Clinical trials: Phase I
Motavizumab Administration for a Second Season for RSV Prophylaxis
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Motavizumab (MEDI-524) After Dosing for a Second Season in Children
The primary objective of this study was to determine the effect on immune reactivity to motavizumab (MEDI-524) of monthly intramuscular (IM) doses of motavizumab (MEDI-524) administered for a second season in children.
- Trial name
- NCT00113490
- Testing
- motavizumab (MEDI-524), palivizumab 15 mg/kg
- Where
- 6 sites in Brazil, Chile
- Volunteers
- 136 people
- Sponsor
- MedImmune LLC
HER2-positive Breast Cancer, Stage I Breast Cancer
Omission of Surgery in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti-HER2-based Neoadjuvant Therapy
This is a prospective, single arm, open-label, unicenter, exploratory study in women with primary operable HER2-positive, HER2-enriched/ERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff…
- Trial name
- ELPIS (NCT04578106)
- Testing
- Trastuzumab and pertuzumab Subcutaneous Fixed-Dose Combination
- Where
- Spain
- Volunteers
- 5 people
- Sponsor
- Fundacio Clinic Barcelona
Dry Eye Disease
Study of INV-102 Ophthalmic Solution in Adults With Moderate Symptomatic Dry Eye Disease
Phase 1/2, first-in-human, 2-part study to assess topically administered eyedrops of INV-102 during 2-week repeat dosing in subjects with moderate symptomatic dry eye disease.
- Trial name
- NCT05586152
- Testing
- INV-102, Vehicle
- Where
- United States
- Volunteers
- 84 people
- Sponsor
- Invirsa, Inc.
Nonalcoholic Steatohepatitis (NASH), Overweight or Obesity
A Study of FT 4101 in Overweight/Obese Participants With Non-alcoholic Steatohepatitis
This Phase 1/2 study will evaluate safety, efficacy, PK, and PD of FT-4101 as a single agent in overweight/obese subjects with NASH. The study may be conducted in up to 2 dosing cohorts.
- Trial name
- NCT04004325
- Testing
- FT-4101, Deuterated Water
- Where
- 2 sites in United States
- Volunteers
- 14 people
- Sponsor
- Forma Therapeutics, Inc.
Healthy
Study of Oral ALXN1840 at 2 Dose Strengths in Healthy Adults
To assess the relative bioavailability of ALXN1840 administered orally as a single enteric-coated (EC) tablet (reference, Treatment A) versus three EC tablets (test, Treatment B).
- Trial name
- NCT05303324
- Testing
- ALXN1840
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Head and Neck Neoplasm
Dose-Escalated Hypofractionated Adaptive Radiotherapy for Head and Neck Cancer
Locoregional failure remains the principal mode of mortality in head and neck squamous cell carcinoma (HNSCC) treated with conventional chemoradiation therapy.
- Trial name
- DEHART (NCT04477759)
- Testing
- 50 Gy Radiation Therapy, 55 Gy Radiation Therapy, 60 Gy Radiation Therapy
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Medical College of Wisconsin
Solid Tumors
Study of Safety and Pharmacokinetics of MK-8242 in Participants With Advanced Solid Tumors (P07650)
This study is being done to evaluate the safety and pharmacokinetic profile of MK-8242 and its active metabolite (M16) in participants with advanced solid tumors.
- Trial name
- NCT01463696
- Testing
- MK-8242
- Volunteers
- 48 people
- Sponsor
- Merck Sharp & Dohme LLC
Pancreatic Neoplasm
A Study On An Immunostimulant Antibody In Combination With Chemotherapy For Advanced Cancer Of The Pancreas
This study aims to seek evidence that activation of certain cells of the immune system will be safe and well tolerated in combination with cytotoxic chemotherapy.
- Trial name
- NCT00711191
- Testing
- monoclonal antibody, chemotherapy
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Hoffmann-La Roche
Thrombosis
Safety and Tolerability Study of E-WE Thrombin in Healthy Adult Subjects
The purpose of this study is to assess the safety, tolerability and pharmacodynamics of a single iv dose of E-WE Thrombin in healthy adult subjects.
- Trial name
- NCT03453060
- Testing
- E-WE Thrombin- Dose 1, E-WE Thrombin- Dose 2, E-WE Thrombin- Dose 3
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Aronora, Inc.
Lymphoma, Non-Hodgkin
Iodine-131 Anti-B1 Antibody (Tositumomab and Iodine I 131 Tositumomab) for Previously Untreated, Advanced-stage, Low Grade Non-Hodgkin's Lymphoma
This is a single-arm, single-institution, phase II study of Iodine-131 Anti-B1 Antibody for patients with previously untreated, advanced-stage (stage III or IV) low-grade non-Hodgkin's B-cell lymphoma.
- Trial name
- NCT00996996
- Testing
- Tositumomab and Iodine I 131 Tositumomab (Anti-B1 Antibody and Iodine-131 Anti-B1 Antibody)
- Volunteers
- 77 people
- Sponsor
- GlaxoSmithKline
Infantile Colic, Infantile Functional Gastrointestinal Disorders
A Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants
The purpose of the study is to evaluate the gastrointestinal absorption of nepadutant after single dose as oral solution (and the effect of age on its oral absorption) in infants.
- Trial name
- NCT00655083
- Testing
- Nepadutant
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- Menarini Group
Melanoma, Malignant Melanoma
Chemotherapy Followed by Infusion of DMF5 Cells to Treat Metastatic Melanoma
Background: This study will use cells called DMF5 to treat patients with metastatic melanoma (melanoma that has spread beyond the primary tumor site).
- Conditions
- Melanoma, Malignant Melanoma, Melanoma, Experimental
- Trial name
- NCT00924001
- Testing
- DMF5 Melanoma Reactive TIL, Cyclophosphamide, Fludarabine
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- National Cancer Institute (NCI)
Dry Eye
IVIG-eye Drops Treatment for Dry Eye Disease
The main objective of this study is to establish whether patients with Dry Eye Disease are able to safely tolerate receiving Intravenous Immunoglobulin (IVIG) eye drops two times a day for eight weeks (primary 'safety and…
- Trial name
- NCT03992482
- Testing
- Intravenous Immune Globulin (IVIG)
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Sandeep Jain, MD
Advanced Colorectal Adenomas, Adenocarcinoma of the Colon
Polyphenon E in Treating Patients With High-Risk of Colorectal Cancer
This phase II trial studies how well Polyphenon E works in treating patients with high-risk of colorectal cancer. Polyphenon E contains ingredients that may prevent or slow colorectal cancer.
- Conditions
- Advanced Colorectal Adenomas, Adenocarcinoma of the Colon, Stage I Colon Cancer, Stage II Colon Cancer
- Trial name
- NCT01606124
- Testing
- defined green tea catechin extract, questionnaire administration, laboratory biomarker analysis
- Where
- 3 sites in United States
- Volunteers
- 39 people
- Sponsor
- Mayo Clinic
Multiple Myeloma
Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat, Lenalidomide, and Dexamethasone in Participants With RRMM
The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with nirogacestat, lenalidomide, and dexamethasone, and to establish the recommended Phase 2 dose for combination treatment to…
- Trial name
- NCT07150091
- Testing
- Belantamab mafodotin, Nirogacestat, Lenalidomide
- Where
- 12 sites in United States, Brazil and 6 more
- Volunteers
- 20 people
- Sponsor
- GlaxoSmithKline
Ewing Sarcoma, PEComa
Nivolumab (Opdivo®) Plus ABI-009 (Nab-rapamycin) for Advanced Sarcoma and Certain Cancers
This study investigates the safety/toxicity and potential anti-tumor activity of sequential administration of nivolumab and escalating doses of the mammalian target of rapamycin (mTOR) inhibitor nab-rapamycin (ABI-009) in…
- Conditions
- Ewing Sarcoma, PEComa, Epithelioid Sarcoma, Desmoid Tumor
- Trial name
- NCT03190174
- Testing
- Nab-Rapamycin, Nivolumab
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Sarcoma Oncology Research Center, LLC
Glioblastoma Multiforme, Anaplastic Astrocytoma
Oral Tarceva Study for Recurrent/Residual Glioblastoma Multiforme and Anaplastic Astrocytoma
This study will offer a safe treatment for patients with relapsing recurring glioblastoma (GBM) or anaplastic astrocytoma (AA). The trial will test the hypothesis that Erlotinib (Tarceva, OSI-774) can be safely used up to a dose…
- Trial name
- NCT00301418
- Testing
- Erlotinib
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Northwell Health
Pancreatic Cancer, Non-small Cell Lung Cancer
Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Chemotherapy in Participants With Advanced Solid Tumors
The primary objective of the study is to determine the maximum tolerated dose of andecaliximab monotherapy and to evaluate the safety and tolerability of andecaliximab (formerly GS-5745) alone and in combination with…
- Conditions
- Pancreatic Cancer, Non-small Cell Lung Cancer, Esophagogastric Cancer, Colorectal Cancer
- Trial name
- NCT01803282
- Testing
- Andecaliximab, Gemcitabine, Nab-paclitaxel
- Where
- 18 sites in United States
- Volunteers
- 236 people
- Sponsor
- Gilead Sciences
Hepatic Impairment, Hepatic Insufficiency
Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite
This study is investigate the influence of severe hepatic impairment on the pharmacokinetics of acalabrutinib and its metabolite.
- Conditions
- Hepatic Impairment, Hepatic Insufficiency, Healthy Subjects
- Trial name
- NCT03968848
- Testing
- acalabrutinib
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
Recurrent Bladder Carcinoma, Stage I Bladder Cancer AJCC v6 and v7
Phase II Study of Isoflavone G-2535 (Genistein) in Patients With Bladder Cancer
Studying samples of blood, urine, and tissue from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
- Conditions
- Recurrent Bladder Carcinoma, Stage I Bladder Cancer AJCC v6 and v7, Stage II Bladder Cancer AJCC v6 and v7, Stage III Bladder Cancer AJCC v6 and v7
- Trial name
- NCT00118040
- Testing
- Genistein, Laboratory Biomarker Analysis, Pharmacological Study
- Where
- 10 sites in United States
- Volunteers
- 60 people
- Sponsor
- National Cancer Institute (NCI)
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