Clinical trials: Phase I
Pancreatic Adenocarcinoma, Recurrent Pancreatic Carcinoma
Hypofractionated Stereotactic Body Radiation & Fluorouracil or Capecitabine for Locally Advanced Pancreatic Cancer
Pancreatic cancer, most commonly adenocarcinoma, is the fourth leading cause of cancer death in the United States. The mainstay of management centers on surgical resection (if resectable) and although low (15% to 20%)…
- Conditions
- Pancreatic Adenocarcinoma, Recurrent Pancreatic Carcinoma, Stage I Pancreatic Cancer AJCC v6 and v7, Stage IA Pancreatic Cancer AJCC v6 and v7
- Trial name
- NCT03073785
- Testing
- Capecitabine, Fluorouracil, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- University of Nebraska
Advanced Solid Tumors
An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800)
This is a trial to investigate the pharmacokinetics (PK) and the safety of talazoparib in patients with advanced solid tumors and impaired hepatic function.
- Trial name
- NCT02997176
- Testing
- Talazoparib
- Where
- 11 sites in United States
- Volunteers
- 38 people
- Sponsor
- Pfizer
Duchenne Muscular Dystrophy
Safety and Efficacy Study of Antisense Oligonucleotides in Duchenne Muscular Dystrophy
Duchenne muscular dystrophy (DMD), a fatal muscle degenerative disorder, arises from mutations in the dystrophin gene. Antisense therapy with the use of antisense oligonucleotides (AON) has the potential to restore effectively…
- Trial name
- NCT00159250
- Testing
- AVI-4658 (PMO)
- Where
- United Kingdom
- Volunteers
- 7 people
- Sponsor
- Imperial College London
Renal Impairment, Healthy Volunteers
A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys
It is hoped that mobocertinib will eventually help people with cancer with severely reduced kidney function. The main aim of this study is to learn about the levels of mobocertinib in the blood and urine of participants with…
- Trial name
- NCT04056455
- Testing
- Mobocertinib
- Where
- 2 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Diabetes Mellitus, Type 2
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BI 10773 in Type II Diabetes Patients With Different Degrees of Renal Impairment
Assessment of the effect of normal and impaired kidney function on the pharmacokinetics, pharmacodynamics and safety of BI 10773
- Trial name
- NCT01907113
- Testing
- BI 10773
- Where
- 2 sites in Germany
- Volunteers
- 40 people
- Sponsor
- Boehringer Ingelheim
Prostate Cancer
Safety Study of Autologous Dendritic Cells Injected Into the Prostate After Cryoablation for Advanced Prostate Cancer
The purpose of this study is to determine if the intra-tumoral injection of a subject's own dendritic cells after cryotherapy of the prostate is a safe and effective treatment for advanced prostate cancer.
- Trial name
- CRITICAL (NCT00753220)
- Testing
- VDC2008, Cyclophosphamide
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Bostwick Laboratories
Neoplasms
A Phase I/II Open Label Extension Study of BIBF 1120 Administered Orally Once or Twice Daily to Establish Safety, Pharmacokinetics and Efficacy in Patients With Advanced Solid Tumours and Clinical Benefit From Previous Therapy With BIBF 1120
The primary objective of this trial is to evaluate the long-term safety of BIBF 1120 in terms of incidence and intensity of Adverse Events and changes in safety laboratory parameters.
- Trial name
- NCT00715403
- Testing
- BIBF 1120
- Where
- 11 sites in France, Germany
- Volunteers
- 41 people
- Sponsor
- Boehringer Ingelheim
Biliary Atresia
Safety Study of Intravenous Immunoglobulin (IVIG) Post-Portoenterostomy in Infants With Biliary Atresia
The Children Liver Disease Research and Education Network (ChiLDREN) is conducting a clinical trial to determine the feasibility, acceptability, tolerability and safety profile of IVIG treatment administered to infants after…
- Trial name
- PRIME (NCT01854827)
- Testing
- Intravenous immunoglobulin (IVIG)
- Where
- 7 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Adenocarcinoma of the Esophagus, Adenocarcinoma of the Gastroesophageal Junction
A Phase I/II Study of Oblimersen Plus Cisplatin and Fluorouracil in Gastric & Esophageal Junction Cancer
Drugs used in chemotherapy such as cisplatin and fluorouracil use different ways to stop tumor cells from dividing so they stop growing or die.
- Conditions
- Adenocarcinoma of the Esophagus, Adenocarcinoma of the Gastroesophageal Junction, Diffuse Adenocarcinoma of the Stomach, Intestinal Adenocarcinoma of the Stomach
- Trial name
- NCT00064259
- Testing
- oblimersen sodium, cisplatin, fluorouracil
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- National Cancer Institute (NCI)
Covid-19 Prevention
A Study of Ad26.COV2.S in Adults (COVID-19)
The purpose of the study is to assess the safety, reactogenicity, and immunogenicity of Ad26.COV2.S at 2 dose levels, administered intramuscularly (IM) as a single-dose or 2-dose schedule, with a single booster vaccination…
- Trial name
- NCT04436276
- Testing
- Ad26.COV2.S
- Where
- 12 sites in United States, Belgium
- Volunteers
- 1,085 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
Healthy
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Dose Subcutaneous Administration of MEDI-528
A Phase I studyto evaluate the safety and tolerability of escalating subcutaneous (SC) doses of MEDI-528 in to healthy adult volunteers.
- Trial name
- NCT00116168
- Testing
- MEDI-528 0.3 mg/kg, MEDI-528 1 mg/kg, MEDI-528 3 mg/kg
- Where
- 2 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Healthy Subjects
Mucinex® ER 600 mg Bi-layer Tablet Versus Guaifenesin Immediate Release (IR) 200 mg q4h
Demonstrate bioequivalence of guaifenesin in Mucinex® extended release (ER) 600 mg tablet in normal healthy volunteers compared to the immediate release guaifenesin 200 mg tablet reference product marketed
- Trial name
- NCT03642262
- Testing
- Mucinex®
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Reckitt Benckiser Inc.
Refractory or Recurrent Solid Tumors, Rhabdomyosarcoma
Study Evaluating the Safety and Efficacy of Eribulin Mesilate in Combination With Irinotecan Hydrochloride in Children With Refractory or Recurrent Solid Tumors
The Phase 1 part of the study is conducted to determine the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D) of eribulin mesilate in combination with irinotecan hydrochloride in pediatric participants with…
- Conditions
- Refractory or Recurrent Solid Tumors, Rhabdomyosarcoma, Non-Rhabdomyosarcoma Soft Tissue Sarcoma, Ewing Sarcoma
- Trial name
- NCT03245450
- Testing
- Eribulin mesilate, Irinotecan hydrochloride
- Where
- 39 sites in France, Germany and 6 more
- Volunteers
- 40 people
- Sponsor
- Eisai Inc.
Ovarian Cancer, Primary Peritoneal Cavity Cancer
Recombinant Measles Virus Vaccine Therapy and Oncolytic Virus Therapy in Treating Patients With Progressive, Recurrent, or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer
RATIONALE: A gene-modified virus may be able to kill tumor cells without damaging normal cells. PURPOSE: This phase I trial is studying the side effects and best dose of an attenuated oncolytic measles virus therapy and oncolytic…
- Trial name
- NCT00408590
- Testing
- carcinoembryonic antigen-expressing measles virus, oncolytic measles virus encoding thyroidal sodium iodide symporter, reverse transcriptase-polymerase chain reaction
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Mayo Clinic
Pediatrics, Solid Tumors
This is a Phase 1 Study of Eribulin Mesylate in Pediatric Participants With Recurrent or Refractory Solid Tumors (Excluding [Central Nervous System] CNS), Including Lymphomas
This is a Phase 1 study of eribulin mesylate in pediatric participants with recurrent or refractory solid tumors (excluding CNS), including lymphomas.
- Trial name
- BOLD 113 (NCT02171260)
- Testing
- Eribulin Mesylate
- Where
- 18 sites in United States
- Volunteers
- 23 people
- Sponsor
- Eisai Inc.
Healthy
Study of PF 04965842 Effect on MATE1/2K Activity in Healthy Participants
This is a Phase 1, randomized, 2 way crossover, open label study of the effect of PF-04965842 on metformin (a probe for MATE1/2K activity) PK in healthy adult participants.
- Trial name
- NCT03796182
- Testing
- Metformin, PF-04965842
- Where
- Belgium
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Metastatic Endometrial Carcinoma, Recurrent Endometrial Adenocarcinoma
VSV-hIFNbeta-NIS With or Without Ruxolitinib Phosphate in Treating Stage IV or Recurrent Endometrial Cancer
This phase I trial studies the side effects and best dose of vesicular stomatitis virus-human interferon beta-sodium iodide symporter (VSV-hIFNbeta-NIS) with or without ruxolitinib phosphate in treating patients with stage IV…
- Conditions
- Metastatic Endometrial Carcinoma, Recurrent Endometrial Adenocarcinoma, Recurrent Endometrial Carcinoma, Recurrent Endometrial Clear Cell Adenocarcinoma
- Trial name
- NCT03120624
- Testing
- Biopsy, Computed Tomography, Fluorine F 18 Tetrafluoroborate
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Mayo Clinic
Myelodysplastic Syndromes, Hodgkin's Lymphoma
Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation
Background: In allogeneic stem cell transplantation (SCT), stem cells are taken from a donor and given to a recipient. Sometimes the recipient's immune system destroys the donors' cells.
- Conditions
- Myelodysplastic Syndromes, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Acute Leukemia
- Trial name
- NCT02356159
- Testing
- Rituximab, Conditioning chemotherapy, TMS
- Where
- 2 sites in United States
- Volunteers
- 34 people
- Sponsor
- National Cancer Institute (NCI)
Influenza, Vaccine
Safety and Immunogenicity of a Live-attenuated Universal Flu Vaccine Followed by an Inactivated Universal Flu Vaccine
The clinical study will evaluate safety and the immune response of a prime- boost regimen with a live attenuated influenza vaccine (LAIV) prime and an inactivated split influenza vaccine (IIV) boost with or without adjuvant.
- Trial name
- NCT03300050
- Testing
- cH8/1N1 LAIV, AS03-adjuvanted cH5/1N1 IIV, cH5/1N1 IIV
- Where
- 2 sites in United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- PATH
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Trial of MEK Inhibitor and PI3K/mTOR Inhibitor in Subjects With Locally Advanced or Metastatic Solid Tumors
This research trial is testing a combination of two experimental drugs, MSC1936369B (Mitogen-activated protein extracellular signal-regulated kinase (MEK) Inhibitor) and SAR245409 (Phosphatidylinositol 3-kinase (Pi3K)/Mammalian…
- Conditions
- Locally Advanced Solid Tumor, Metastatic Solid Tumor, Breast Cancer, Non Small Cell Lung Cancer
- Trial name
- NCT01390818
- Testing
- MSC1936369B (pimasertib), SAR245409 (PI3K and mTOR inhibitor)
- Where
- 8 sites in United States, Italy and 1 more
- Volunteers
- 146 people
- Sponsor
- EMD Serono
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