinical activity in IL-7R pathway-involved diseases.

2023-02-01 | GSE224046 | GEO

A Study of Two Different Schedules of Xeloda (Capecitabine) as First Line Therapy in Patients With Metastatic Colorectal Cancer

Project description:This 2-arm study evaluated the efficacy and safety of 2 different treatment schedules of oral Xeloda with intravenous (IV) Eloxatin (oxaliplatin) and IV bevacizumab (Avastin) as a first-line treatment in patients with locally advanced or metastatic colorectal cancer. Patients were randomized to receive either: 1) Xeloda 850 mg/m^2 orally twice a day (po bid) on Days 1-14, oxaliplatin 130 mg/m^2 IV on Day 1, and Avastin 7.5 mg/kg IV on Day 1 of each 3-week cycle; or 2) Xeloda 1500 mg/m^2 po bid on Days 1-7, oxaliplatin 85 mg/m^2 IV on Day 1 and Avastin 5 mg/kg IV on Day 1 of each 2-week cycle. The anticipated time on study treatment was 1-2 years, and the target sample size was 100-500 individuals.

| 2013397 | ecrin-mdr-crc

Examination about the pharmacokinetics of the dexamethasone under the Fosaprepitant medication to the nausea and vomiting of an high emetic risk chemotherapy.

Project description:Interventions: Group A: * 1st course: Palonosetron 0.75mg i.v. on 1st day+Aprepitant 150mg i.v. on 1st day+Dexamethasone 9.9mg i.v. on 1st day, 6.6mg i.v. on 2nd day and 3rd day. * 2nd course: Palonosetron 0.75mg i.v. on 1st day+Aprepitant 150mg i.v. on 1st day+Dexamethasone 9.9mg i.v. on 1st day, 6.6mg i.v. on 2nd day and 13.2mg i.v. on 3rd day. Group B: * 1st course: Palonosetron 0.75mg i.v. on 1st day+Aprepitant 150mg i.v. on 1st day+Dexamethasone 9.9mg i.v. on 1st day, 6.6mg i.v. on 2nd day and 13.2mg i.v. on 3rd day. * 2nd course: Palonosetron 0.75mg i.v. on 1st day+Aprepitant 150mg i.v. on 1st day+Dexamethasone 9.9mg i.v. on 1st day, 6.6mg i.v. on 2nd day and 3rd day. Primary outcome(s): * Blood concentration of dexamethasone Study Design: Cross-over Randomized

| 2629132 | ecrin-mdr-crc

Identification of Rat foreskin biomarkers of in utero dibutyl phthalate exposure [Illumina]

Project description:Dibutyl phthalate was administered to pregnant Sprague Dawley rats from gestational days 16-20 at either a 100 mg/kg/day or 500 mg/kg/day dose level. This timeframe covers the reproductive masculinization window which corresponds to increased androgen signalling. Dibutyl phthalate has been shown to disrupt testosterone production leading to male reproductive abnormalities. As such, we selected this exposure window for our study and examined gene expression changes in the male rat foreskin, which expresses the androgen receptor. We collected tissue samples at both gestational day 20 to identify gene expression changes immediately after exposure, and postnatal day 5 to identify gene expression changes persisting after birth using microarray analysis (Illumina RatRef 12 Bead Chips). To determine whether gene expression changes were brought on by decreased androgen signalling or additional effects of dibutyl phthalate exposure, we exposed rats to the potent androgen receptor antagonist flutamide (5 mg/kg/day) during the same period of development. Gene expression changes were compared to determine which were brought on by disruption of androgen signalling and which were the result of other aspects of chemical exposure.

2013-07-12 | GSE48802 | GEO

Identification of Rat foreskin biomarkers of in utero dibutyl phthalate exposure [Affymetrix]

2013-06-04 | GSE47618 | GEO

Effects of plasticizers on adult human adipocytes (SGBS) using global proteomics

Project description:SGBS cells were used as a model system to investigate the cellular mode of action of a variety of plasticizers in human adipocytes. In brief, cells were cultured at 5% CO2 and 37°C in 95% humidity. Cells of generation 40 and passage 3 after thawing were grown to confluence with DMEM/F12 containing 33 µM biotin, 17 µM pantothenate, 100 U/l penicillin, and 0.1 mg/l streptomycin (basal medium) supplemented with 10% FCS (Gibco, Carlsbad, CA, USA). According to the standard differentiation protocol, differentiation was initiated (day 0) after changing to serum-free basal medium supplemented with 0.1 μM cortisol, 0.01 mg/ml apo-transferrin, 0.2 nM triiodothyronine, and 20 nM human insulin (differentiation medium) with the addition of 2 µM rosiglitazone, 25 nM dexamethasone, and 200 µM 3-isobutyl-1-methylxanthine for the first four days. SGBS cells were first differentiated according to the standard protocol for 12 days. Obtained adult adipocytes were then exposed to the plasticizers for 8 days with medium changes every second day. The control contained equivalent amounts of solvent (0.01% MeOH). Additinally, a control on day 12 before exposure was sampled. All SGBS cell culture experiments were conducted in quadruplets.

2022-06-20 | PXD030843 | Pride

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