Clinical trials: Phase I
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
Drug-Drug Interaction Study of TAK-788 and Midazolam in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)
The purpose of this study is to characterize the effect of repeated oral administration of TAK-788 160 milligram (mg) once daily on the single oral and intravenous dose pharmacokinetics (PK) of midazolam.
- Trial name
- NCT04051827
- Testing
- Midazolam, TAK-788
- Where
- 8 sites in Australia, Netherlands and 1 more
- Volunteers
- 26 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Advanced Solid Tumors, Metastatic Melanoma
Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors
This is an open-label, 3-arm, fixed-sequence study to evaluate the effect of single and multiple oral doses of encorafenib in combination with binimetinib on the single oral dose pharmacokinetics (PK) of cytochrome P450 (CYP)…
- Trial name
- NCT03864042
- Testing
- losartan, dextromethorphan, caffeine
- Where
- 29 sites in United States, Belgium and 3 more
- Volunteers
- 56 people
- Sponsor
- Pfizer
Leukemia, Myeloid, Acute
Volasertib + Decitabine in Patients With Acute Myeloid Leukemia (AML)
Dose Escalation (MTD Finding) Phase: To investigate the maximum tolerated dose (MTD), safety and pharmacokinetics of different volasertib administration schedules in combination with decitabine in previously untreated AML…
- Trial name
- NCT02003573
- Testing
- decitabine iv, volasertib iv infusion
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- Boehringer Ingelheim
Epidermolysis Bullosa Dystrophica, Epidermolysis Bullosa
Gene Transfer for Recessive Dystrophic Epidermolysis Bullosa
This trial will create a skin graft, which the investigators call "LEAES," using the patient's own skin cells that have been genetically engineered in the lab to express a missing protein called type VII collagen.
- Trial name
- NCT01263379
- Testing
- LZRSE-Col7A1 Engineered Autologous Epidermal Sheets
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Abeona Therapeutics, Inc
DLBCL, Richter Syndrome
A Study of Acalabrutinib and Vistusertib in Subjects With Relapsed/Refractory B-cell Malignancies
This study evaluates the safety of acalabrutinib and vistusertib when taken in combination.
- Trial name
- NCT03205046
- Testing
- acalabrutinib, vistusertib
- Where
- 11 sites in United States, United Kingdom
- Volunteers
- 25 people
- Sponsor
- Acerta Pharma BV
Clostridium Infections
Safety, Tolerability, and Immunogenicity of a Clostridium Difficile Toxoid Vaccine in Healthy Elderly Volunteers
The purpose of this study is to determine the safety and tolerability of a modified C. difficile vaccine at 3 dose levels compared with a placebo control administered via intramuscular injection in healthy elderly subjects aged >…
- Trial name
- NCT00214461
- Testing
- C. difficile toxoid vaccine (2 µg), C. difficile toxoid vaccine (10 µg), C. difficile toxoid vaccine (50 µg)
- Where
- 2 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Sanofi
Bladder Cancer
Radiation Therapy and Chemotherapy in Treating Patients With Stage I Bladder Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal…
- Trial name
- NCT00981656
- Testing
- cisplatin, 5-fluorouracil, Mitomycin
- Where
- 13 sites in United States
- Volunteers
- 37 people
- Sponsor
- Radiation Therapy Oncology Group
Clostridium Difficile Infection, Clostridium Difficile Diarrhea
Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity
This Phase I, randomized, placebo-controlled, double-blinded, dose ranging study to assess the safety, tolerability, and immunogenicity of 2 dose levels of C. difficile vaccine.
- Trial name
- NCT00772954
- Testing
- Vaccine diluent buffer, Clostridium difficile toxoid vaccine (50 μg), Clostridium difficile toxoid vaccine (100 μg)
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Sanofi
Gliosarcoma, Newly Diagnosed
Selinexor (KPT-330) in Combination With Temozolomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma
Background: Glioblastoma is a type of brain cancer. Treatments include radiation, chemotherapy, and surgery. But survival rates are poor.
- Conditions
- Gliosarcoma, Newly Diagnosed, Glioblastoma
- Trial name
- NCT04216329
- Testing
- Selinexor, Temozolomide, Generic Radiation therapy (RT)
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- National Cancer Institute (NCI)
Rectal Cancer, Colo-rectal Cancer
A Phase 1-2 Trial of Cetuximab in Combination With Oxaliplatin, Capecitabine, and Radiation Therapy Followed by Surgery for Locally-advanced Rectal Cancer
The objectives of this study are to: 1. To assess dose-limiting toxicities (DLTs) of capecitabine +/- oxaliplatin in a combination regimen with capecitabine and radiotherapy (Phase 1) 2.
- Trial name
- NCT00226941
- Testing
- Cetuximab, Oxaliplatin, Capecitabine
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- George Albert Fisher
Solid Tumors
A Study of Safety, Tolerability and Pharmacokinetics of Nivolumab in Chinese Subjects With Previously Treated Advanced or Recurrent Solid Tumors
The purpose of this study is to determine whether nivolumab is safe and effective in the treatment of advanced or recurrent solid tumors in Chinese subjects.
- Trial name
- CheckMate 077 (NCT02593786)
- Testing
- Nivolumab
- Where
- 2 sites in China
- Volunteers
- 58 people
- Sponsor
- Bristol-Myers Squibb
HIV Infections
Study to Evaluate Pharmacokinetic (PK), Safety and Tolerability of Cabotegravir (CAB) 400 Milligrams Per Milliliter (mg/mL) Formulation in Healthy Adult Participants
This is an active control, randomized study to investigate the safety, tolerability and PK of repeat dose administration of long-acting CAB 400 mg/mL formulation intramuscular (IM) (gluteus medius and vastus lateralis) and…
- Trial name
- NCT04484337
- Testing
- Cabotegravir sodium (Oral Lead In), Cabotegravir 400 mg/mL, Cabotegravir 200 mg/mL
- Where
- 5 sites in United States, New Zealand
- Volunteers
- 138 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Dental Caries
Efficacy Of A PVP-I Fluoride Varnish
The purpose of the study is to determine the efficacy of Advantage Anti-Caries Varnish. Single-center, double-blind, controlled Phase 2 study with parallel groups of children.
- Trial name
- NCT03082196
- Testing
- Test varnish, Standard varnish
- Where
- Micronesia
- Volunteers
- 284 people
- Sponsor
- Advantage Dental Services, LLC
Colorectal Cancer
Zalutumumab With or Without Irinotecan Chemotherapy in Cetuximab-Refractory Colorectal Cancer
The purpose of this trial is to determine the safety and efficacy of Zalutumumab alone or in combination with Irinotecan for the treatment of patients with Colorectal Cancer
- Trial name
- GEN206 (NCT00677924)
- Testing
- Zalutumumab
- Where
- 3 sites in Belgium
- Volunteers
- 9 people
- Sponsor
- Genmab
Vulvar Cancer
Topical Imiquimod in Treating Patients With Recurrent Paget's Disease of the Vulva
RATIONALE: Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing.
- Trial name
- NCT00504023
- Testing
- imiquimod, biopsy, therapeutic conventional surgery
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Malignant Melanoma, Neoplasms
A Pharmacokinetics Study to Investigate the Effect of Vemurafenib on Digoxin in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma
This open-label, multi-center, three-period, one sequence study will investigate the effect of vemurafenib on the pharmacokinetics of digoxin in patients with unresectable BRAFV600-mutation positive metastatic melanoma or other…
- Trial name
- NCT01765569
- Testing
- Digoxin, Vemurafenib
- Where
- 13 sites in Belarus, Israel and 3 more
- Volunteers
- 29 people
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers, Breast Cancer
Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry and Tumor Imaging Potential of [131I]-SGMIB Anti-HER2 VHH1 in Healthy Volunteers and Breast Cancer Patients
Primary purpose of the clinical study is to evaluate the safety, biodistribution and radiation dosimetry of [131I]-SGMIB Anti-HER2 VHH1 in healthy volunteers and patients with HER2+ breast cancer.
- Trial name
- CAM-VHH1 (NCT02683083)
- Testing
- [131I]-SGMIB Anti-HER2 VHH1
- Where
- Belgium
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Precirix
Myelodysplastic Syndrome
Vosaroxin for Intermediate 2 or High-risk MDS After Failure With Hypomethylating Agent-based Therapy
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…
- Trial name
- NCT01980056
- Testing
- Vosaroxin
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Weill Medical College of Cornell University
Parkinson's Disease, Multiple Sclerosis
Blood Lactate Concentrations With and Without Exercise in Parkinson's Disease and Multiple Sclerosis Patients
Fatigue is one of the most common and debilitating symptoms experienced in Parkinson's Disease (PD) and Multiple Sclerosis (MS).
- Trial name
- PDMSLac (NCT02184494)
- Testing
- pro5 AIRdaptive Power Plate (Badhoevedorp, The Netherlands)
- Where
- 2 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Florida State University
Acute GvHD
Exploratory Safety Study of ALD518 in Subjects With Steroid-refractory Acute Graft Versus Host Disease (GVHD)
The purpose of this study is to determine the safe and tolerable, biologically active, and potentially effective doses(s) of ALD518 in subjects with acute GVHD, who have failed to respond to glucocorticosteroids, for further…
- Trial name
- ALD518-010 (NCT01530256)
- Testing
- ALD518
- Where
- 5 sites in United States
- Volunteers
- 3 people
- Sponsor
- CSL Behring
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