Clinical trials: Digestive Tract Diseases
Solid Tumor
Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations
This was an open-label, Phase 1/2, dose escalation and signal finding study of derazantinib administered to patients with advanced solid tumors (Part 1; Dose Escalation/Food-effect Cohorts) or with advanced solid tumors with FGFR…
- Trial name
- NCT01752920
- Testing
- Derazantinib low dose range, Derazantinib middle dose range, Derazantinib high dose range
- Where
- 12 sites in United States, Italy
- Volunteers
- 119 people
- Sponsor
- Basilea Pharmaceutica
Advanced Solid Tumor, Lung Cancer
A Study of T3011 Administered Via Intravenously in Patients With Advanced Solid Tumors.
This is a multicenter, open-label study conducted in 3 phases: Dose escalation stage: The stage contain 4 cohorts, each cohort divided into 2 groups （group A, single dose and Group B, multiple dose）.Dose escalation will use a 3+3…
- Conditions
- Advanced Solid Tumor, Lung Cancer, Liver Cancer, Lymphoma
- Trial name
- NCT05598268
- Testing
- T3011
- Where
- 7 sites in China
- Volunteers
- 74 people
- Sponsor
- ImmVira Pharma Co. Ltd
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Assessment of a PERT-free Nutritional Therapeutic Delivery System for Cystic Fibrosis
This is a single center, randomized, double-blind, cross-over trial (with a follow-on single-blind safety evaluation stage), assessing a ready-to-drink nutritional supplement used without PERT ("PERT-free"), nutritional…
- Trial name
- NCT04966897
- Testing
- Standard Nutritional Supplement + PERT
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- GlycosBio, Inc.
Cystic Fibrosis
Tobramycin Inhalation Solution Administered by eFlow Rapid Nebulizer: Scintigraphy Study
This study assesses the aerosol delivery characteristics (measured by in vivo lung deposition, nebulization time, serum tobramycin concentrations, and pharmacokinetic parameters) and safety of tobramycin inhalation solution…
- Trial name
- NCT00399945
- Testing
- Tobramycin
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Novartis
Cancer
Phase 2 Safety, Tolerability and Efficacy Study of CPI-613 in Cancer Patients
This Phase II study is conducted to assess the safety and efficacy of CPI-613 in patients with advanced and/or metastatic solid tumors for whom there there is no available therapy to provide clinical benefit or for those who have…
- Trial name
- NCT01832857
- Testing
- CPI-613
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Cornerstone Pharmaceuticals
Breast Cancer, Lung Cancer
IDO Inhibitor Study for Relapsed or Refractory Solid Tumors
This study provides an early evaluation of an entirely new class of small molecule agents directed at disruption or elimination of tumor tolerance, a phenomenon now demonstrated to be involved in the growth of many solid tumors.
- Conditions
- Breast Cancer, Lung Cancer, Melanoma, Pancreatic Cancer
- Trial name
- D-1MT (NCT00739609)
- Testing
- 1-methyl-D-tryptophan
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- NewLink Genetics Corporation
Lung Cancer, Pancreatic Cancer
Safety of AMG 706 Plus Panitumumab Plus Gemcitabine-Cisplatin in the Treatment of Patients With Advanced Cancer
The purpose of this study is to characterize the safety and tolerability of AMG 706 plus panitumumab when administered with gemcitabine and cisplatin chemotherapy. This is a Phase 1b clinical study.
- Conditions
- Lung Cancer, Pancreatic Cancer, Esophageal Cancer
- Trial name
- NCT00101907
- Testing
- AMG 706, Panitumumab, Gemcitabine
- Volunteers
- 41 people
- Sponsor
- Amgen
Acute Graft-Versus-Host Disease, GIGVHD
A Phase 2A Study of ALXN1007 in Participants With Newly Diagnosed Acute Lower Gastrointestinal Graft-Versus-Host Disease
The objectives of this trial were to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD) and efficacy of intravenous (IV) ALXN1007 in participants with acute graft-versus-host disease (GVHD) of the lower…
- Trial name
- GIGVHD (NCT02245412)
- Testing
- ALXN1007 10 mg/kg once weekly, ALXN1007 20 mg/kg once weekly, ALXN1007 20 mg/kg twice weekly
- Where
- 12 sites in United States, France
- Volunteers
- 25 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Cystic Fibrosis
MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to…
- Trial name
- NCT01180634
- Testing
- Aeroquin
- Where
- 112 sites in United States, Australia and 3 more
- Volunteers
- 330 people
- Sponsor
- Amgen
Neoplasms, Melanoma
Study of ASN003 in Subjects With Advanced Solid Tumors
The study is divided into two parts. The first part of the study will test various doses of ASN003 to find out the highest safe dose to test in three specific groups.
- Conditions
- Neoplasms, Melanoma, Colorectal Neoplasm, Carcinoma, Non-small Cell Lung
- Trial name
- NCT02961283
- Testing
- ASN003 ascending doses, ASN003 MTD
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- Asana BioSciences
Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer
A Study Evaluating Safety and Pharmacokinetics of ABBV-221 in Subjects With Advanced Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor
This is an open-label, Phase I, dose escalation study to determine the recommended Phase 2 dose, maximum tolerated dose, and evaluate the safety and pharmacokinetic profile of ABBV-221 in participants with advanced solid tumors…
- Conditions
- Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer, Triple Negative Breast Cancer, Colorectal Carcinoma
- Trial name
- NCT02365662
- Testing
- ABBV-221
- Where
- 5 sites in United States, Spain
- Volunteers
- 46 people
- Sponsor
- AbbVie
Exocrine Pancreatic Insufficiency, Cystic Fibrosis
Control of Steatorrhea in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
This study by Aptalis (formerly Axcan) assesses the efficacy and safety of Panzytrat® 25,000 compared to Kreon® 25,000 in the control of steatorrhea in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency…
- Trial name
- NCT01327703
- Testing
- Panzytrat® 25,000, Kreon® 25,000
- Where
- 13 sites in Germany, Poland
- Volunteers
- 87 people
- Sponsor
- Forest Laboratories
Cystic Fibrosis
A Study Evaluating the Long-Term Safety of Elexacaftor Combination Therapy
This study evaluate the long-term safety and tolerability of elexacaftor (ELX)/tezacaftor (TEZ)/ ivacaftor (IVA) triple combination (TC) in participants with cystic fibrosis (CF) who are homozygous for F508del.
- Trial name
- NCT04362761
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 29 sites in Australia, Belgium and 2 more
- Volunteers
- 172 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
Efficacy and Safety of 28 or 56 Day Treatment for Pseudomonas Aeruginosa in Children With Cystic Fibrosis
This study assessed time to recurrence of infection with Pseudomonas aeruginosa following treatment of the initial infection with tobramycin nebuliser solution.
- Trial name
- ELITE (NCT00391976)
- Testing
- Tobramycin solution for inhalation 300 mg
- Volunteers
- 123 people
- Sponsor
- Novartis
Primary Biliary Cholangitis
Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC
Study to determine the effect of the investigational drug bezafibrate (BZF) alone and in combination with the investigational drug obeticholic acid (OCA) in participants with Primary Biliary Cholangitis (PBC).
- Trial name
- NCT05239468
- Testing
- Bezafibrate 100 mg, Bezafibrate 200 mg, Obeticholic Acid 5 mg
- Where
- 26 sites in United States, Argentina and 2 more
- Volunteers
- 72 people
- Sponsor
- Intercept Pharmaceuticals
Hepatitis C, Chronic, Healthy Volunteer
A Study on Safety, Tolerability and Pharmacokinetics of RO5303253 in Healthy Volunteers and Patients With Chronic Hepatitis C Genotype 1
This randomized, double-blind, placebo controlled, 3 part study will assess the safety, tolerability and pharmacokinetics of RO5303253 in healthy volunteers and patients with chronic hepatitis C genotype 1.
- Trial name
- NCT01181024
- Testing
- RO5303253
- Where
- New Zealand
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Cystic Fibrosis
Study of GLPG1837 in Subjects With Cystic Fibrosis (G551D Mutation)
32 cystic fibrosis patients with the G551D mutation will be treated for 4 weeks, consisting of three consecutive treatment periods: two 1-week periods followed by one 2-week period, evaluating one dose of GLPG1837 each.
- Trial name
- SAPHIRA1 (NCT02707562)
- Testing
- GLPG1837 dose 1, GLPG1837 dose 2, GLPG1837 dose 3
- Where
- 16 sites in Australia, Czechia and 3 more
- Volunteers
- 26 people
- Sponsor
- Lakefront Biotherapeutics NV
Uterine Neoplasms, Uterine Cervical Neoplasms
Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations
This trial studies how well tucatinib works for solid tumors that make either more HER2 or a different type of HER2 than usual (HER2 alterations) The solid tumors studied in this trial have either spread to other parts of the…
- Conditions
- Uterine Neoplasms, Uterine Cervical Neoplasms, Biliary Tract Neoplasms, Urologic Neoplasms
- Trial name
- NCT04579380
- Testing
- tucatinib, trastuzumab, fulvestrant
- Where
- 108 sites in United States, Belgium and 6 more
- Volunteers
- 217 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Breast Cancer, Colon Cancer
EXoPERT EMERALD Clinical Study
The purpose of this study is to establish a multi-center clinical repository of blood samples to support the development and evaluation of an artificial intelligence-based in vitro diagnostic software.
- Conditions
- Breast Cancer, Colon Cancer, Pancreatic Cancer, Ovarian Cancer
- Trial name
- NCT07186296
- Testing
- EXoPred
- Where
- 9 sites in United States
- Volunteers
- 1,400 people, healthy volunteers welcome
- Sponsor
- EXoPERT
Cholelithiasis
Renalof in the Treatment of Elderly Patients With Gallstones
The purpose of this study is to assess the efficacy and safety of Renalof administration in the treatment of gallstones (cholelithiasis) as determined by ultrasonography and clinical evaluation in elderly patients (aged >65…
- Trial name
- NCT01099319
- Testing
- Renalof
- Where
- Cuba
- Volunteers
- 40 people
- Sponsor
- Catalysis SL
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