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A clinical trial to study the effects of two drugs, R-TPR-023 and Avastinâ?¢ in patients with Metastatic colorectal cancer

ABSTRACT: Intervention1: R-TPR-023: Dose: 5 mg/kg, Frequency: Every 2 weeks, Route of Administration: Intravenously, Duration: 3 years. Control Intervention1: Avastinâ?¢: Dose: 5 mg/kg, Frequency: Every 2 weeks, Route of Administration: Intravenously, Duration: 3 years Primary outcome(s): Outcome Name: Efficacy will be assessed as Objective Response Rate (Complete Response and Partial Response) by RECIST 1.1 criteria at 25 weeksTimepoint: 25 weeks Study Design: Randomized, Parallel Group, Active Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label

DISEASE(S): Patients With Metastatic Colorectal Cancer

PROVIDER: 2574628 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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A clinical trial to study the effects of two drugs, Folfox and CT-011 in patients with cancer of large intestine.

Project description:Intervention1: CT-011: CT-011 (Monoclonal Antibody), 3.0 mg/kg for days 0, 4, 8, 12, 24, 36, 48, 60, 76 along with the combination of FOLFOX . Dose Value; 3mg/kg (OD). Frequency: Every 2 weeks Route: Intravenous TOTAL duration of therapy: 32 months Control Intervention1: Chemotherapy regimens include FOLFOX4 or mFOLFOX6 (5-FU, oxaliplatin: Humanized monoclonal antibody. Treatment details similar as of Intervention. Primary outcome(s): The primary endpoint will be the median progression free survival in patients treated with CT-011 plus FOLFOX compared to that of patients treated with FOLFOX alone. [ Time Frame: 32 months ]Timepoint: Within 32months following the first CT-011 treatment Study Design: Randomized, Parallel Group, Active Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label

| 2575782 | ecrin-mdr-crc

Biomarker analysis of neoadjuvant Doxorubicin/Cyclophosphamide followed by Ixabepilone or Paclitaxel in early-stage breast cancer

Project description:A randomized, open-label, multicenter, phase II trial (NCT00455533) enrolled previously untreated women with histologically-confirmed primary invasive breast adenocarcinoma (T2–3, N0–3, M0, tumor size ≥2.0 cm), regardless of hormone receptor or HER2 expression status. Patients received sequential neoadjuvant therapy starting with 4 cycles of AC (doxorubicin 60 mg/m2 intravenously and cyclophosphamide 600 mg/m2 intravenously) given every 3 weeks, followed by 1:1 randomization to either ixabepilone (40 mg/m2 3-hour infusion) every 3 weeks for 4 cycles, or paclitaxel (80 mg/m2 1-hour infusion) weekly for 12 weeks. Fresh tumor biopsies at screening were a mandatory prerequisite for study entry for biomarker analyses. Gene expression profiling was performed by Affymetrix GeneChip to determine if pre-specified gene models could distinguish between the clinical activity of two microtubule stabilizing agents, ixabepilone and paclitaxel. Three core needle tumor tissue biopsies were obtained from all subjects before neoadjuvant therapy with AC and immediately combined in RNAlater® solution for subsequent RNA extraction, cRNA labeling and gene expression profiling. Pre-specified gene models were tested for their capacity to distinguish pathologic complete response rates between the AC followed by ixabepilone versus the AC followed by paclitaxel treatment regimens. All samples were collected prior to treatment. All subject received cyclophosphamide/doxorubicin (AC) prior to randomization to either Ixabepilone or Paclitaxel.

2013-01-01 | E-GEOD-41998 | biostudies-arrayexpress

Biomarker analysis of neoadjuvant Doxorubicin/Cyclophosphamide followed by Ixabepilone or Paclitaxel in early-stage breast cancer

2013-01-01 | GSE41998 | GEO

A clinical trial to study the safety and efficacy of biosimilar Bevacizumab in patients with metastatic colorectal cancer.

Project description:Intervention1: Biosimilar Bevacizumab: Dosage Form: It will be supplied in concentration of 25 mg/ml single dose vial for injection Dose: 7.5 mg/kg intravenously every 3 weeks for a total of 4 cycles. The initial dose (Cycle 1) should be delivered over 90 minutes as an intravenous infusion. If the first infusion (Cycle 1) is well tolerated, the second infusion (Cycle 2) may be administered over 60 minutes. If the 60-minute infusion is well tolerated, all subsequent infusions may be administered over 30 minutes. Control Intervention1: Innovator Bevacizumab: Dosage Form: It will be supplied in concentration of 25 mg/ml single dose vial for injection Dose: 7.5 mg/kg intravenously every 3 weeks for a total of 4 cycles. The initial dose (Cycle 1) should be delivered over 90 minutes as an intravenous infusion. If the first infusion (Cycle 1) is well tolerated, the second infusion (Cycle 2) may be administered over 60 minutes. If the 60-minute infusion is well tolerated, all subsequent infusions may be administered over 30 minutes. Primary outcome(s): To compare the efficacy of Biosimilar Bevacizumab versus Innovator Bevacizumab, both in Combination with CAPEOX in patients with metastatic colorectal cancer (mCRC) by assessment of best Overall Response Rate (ORR)Timepoint: All patients completed 12 week of treatment. Study Design: Randomized, Parallel Group, Active Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

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A Clinical trial to evaluate the pharmacokinetics, safety, efficacy and immunogenicity of Bmab-100 and Avastin in patients with metastatic colorectal cancer

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Imatinib Mesylate Oral Solution 400mg/5ml with GleevecÂ (Imatinib mesylate) Tablets 400mg in adult human subjects with Chronic Myeloid Leukemia or Gastrointestinal Stromal Tumors under fed condition.

Project description:Intervention1: Imatinib Mesylate Oral Solution 400mg/5ml: Dose: 5 ml(400mg), Frequency: once Daily, Route of Administration: Oral, Duration: 16 Days Control Intervention1: GleevecÂ (Imatinib mesylate) Tablets 400mg: Dose: Single Dose(1 tablet x 400 mg), Frequency: once Daily, Route of Administration: Oral, Duration: 16 Days Primary outcome(s): To compare and evaluate the multiple dose oral bioavailability of Imatinib Mesylate Oral Solution 400mg/5ml of Shilpa Medicare Limited with GleevecÂ (Imatinib mesylate) Tablets 400mg of Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, in adult human patients with Chronic Myeloid Leukemia or Gastrointestinal Stromal Tumors under fed condition.Timepoint: Day:1-Pre-dose blood sample within 1.00 hour prior to dosing, Day:6 and 14- Pre-dose blood sample (-48.0) and Day:7 and 15- Pre-dose blood sample (-24.0) within 1.00 hour prior to dosing, Day:8and16- Pre-dose blood sample (0.0) within 1 hour prior to dosing for 0.5 hours, 1.0 hrs., 1.5 hrs., 2.0 hrs., 2.5 hrs., 3.0 hrs., 3.5 hrs., 4.0 hrs., 5.0 hrs., 6.0 hrs., 8.0 hrs., 10.0 hrs., 12.0 hrs., 16.0 hrs. within Â± 02 minutes, Day:09and17 24 hrs. within Â± 02 minutes Study Design: Randomized, Crossover Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Open Label

| 2594937 | ecrin-mdr-crc

A clinical study to demonstrate bioequivalence between two drugs Xeloda (Reference) and Capecitabine 500 mg Tablets (Test) in cancer patients

Project description:Intervention1: Capecitabine Tablets : Dose & Frequency: 500 mg per day Duration: 3 days (D1, D3, D5) Mode of Administration: Oral Control Intervention1: Capecitabine (Xeloda) Tablets: Dose & Frequency: 500 mg per day Duration: 3 days (D1, D3, D5) Mode of Administration: Oral Primary outcome(s): Establish the bioequivalence of Test vs Reference in relation to the rate and extent of absorption on the basis of the following pharmacokinetic parameters: â?¢Cmax â?¢AUC0tTimepoint: â?¢D1, D3, D5 â?¢D1, D3, D5 Study Design: Other Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label

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MicroRNA155 mediates adverse inflammation in acute viral myocarditis LNA-antimiR155 treatment

Project description:For microRNA knockdown in vivo, a 15-mer LNA-antimiR oligonucleotide targeting mmu-miR-155 or an LNA control was administered to male 4-week-old C3H mice intravenously at a dose of 25 mg/kg per injection at days 1, 4 and 6 post-CVB3 infection. Samples were taken at 6 days post infection.

2012-06-06 | E-MEXP-3395 | biostudies-arrayexpress

4-year survival and biomarkers evaluation from a phase II study of sequential immunotherapy and targeted therapy for metastatic BRAF V600-mutated melanoma

Project description:SECOMBIT is a randomized, three-arm, noncomparative phase II trial (ClinicalTrials.gov identifier: NCT02631447). Patients with untreated, metastatic BRAFV600-mutant melanoma from 37 sites in nine countries were randomly assigned to arm A (encorafenib [450 mg orally once daily] plus binimetinib [45 mg orally twice daily] until progressive disease [PD] -> ipilimumab plus nivolumab [ipilimumab 3 mg/kg once every 3 weeks and nivolumab 1 mg/kg once every 3 weeks ? four cycles -> nivolumab 3 mg/kg every 2 weeks]), arm B [ipilimumab plus nivolumab until PD -> encorafenib plus binimetinib], or arm C (encorafenib plus binimetinib for 8 weeks -> ipilimumab plus nivolumab until PD -> encorafenib plus binimetinib). The primary end point was overall survival (OS) at 2 years. Secondary end points included total progression-free survival, 3-year OS, best overall response rate, duration of response, and biomarkers in the intent-to-treat population.

2023-12-12 | PRJEB70957 | EVA

Intravenous Nanoparticle Vaccination Generates Stem-Like TCF1+ Neoantigen-Specific CD8 T Cells

Project description:Purpose: Single cell RNA sequencing technologies have dramatically increased the resolution at which cells can be characterized. The goal of this study was to characterize the expression differences between neoantigen (neoAg) specific CD8 T cells elicited by a TLR7/8 agonist nanoparticle vaccine delivered intravenously (IV) or subcutaneously (SC). Previous flow cytometry experiments had suggested that IV vaccination resulted in more TCF1+ cells as compared to the SC route. Methods: Mice (n=5) were vaccinated twice, with a 2 week interval between vaccinations. Two weeks after the boost, mice were sacrificed and spleens collected, dissociated and stained with hashtag antibodies/flow cytometry antibodies. NeoAg-specific cells were labelled with a tetramer and sorted on a FACS Aria. Cells were processed through the 10X pipeline. Results: We identified 12 clusters within our antigen specific CD8 T cells. The IV route elicited neoAg+ CD8 T cells with a predominantly stem-like gene signature whereas the SC route elicited more effector genes.

2020-11-02 | GSE158240 | GEO

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