PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT01980056: Vosaroxin for Intermediate 2 or High-risk MDS After Failure With Hypomethylating Agent-based Therapy
Official title: A Phase 1/2, Open-label, Dose Escalation Clinical Study of the Safety and Clinical Activity of Vosaroxin in Patients With Intermediate 2 or High-risk Myelodysplastic Syndrome (MDS) After Failure of Hypomethylating Agent-based Therapy
Conditions: Myelodysplastic Syndrome
Summary: Study WCMC IST/VOS/MDS evaluates the safety and tolerability of escalating doses of vosaroxin in adult patients with pathologically confirmed Myelodysplastic Syndrome, or MDS, (< 20% blasts in bone marrow, peripheral blood, or both) by World Health Organization (WHO) classification with an intermediate 2 (INT-2) or high-risk score (ie, ≥ 1.5) as assessed by the International Scoring System (IPSS) after failure of hypomethylating agent-based therapy. Based on 3 completed studies and xenograft models, Vosaroxin is hypothesized to be safe and will effective in this patient population.
Interventions:
description: Dose level 1: Vosaroxin 50 mg^m2 IV on Days 1 and 4 of 28 day cycle Dose level 2: Vosaroxin 72 mg^m2 IV on Days 1 and 4 of 28 day cycle Dose level 3: Vosaroxin 50 mg^m2 IV on Days 1, 4, 8 and 11 of 28 day cycle
name: Vosaroxin
other_name: Qinprezo
type: Drug
Study arms:
design_group_description: All patients will receive vosaroxin according to the dose cohort in which they are enrolled.
design_group_title: Vosaroxin: All Patients
design_group_type: Experimental
Sponsor: Weill Medical College of Cornell University
Collaborators: Sunesis Pharmaceuticals, Inc.
Drug name mappings:
name: 伏利拉辛
lang: CN
name: Vosaroxin
lang: EN
Clinical trial NCT01578070: Single-center Study Evaluating the Safety and Efficacy of Viscogel® as Adjuvant in Act-HIB® Vaccine
Official title: A Single-centre Study Evaluating the Safety of ViscoGel® and Its Safety and Efficacy as an Adjuvant in Act-HIB® Vaccine Administered by Intramuscular Injection to Healthy Volunteers in a Single-blind Randomised, Parallel-group Design
Conditions: Healthy
Summary: The purpose of this study is to show that ViscoGel® is safe when administrated alone and as an adjuvant together with Act-HIB® vaccine in healthy volunteers and to evaluate the quantitative and qualitative effect on the immune response.
Interventions:
description: 0.2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
name: 0.2μg Act-HIB®
type: Biological
description: Pre-selected dose of ViscoGel® (from phase A) and Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
name: ViscoGel® and 0.2μg Act-HIB®
type: Biological
description: Pre-selected dose of ViscoGel® (from phase A) and 2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
name: ViscoGel® and 2μg Act-HIB®
type: Biological
description: 2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
name: 2μg Act-HIB®
type: Biological
description: Clinical standard dose of 10μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
name: 10μg Act-HIB®
type: Biological
Study arms:
design_group_title: ViscoGel® and 0.2μg Act-HIB®
design_group_type: Experimental
design_group_title: 0.2μg Act-HIB®
design_group_type: Experimental
design_group_title: ViscoGel® and 2μg Act-HIB®
design_group_type: Experimental
design_group_title: 2μg Act-HIB®
design_group_type: Experimental
design_group_title: 10μg Act-HIB®
design_group_type: Active Comparator
Sponsor: Viscogel AB
Collaborators: Karolinska Institutet
Pharma Consulting Group AB
Drug name mappings:
name: b型流感嗜血杆菌结合疫苗(Sanofi)
lang: CN
name: Haemophilus b conjugate vaccine(Sanofi)
lang: EN
name: 乾燥ヘモフィルス b 型ワクチン（破傷風トキソイド結合体）
lang: JP
Clinical trial NCT02885766: Study to Evaluate Tolerability, Safety, Pharmacokinetics and Preliminary Efficacy of PF-114 for Oral Administration in Adults With Ph+ Chronic Myeloid Leukemia, Which is Resistant to the 2-nd Generation Bcr-Abl Inhibitors or Has T315I Mutation in the BCR-ABL Gene
Official title: A Multicenter, Open Label Cohort Phase 1 Dose Finding Study to Evaluate Tolerability, Safety, Pharmacokinetics and Preliminary Efficacy of PF-114 Mesylate for Oral Administration in Adult Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML), Which is Resistant to the 2-nd Generation Bcr-Abl Inhibitors or Has T315I Mutation in the BCR-ABL Gene
Conditions: Chronic Myeloid Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Summary: A multicenter, open label cohort Phase 1 dose finding study to evaluate tolerability, safety, pharmacokinetics and preliminary efficacy of PF-114 for oral administration in adult patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML), which is resistant to the 2-nd generation Bcr-Abl inhibitors or has T315I mutation in the BCR-ABL gene.
Interventions:
name: PF-114
type: Drug
Study arms:
design_group_description: PF-114 From 50 mg up to the MTD. Dose escalation for each next cohort is conducted by increasing the dose by 20 % (or the closest lower level, which is a multiple of 25 mg) if there are Grade 3 ADRs according to NCI CTC AE v.4 without reaching а MTD. An increase of the dose by 40 % is applied if there were Grade 2 ADRs. In the absence of Grade 2 or 3 ADRs an increase of 100 % is applied.<br/>When the dose reaches 400 mg/day, the following increase in dose can be made after discussing results of safety findings of PF-114 between the Investigators and the Sponsor.<br/>Orally, once daily
design_group_title: PF-114
design_group_type: Experimental
Sponsor: Fusion Pharmaceuticals, Inc.
Collaborators: Data Matrix Solutions, Inc.
OCT Group LLC
Technopark Skolkovo LLC
Drug name mappings:
name: Vamotinib
lang: EN
Clinical trial NCT05241145: Safety and Preliminary Efficacy of IVMED-80 Eye Drops in Keratoconus Patients
Official title: A Randomized, Controlled, Double-Masked Evaluation of the Safety and Preliminary Efficacy of IVMED-80 on Keratoconus Progression
Conditions: Keratoconus
Corneal Ectasia
Summary: We investigated the use of a copper sulfate eye drop (IVMED-80) for the treatment of keratoconus. Preliminary laboratory data shows that the addition of copper sulfate increase crosslinking of the structural proteins of the cornea thereby halting the progressing corneal thinning and bulging seen in keratoconus. We conducted a Phase 1/2a study to evaluate the safety and preliminary efficacy of a 6-week and a 16-week regimen using IVMED-80 and studied its impact on ocular safety and the change/progression in patients' vision and clinical measurements.
Interventions:
description: Good Manufacturing Practices-grade copper (ІІ) sulfate pentahydrate (CuSO4 #5H2O MW 249.69) was dissolved in a vehicle solution comprised of a balanced salt solution (BSS) with osmolality of approximately 500 mOsm/L. Copper sulfate was concentrated to 0.15 mg/mL. The drops were manufactured on prior to the study at a compounding pharmacy in Salt Lake City, Utah.
name: IVMED-80
type: Drug
description: This was identical to the IVMED-80 product, but without the active ingredient, copper sulfate.
name: Placebo
other_name: IVMED-80 Vehicle
type: Other
Study arms:
design_group_description: In Group 1 (IVMED-6Wk), patients instilled IVMED-80 eye drops into their study eye twice a day for 6 weeks and were followed for an additional 20 weeks without treatment (total 26 weeks)
design_group_title: IVMED-6Wk
design_group_type: Experimental
design_group_description: In Group 2 (IVMED-16Wk), patients instilled IVMED-80 eye drops into their study eye twice a day for 16 weeks and were followed for an additional 10 weeks without treatment (total 26 weeks)
design_group_title: IVMED-16Wk
design_group_type: Experimental
design_group_description: In Group 3 (Placebo), patients instilled IVMED-80 vehicle solution eye drops into their study eye twice a day for 16 weeks and were followed for an additional 10 weeks without treatment (total 26 weeks)
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: iVeena Delivery Systems, Inc.
Collaborators: Codet Vision Institute
Drug name mappings:
name: IVMED-80
lang: EN
Clinical trial NCT00004923: Docetaxel and Irinotecan in Treating Patients With Advanced Solid Tumors
Official title: Dose Escalation Trial of Docetaxel Plus Irinotecan in Patients With Advanced Cancer
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of docetaxel and irinotecan in treating patients who have advanced solid tumors.
Interventions:
name: docetaxel
type: Drug
name: irinotecan hydrochloride
type: Drug
Study arms:
Sponsor: Yale University
Collaborators: National Cancer Institute
Drug name mappings:
name: 多西他赛
lang: CN
name: Docetaxel
lang: EN
name: ドセタキセル
lang: JP
name: 盐酸伊立替康
lang: CN
name: Irinotecan Hydrochloride
lang: EN
name: イリノテカン塩酸塩水和物
lang: JP
Clinical trial NCT01678898: Dose-ranging Study of PRX-102 in Adult Fabry Disease Patients
Official title: A Phase 1/2, Open Label, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of PRX-102 Administered by Intravenous Infusion Every 2 Weeks for 12 Months to Adult Fabry Patients
Conditions: Fabry Disease
Summary: This is the first human treatment with PRX-102, an enzyme being developed as a long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (alpha galactosidase deficiency). The safety, tolerability, and exploratory efficacy will be evaluated in this study of increasing doses. Patients will be treated with infusions every two weeks for 12 months.
Interventions:
name: PRX-102
other_name: plant cell expressed recombinant human alpha-galactosidase-A
type: Drug
Study arms:
design_group_description: PRX-102 0.2 mg/kg every 2 weeks
design_group_title: 0.2 mg/kg
design_group_type: Experimental
design_group_description: PRX-102 1 mg/kg every 2 weeks
design_group_title: 1 mg/kg
design_group_type: Experimental
design_group_description: PRX-102 2 mg/kg every 2 weeks
design_group_title: 2 mg/kg
design_group_type: Experimental
Sponsor: Protalix Biotherapeutics, Inc.
Collaborators: CHIESI Farmaceutici SpA
Drug name mappings:
name: Pegunigalsidase alfa
lang: EN
Clinical trial NCT05886205: Induced Pluripotent Stem Cell Derived Exosomes Nasal Drops for the Treatment of Refractory Focal Epilepsy
Official title: Exploratory Clinical Study on Induced Pluripotent Stem Cell Derived Exosomes (GD-iEXo-002) Nasal Drops for the Treatment of Refractory Focal Epilepsy
Conditions: Refractory Focal Epilepsy
Summary: Evaluate the safety, tolerability, and preliminary efficacy of GD-iEXo-002 nasal drops in the treatment of focal refractory epilepsy
Interventions:
description: iPSC-Exos were administrated for nasal drip, bid for 12 weeks.
name: iPSC-Exos
type: Drug
Study arms:
design_group_description: group1-low-dose group, 8 papatients are treated with 2 μg iPSC-Exos in 200 μL. group2-mid-dose group, 8 papatients are treated with 6 μg iPSC-Exos in 200 μL. group3-mid-dose group, 8 papatients are treated with 18 μg iPSC-Exos in 200 μL. group4-Dose expansion, 10 papatients are treated with iPSC-Exos in 200 μL. iPSC-Exos were administrated for nasal drip, bid for 12 weeks.
design_group_title: iPSC-exosome treatment
design_group_type: Experimental
Sponsor: Peking Union Medical College Hospital
Drug name mappings:
name: GD-iEXo-002
lang: EN
Clinical trial NCT04870671: Project ADHERE: Clinical Proof-of-Concept of a Tenofovir (TFV) Aptamer-Based Biosensor
Official title: Project ADHERE: Clinical Proof-of-Concept of a Tenofovir (TFV) Aptamer-Based Biosensor for Determining Adherence Using Different Dosing Regimens of Disoproxil Fumarate/Emtricitabine (TDF/FTC)
Conditions: HIV/AIDS
Adherence, Medication
Drug Use
Summary: Truvada®, an oral pill comprised of two anti-retroviral compounds, emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), is currently the only drug combination approved for pre-exposure prophylaxis (PrEP) in women exposed to high HIV risk through vaginal acquisition. Adherence to the one pill per day regimen is crucial for its effectiveness in reducing the risk of acquiring HIV. Currently, there is no available point of care diagnostic test to quickly measure blood levels of tenofovir in the clinic. This study will determine whether a tenofovir (TFV) aptamer-based biosensor (aptasensor) can detect TFV in biological fluids from women randomized to different dosing regimens representing high and low adherence.
Interventions:
description: Women will take 1 pill orally according the dosing regimen of the arm to which they are assigned
name: Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC)
other_name: Truvada
type: Drug
Study arms:
design_group_description: TDF/FTC (300/200 mg), 7 pills/week. Total of 14 pills
design_group_title: High Adherence
design_group_type: Experimental
design_group_description: TDF/FTC (300/2200 mg), 3 pills/week. Total of 6 pills
design_group_title: Low Adherence
design_group_type: Experimental
Sponsor: Eastern Virginia Medical School
Collaborators: National Institute of Allergy & Infectious Diseases
Drug name mappings:
name: 恩曲他滨替诺福韦
lang: CN
name: Emtricitabine/Tenofovir Disoproxil Fumarate
lang: EN
name: エムトリシタビン/テノホビル ジソプロキシルフマル酸塩
lang: JP
Clinical trial NCT04028245: A Study of Combination Spartalizumab and Canakinumab in Patients With Localized Clear Cell Renal Cell Carcinoma
Official title: A Pilot Study of Neoadjuvant Combination Spartalizumab and Canakinumab Prior to Radical Nephrectomy in Patients With Localized Clear Cell Renal Cell Carcinoma (SPARC-1 Trial)
Conditions: Carcinoma, Renal Cell
Summary: Primary Objective:
* To confirm the safety and feasibility of canakinumab and spartalizumab (PDR-001) administered using a standard dose / schedule in the neo-adjuvant setting in renal cell carcinoma
Secondary Objectives:
* To assess the immune response to combination canakinumab and spartalizumab
* To assess anti-tumor activity as measured by pathologic downstaging
Interventions:
description: Spartalizumab at 400 mg weeks x 2 doses prior to radical nephrectomy Infusion
name: Spartalizumab
other_name: PDR-001
type: Drug
description: Canakinumab 300 mg IV Q4 weeks x 2 doses prior to radical nephrectomy Infusion
name: Canakinumab
other_name: ACZ885
type: Drug
Study arms:
design_group_description: Subjects with renal cell carcinoma will receive study treatment Q4 weeks x 2 doses prior to radical nephrectomy.
design_group_title: Spartalizumab and Canakinumab
design_group_type: Experimental
Sponsor: Columbia University
Collaborators: Novartis AG
Drug name mappings:
name: 卡那奴单抗
lang: CN
name: Canakinumab
lang: EN
name: カナキヌマブ（遺伝子組換え）
lang: JP
name: Spartalizumab
lang: EN
Clinical trial NCT00414570: An Imaging Study of [18]F-fluoro-3'-Deoxy-3'-L-fluorothymidine ([18]F-FLT) in Patients With Locally Advanced or Metastatic Pancreatic Cancer Who Will be Treated With Gemcitabine or Other Nucleoside Analogs
Conditions: Pancreatic Cancer
Summary: The objectives of this pilot study are: (i) to compare response to chemotherapy, time to disease progression and overall survival in patients with pancreatic cancer who will be treated with gemcitabine (or other nucleoside analogs) who demonstrate [18]F-FLT uptake to those patients who do not demonstrate [18]F-FLT uptake; (ii) to correlate [18]F-FLT uptake with hENT1 expression in biopsy samples where available; (iii)to determine the presence or absence of uptake, the relative uptake score (RUS), standardized uptake value (SUV), and tumor to background ratios (T/B) of [18]F-FLT in patients with known carcinoma of the pancreas and assess this uptake in relation to time to disease progression; and (iv) to demonstrate the safety of [18]F-FLT.
Interventions:
description: Injection of [18]F-FLT radiopharmaceutical followed by PET imaging.
name: [18]F-FLT PET scan
other_name: [18]F-FLT Positron Emission Tomography scan
type: Drug
Study arms:
design_group_description: Radioactive dose of 2.59 MBq/kg (range 100 - 350 MBq) [18]F-FLT per injection prior to Positron Emission Tomography (PET) imaging. [18]F-FLT PET scans at baseline/pre-treatment and at disease progression, up to a maximum of two separate [18]F-FLT PET scans per participant.
design_group_title: [18]F-FLT PET scan
design_group_type: Experimental
Sponsor: AHS Cancer Control Alberta
Collaborators: Cross Cancer Institute
Drug name mappings:
name: Fluorothymidine F-18
lang: EN
Clinical trial NCT05798507: Identification of Treatment Concentrations of Defactinib or VS-6766 for the Treatment of Patients With Glioblastoma
Official title: A Single-Dose Study of Orally Administrated Defactinib or VS-6766 in Patients With Glioblastoma
Conditions: Glioblastoma
Recurrent Glioblastoma
Summary: This early phase I trial tests brain concentration level and safety of defactinib or VS-6766 for the treatment of patients with glioblastoma. Recently, two new drugs that seem to work together have been shown to have promising treatment effects in tissue culture and animal models of glioblastoma. Each inhibits a different glioblastoma growth pathway and when used together may create a larger effect on tumor growth than either alone. Growth pathway describes a series of chemical reactions in which a group of molecules in a cell work together to control cell growth. It is known that glioblastoma tumor cells can grow because of lack of regulation. Both Pyk2 and the closely related kinase (FAK) proteins help regulate tumor cell invasion, unless they are produced in large amounts (over expressed). Specifically, Raf and FAK/Pyk2 regulation of cell division is activated quite a bit more in gliomas compared to normal tissues. Recently developed inhibitors of Raf (VS-6766) and FAK (defactinib) which belong to a class of medications called kinase inhibitors, are aimed to bring their activity to proper levels and may stop tumor growth.
Interventions:
description: Given PO
name: Avutometinib
other_name: CH-5126766
CH5126766
CKI-27
R-7304
RG 7304
RG-7304
RG7304
RO5126766
Raf/MEK Inhibitor VS-6766
VS 6766
VS-6766
VS6766
type: Drug
description: Undergo blood and tissue sample collection
name: Biospecimen Collection
other_name: Biological Sample Collection
Biospecimen Collected
Specimen Collection
type: Procedure
description: Given PO
name: Defactinib
type: Drug
Study arms:
design_group_description: Patients receive 1 dose of defactinib PO while on study, prior to planned tumor resection. Patients undergo blood collection and donate resected tumor tissue while on study.
design_group_title: Arm I (Defactinib)
design_group_type: Experimental
design_group_description: Patients receive 1 dose of avutometinib PO while on study, prior to planned tumor resection. Patients undergo blood collection and donate resected tumor tissue while on study.
design_group_title: Arm II (Avutometinib)
design_group_type: Experimental
Sponsor: Emory University
Collaborators: National Cancer Institute
Verastem, Inc.
Drug name mappings:
name: 阿伐替尼/地法替尼
lang: CN
name: Avutometinib/Defactinib
lang: EN
Clinical trial NCT05555550: Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG
Official title: Evaluation of 18F-Fluciclovine PET-MRI as a Biomarker of Response in Pediatric and Young Adult Patients With Low Grade Gliomas (LGG)
Conditions: Glioma
Low-grade Glioma
Low Grade Glioma of Brain
Glioma, Malignant
Glioma Intracranial
Summary: The purpose of this study is to see if 18F-Fluciclovine (Axumin®) is useful and safe in the management of children with Low Grade Gliomas (LGG). Imaging with 18F-Fluciclovine PET-MRI will be performed prior to initiation of therapy for LGG, and then 3 months, and 1 year after starting therapy. Changes in 18F-Fluciclovine uptake will be compared to changes in MRI measurements at 3 months and 1 year as compared to baseline.
Interventions:
description: 18F-Fluciclovine will be injected via IV prior to PET-MRI imaging
name: 18F-Fluciclovine
other_name: Axumin
type: Drug
Study arms:
design_group_description: 18F-Fluciclovine PET-MRI
design_group_title: 18F-Fluciclovine
design_group_type: Experimental
Sponsor: The Children's Hospital of Philadelphia
Collaborators: Blue Earth Diagnostics Ltd.
Drug name mappings:
name: [18F]氟氨基丁酸
lang: CN
name: Fluciclovine 18F
lang: EN
name: フルシクロビン（18F）
lang: JP
Clinical trial NCT01633762: Eradication of Gut Microbiota
Official title: Eradication of Gut Microbiota - Effects on Postprandial Gut Hormone Secretion, Glucose Metabolism, Bone Metabolism and Gut Microbiome
Conditions: Diabetes
Obesity
Osteoporosis
Inflammation
Summary: The aim of the study is to assess the effect of eradication of gut microbiota on 1) glucose metabolism including postprandial plasma responses of the incretin hormones GIP and GLP-1, insulin, C-peptide and glucagon, 2) metabolomic profiles and resting energy expenditure (REE) 3) appetite, satiety, food intake, gastric emptying and gall bladder emptying, 4) levels of markers of bone formation and resorption as well as serotonin, 5) markers of systemic inflammation, and 6) on the (prospective) composition of bacteria in faeces, blood and saliva. Thus, the overall objective is to provide detailed knowledge on the physiological role of gut microbiota combined with bioinformatic analyses of the functional implications of changes in bacteria composition on the level of both species and phylum.
Interventions:
description: 4 days antibiotic treatment, per oral, once daily: vancomycin 500 mg (Vancomycin "Hospira"), powder for concentrate; gentamycin 40 mg ("Hexamycin®"), solution; meropenem 500 mg (Meropenem "Hospira"), powder for concentrate; The three drugs are dissolved and combined to a cocktail (with approximately 100 ml of apple juice)
name: meropenem, gentamicin, vancomycin (together)
type: Drug
Study arms:
design_group_title: meropenem, gentamicin, vancomycin
design_group_type: Experimental
Sponsor: Gentofte Hospital
Collaborators: University of Copenhagen
Rigshospitalet
Steno Diabetes Center A/S
Drug name mappings:
name: 美洛培南
lang: CN
name: Meropenem
lang: EN
name: メロペネム水和物
lang: JP
name: 硫酸庆大霉素
lang: CN
name: Gentamicin Sulfate
lang: EN
name: ゲンタマイシン硫酸塩
lang: JP
name: 盐酸万古霉素
lang: CN
name: Vancomycin Hydrochloride
lang: EN
name: バンコマイシン塩酸塩
lang: JP
Clinical trial NCT01713218: Effect on Tumor Perfusion of a Chemotherapy Combining Gemcitabine and Vismodegib Before Surgery in Pancreatic Cancer
Official title: Evaluation of Tumoral Perfusion Modification by Dynamic Imaging After Neoadjuvant Chemotherapy Combining Gemcitabine and a Hedgehog Inhibitor (Vismodegib) in Patients With Resectable Pancreatic Adenocarcinoma
Conditions: Pancreatic Adenocarcinoma Resectable
Summary: Pancreatic ductal adenocarcinoma (PDAC) has one of the worst prognoses of all human cancers and is considered as a sanctuary, resistant to most of the drugs used. Identification of new molecular targets involved in its pathogenesis is urgently needed and required both proper and innovative efficacy assessment.
This proof-of-concept trial is studying the "dynamic" tumor response after the administration of a short course (4 weeks) neoadjuvant combination of gemcitabine and a Hedgehog inhibitor (Vismodegib) before surgery in patients with operable pancreatic cancer.
Interventions:
description: Administrated intravenously at a dose of 1000 mg/m2 over 30 minutes weekly, week 1 to 4
name: gemcitabine
other_name: GEMZAR
type: Drug
description: 150 mg capsule, oral, once daily
name: Vismodegib
other_name: GDC-0449
type: Drug
description: Combination of gemcitabine and Vismodegib during a window interval (4 weeks) before surgery
name: Neoadjuvant chemotherapy
type: Procedure
Study arms:
design_group_description: Neoadjuvant chemotherapy combining gemcitabine and Vismodegib during 4 weeks before surgery
design_group_title: Gemcitabine+Vismodegib
design_group_type: Experimental
Sponsor: Hôpital Erasme
Collaborators: Roche Pharma AG
Drug name mappings:
name: 盐酸吉西他滨
lang: CN
name: Gemcitabine Hydrochloride
lang: EN
name: ゲムシタビン塩酸塩
lang: JP
name: 维莫地吉
lang: CN
name: Vismodegib
lang: EN