Clinical trials: Phase I
Achromatopsia
Long-Term Follow-Up Gene Therapy Study for Achromatopsia CNGB3 and CNGA3
This is a longer-term follow-up study of patients with achromatopsia associated with defects in CNGA3 who participated in a clinical trial in which they received AAV-CNGA3 retinal gene therapy, or of patients with achromatopsia…
- Trial name
- NCT03278873
- Testing
- Prior exposure to AAV-CNGA3 or AAV-CNGB3
- Where
- 2 sites in United States, United Kingdom
- Volunteers
- 34 people
- Sponsor
- MeiraGTx UK II Ltd
Neoplasms, Neoplasm Metastasis
A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread
The main objective of the dose-escalation parts of the trial is to determine the maximum tolerated dose (MTD), based on the frequency of patients experiencing dose-limiting toxicities (DLTs), and/or the recommended dose for…
- Conditions
- Neoplasms, Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung
- Trial name
- NCT03166631
- Testing
- BI 891065, BI 754091
- Where
- 3 sites in United States
- Volunteers
- 62 people
- Sponsor
- Boehringer Ingelheim
Pancreatic Ductal Adenocarcinoma
BMS-813160 With Nivolumab and Gemcitabine and Nab-paclitaxel in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)
The purpose of this research study is to learn more about a new combination of drugs being given to treat pancreatic cancer. The drugs being tested are BMS-813160, nivolumab, gemcitabine, and nab-paclitaxel.
- Trial name
- NCT03496662
- Testing
- BMS-813160, Nivolumab, Gemcitabine
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Washington University School of Medicine
Biological Availability
A Study to Learn About the Study Medication, Zavegepant, in Healthy Volunteers
This trial is designed to compare the rate and extent of absorption of four different formulations of zavegepant. 52 healthy male and female volunteers will receive a single dose of each formulation at least 7 days apart over a…
- Trial name
- NCT06137703
- Testing
- Zavegepant 100mg non-enteric coated soft gel capsule, Zavegepant 100mg immediate release tablet, Zavegepant 2 x 100mg immediate release tablets
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Pfizer
Brain and Central Nervous System Tumors
Imatinib Mesylate With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed or Recurrent Glioma
Phase I/II trial to estimate the maximum tolerated dose of imatinib mesylate in newly diagnosed brain stem gliomas and recurrent high grade gliomas and to assess the effectiveness of imatinib mesylate in treating young patients…
- Trial name
- NCT00021229
- Testing
- imatinib mesylate, local irradiation therapy
- Where
- 10 sites in United States
- Volunteers
- 85 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer, Chemotherapeutic Agent Toxicity
S0715: Acetyl-L-Carnitine in Preventing Neuropathy in Women With Stage I, II, or IIIA Breast Cancer Undergoing Chemo
RATIONALE: Acetyl-L-carnitine may prevent or lessen neuropathy caused by chemotherapy. It is not yet known whether acetyl-L-carnitine is more effective than a placebo in preventing neuropathy caused by chemotherapy.
- Conditions
- Breast Cancer, Chemotherapeutic Agent Toxicity, Fatigue, Neuropathy
- Trial name
- NCT00775645
- Testing
- acetyl-L-carnitine hydrochloride
- Where
- 295 sites in United States
- Volunteers
- 437 people
- Sponsor
- SWOG Cancer Research Network
Herpes Simplex
Neonatal Phase 1 Valacyclovir Study
A Phase 1 study that will determine the valacyclovir dose that results in a systemic acyclovir exposure comparable to 10 mg/kg of parenterally administered acyclovir, which is an AUC0-12 of 24,000 ngxhr/mL to 48,000 ngxhr/mL.
- Trial name
- NCT05468619
- Testing
- Valacyclovir
- Where
- 12 sites in United States
- Volunteers
- 17 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Marginal Zone
A Study of TAK-659 as a Single Agent in Adult East Asian Participants With Non-Hodgkin Lymphoma (NHL)
The purpose of this study is to determine the safety, tolerability, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of TAK-659 when administered in East Asian participants with NHL who do not have an effective…
- Trial name
- NCT03238651
- Testing
- TAK-659
- Where
- 4 sites in Japan, South Korea
- Volunteers
- 17 people
- Sponsor
- Calithera Biosciences, Inc
Recurrent Glioblastoma, Recurrent Gliosarcoma
Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma
This is a phase 0/1 dose-escalation trial to determine the maximum tolerated dose of Mycophenolate Mofetil (MMF) when administered with radiation, in patients with glioblastoma or gliosarcoma.
- Conditions
- Recurrent Glioblastoma, Recurrent Gliosarcoma, Recurrent Astrocytoma, Grade IV, Newly Diagnosed Glioblastoma
- Trial name
- NCT04477200
- Testing
- Mycophenolate Mofetil, Radiation Therapy, Re-resection (as part of standard of care)
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- University of Michigan Rogel Cancer Center
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
Volasertib in Combination With Azacitidine in Japanese Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
To identify the maximum tolerated dose or recommended dose for further development of volasertib in combination with azacitidine in Japanese patients with myelodysplastic syndromes or chronic myelomonocytic leukemia, and evaluate…
- Trial name
- NCT02201329
- Testing
- Azacitidine, Volasertib
- Where
- 4 sites in Japan
- Volunteers
- 5 people
- Sponsor
- Boehringer Ingelheim
Chronic Graft vs Host Disease, Chronic Graft-Versus-Host Disease
Study of Baricitinib, a JAK1/2 Inhibitor, in Chronic Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
Background: Chronic graft versus host disease (cGVHD) can affect people who had a hematopoietic stem cell transplant using donor cells. It is often fatal. It is usually treated with high doses of steroids.
- Trial name
- NCT02759731
- Testing
- Baricitinib
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- National Cancer Institute (NCI)
Human Immunodeficiency Virus Prevention, Human Immunodeficiency Virus (HIV)
Dose, Safety, Tolerability, and Immunogenicity of an HIV-1 Vaccine, VRC-HIVRGP096-00-VP, With Alum in Healthy Adults
Background: HIV stands for human immunodeficiency virus, which is the virus that causes AIDS. There is currently no licensed vaccine to prevent HIV infection.
- Trial name
- NCT03783130
- Testing
- VRC-HIVRGP096-00-VP, Alum Adjuvant
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
DS Stage I Multiple Myeloma, DS Stage II Multiple Myeloma
Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma
This randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma.
- Conditions
- DS Stage I Multiple Myeloma, DS Stage II Multiple Myeloma, DS Stage III Multiple Myeloma
- Trial name
- NCT00644228
- Testing
- Bortezomib, Dexamethasone, Laboratory Biomarker Analysis
- Where
- 498 sites in United States, Puerto Rico and 1 more
- Volunteers
- 525 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
Concurrent Adjuvant Carboplatin and Accelerated Radiotherapy for Triple Negative Breast Cancer
The purpose of this study is to determine the safety and effectiveness of a combination of chemotherapy and radiotherapy in breast cancer patients after breast surgery.
- Trial name
- NCT01289353
- Testing
- Carboplatin, 3D-RT or IMRT
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- NYU Langone Health
Recurrent Small Cell Lung Cancer
Rovalpituzumab Tesirine (SC16LD6.5) in Recurrent Small Cell Lung Cancer
The purpose of this study is to assess the safety and tolerability of rovalpituzumab tesirine (SC16LD6.5) at different dose levels in patients with small cell lung cancer whose cancer has progressed or recurred following standard…
- Trial name
- NCT01901653
- Testing
- Rovalpituzumab tesirine (SC16LD6.5)
- Where
- 8 sites in United States
- Volunteers
- 82 people
- Sponsor
- Stemcentrx
Lupus Erythematosus, Graft-versus-host Disease
Nonmyeloablative Conditioning and Transplantation for Patients With Refractory Systemic Lupus Erythematosus (SLE)
The main goal of the study is to determine if bone marrow transplant (BMT) from a less specific pool of donors in combination with high dose cyclophosphamide can induce remission of refractory systemic lupus erythematosus.
- Trial name
- NCT02080195
- Testing
- Cyclophosphamide, Fludarabine, Tacrolimus
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Solid Tumor, Gastric Cancer
Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 in Patients With Unresectable or Metastatic CLDN18.2-positive Gastric, Pancreatic, Ovarian and Biliary Tract Tumors
This study was planned as an open-label, multi-site, Phase I/IIa dose escalation, safety, and pharmacokinetic (PK) trial of BNT141 followed by expansion cohorts in patients with Claudin 18.2 (CLDN18.2)-positive tumors.
- Conditions
- Solid Tumor, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma
- Trial name
- NCT04683939
- Testing
- BNT141, Nab-paclitaxel, Gemcitabine
- Where
- 7 sites in United States, Canada
- Volunteers
- 13 people
- Sponsor
- BioNTech SE
Pneumococcal Infections
Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-028)
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 administered subcutaneously or intramuscularly in healthy Japanese infants (3 months of age).
- Trial name
- NCT03848065
- Testing
- V114, Pneumococcal 13-valent Conjugate Vaccine (PCV13), Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine (DTaP-IPV)
- Where
- 14 sites in Japan
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Metastatic Cancer, Metastatic Melanoma
CAR T Cell Receptor Immunotherapy Targeting VEGFR2 for Patients With Metastatic Cancer
Background: The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for treating patients metastatic cancer that involves taking white blood cells from the patient, growing them in the laboratory…
- Conditions
- Metastatic Cancer, Metastatic Melanoma, Renal Cancer
- Trial name
- NCT01218867
- Testing
- Anti-VEGFR2 CAR CD8 plus PBL, Cyclophosphamide, Aldesleukin
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- National Cancer Institute (NCI)
Healthy
Safety and Pharmacokinetics of Multiple Doses of BI 655064 in Healthy Chinese Male Volunteers
The primary objective of this trial is to investigate the safety and tolerability of multiple doses of BI 655064 following weekly subcutaneous injection for 4 weeks in healthy Chinese male volunteers.
- Trial name
- NCT02331277
- Testing
- BI 655064
- Where
- South Korea
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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