Clinical trials: Phase I
Breast Cancer
A Pharmacokinetic and Randomized Trial of Neoadjuvant Treatment With Anastrozole Plus AZD0530 in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer
The investigators propose to conduct a Phase I/randomized Phase II study design in order to test the tolerability and efficacy of AZD0530 (also called saracatinib) when used together with anastrozole in therapy for ER+ and/or…
- Trial name
- NCT01216176
- Testing
- Anastrozole, AZD0530 (saracatinib)
- Where
- 2 sites in United States
- Volunteers
- 71 people
- Sponsor
- Joyce Marie Slingerland, MD
Refractory Multiple Myeloma, Multiple Myeloma in Relapse
Study of Ibrutinib in Combination With Revlimid/Dexamethasone in Relapsed/Refractory Multiple Myeloma
This is a registration, open-label phase 1 study of the combination of ibrutinib/lenalidomide:/dexamethasone in women and men with relapsed/refractory multiple myeloma.
- Conditions
- Refractory Multiple Myeloma, Multiple Myeloma in Relapse, Multiple Myeloma
- Trial name
- NCT03702725
- Testing
- Ibrutinib, Lenalidomide, Dexamethasone
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- Alliance Foundation Trials, LLC.
Recurrent Acute Myeloid Leukemia, Recurrent Myelodysplastic Syndrome
Pevonedistat and Belinostat in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
This phase I trial studies side effects and best dose of pevonedistat and belinostat in treating patients with acute myeloid leukemia or myelodysplastic syndrome that has come back (relapsed) or does not respond to treatment…
- Conditions
- Recurrent Acute Myeloid Leukemia, Recurrent Myelodysplastic Syndrome, Refractory Acute Myeloid Leukemia, Refractory Myelodysplastic Syndrome
- Trial name
- NCT03772925
- Testing
- Belinostat, Pevonedistat
- Where
- 6 sites in United States
- Volunteers
- 18 people
- Sponsor
- National Cancer Institute (NCI)
Attention-Deficit/Hyperactivity Disorder
Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of TAK-137 in Adults With Attention-Deficit/Hyperactivity Disorder.
The purpose of this study is to characterize the safety and tolerability of TAK-137 when administered as multiple oral doses in adults with attention-deficit/hyperactivity disorder (ADHD).
- Trial name
- NCT02163915
- Testing
- TAK-137
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Takeda
Disorder of Urinary Stent
The Effect of Terazosin and Tolterodine on Ureteral Stent Related Symptoms
The aim of the investigators study is to evaluate whether alpha-blockers such as terazosin and anti-cholinergics such as tolterodine can be relieve the DJ-stent related symptoms.
- Trial name
- NCT01530243
- Testing
- Terazosine, Tolterodine, Tolterodine + Terazosin
- Where
- Iran
- Volunteers
- 104 people
- Sponsor
- Urmia University of Medical Sciences
Anal Cancer
Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer
RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
- Trial name
- NCT00324415
- Testing
- cetuximab, cisplatin, fluorouracil
- Where
- 7 sites in United States
- Volunteers
- 45 people
- Sponsor
- AIDS Malignancy Consortium
Multiple Myeloma
Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of GSK2857916
This study will assess the safety, pharmacokinetic (PK), pharmacodynamic (PD) and the therapeutic potential of GSK2857916 in subjects with multiple myeloma (MM) and lymphomas that express B cell maturation antigen (BCMA).
- Trial name
- NCT02064387
- Testing
- GSK2857916
- Where
- 9 sites in United States, Canada and 1 more
- Volunteers
- 79 people
- Sponsor
- GlaxoSmithKline
Cancer
Aprepitant in Preventing Nausea and Vomiting in Patients Who Are Undergoing a Stem Cell Transplant
RATIONALE: Antiemetic drugs, such as aprepitant, ondansetron, and dexamethasone, may help lessen or prevent nausea and vomiting in patients undergoing a stem cell transplant.
- Trial name
- NCT00248547
- Testing
- aprepitant, dexamethasone, ondansetron
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- OHSU Knight Cancer Institute
Infection, Human Immunodeficiency Virus, HIV Infections
Pharmacokinetic Study of Cabotegravir Long-acting in Healthy Adult Volunteers
Cabotegravir (CAB) long-acting (LA) is a promising candidate for human immunodeficiency virus (HIV) pre exposure prophylaxis (PrEP) due to its potent antiretroviral activity and infrequent dosing requirements.
- Trial name
- NCT02478463
- Testing
- Cabotegravir tablet 30 mg once daily for 28 days., Cabotegravir injection 3 mL (200 mg/mL) IM given once on Day 1.
- Where
- 2 sites in United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Advanced Hepatocellular Carcinoma (HCC)
MGD013 Monotherapy and Combination With Brivanib Dose Escalation and Expansion Study in Advanced Liver Cancer Patients
This study consists of two parts: Phase I is a dose escalation study to determine the Recommended Phase II Dose (RP2D) of MGD013 monotherapy and that of MGD013 when in combination with Brivanib Alaninate (ZL-2301) in subjects…
- Trial name
- NCT04212221
- Testing
- MGD013 monotherapy, MGD013 in combination with Brivanib Alaninate
- Where
- China
- Volunteers
- 89 people
- Sponsor
- Zai Lab (Shanghai) Co., Ltd.
Pathologic Stage IIA-IIIC Triple-Negative Breast Cancer, TNBC - Triple-Negative Breast Cancer
Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer
The purpose of this study is to determine the safety as well as the most effective dose of the alpha-lactalbumin vaccine (aLA breast cancer vaccine) to treat patients with non-metastatic triple negative breast cancer…
- Conditions
- Pathologic Stage IIA-IIIC Triple-Negative Breast Cancer, TNBC - Triple-Negative Breast Cancer, Residual Disease
- Trial name
- NCT04674306
- Testing
- α-lactalbumin vaccine, Zymosan
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- George T. Budd
Blasts More Than 20 Percent of Bone Marrow Nucleated Cells, Blasts More Than 20 Percent of Peripheral Blood White Cells
Ruxolitinib Phosphate and Decitabine in Treating Patients With Relapsed or Refractory or Post Myeloproliferative Acute Myeloid Leukemia
This phase I/II trial studies the side effects and best dose of ruxolitinib phosphate when given together with decitabine and to see how well they work in treating patients with acute myeloid leukemia that has come back or is not…
- Conditions
- Blasts More Than 20 Percent of Bone Marrow Nucleated Cells, Blasts More Than 20 Percent of Peripheral Blood White Cells, Myelodysplastic/Myeloproliferative Neoplasm, Recurrent Acute Myeloid Leukemia
- Trial name
- NCT02257138
- Testing
- Decitabine, Laboratory Biomarker Analysis, Ruxolitinib Phosphate
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- M.D. Anderson Cancer Center
Non-Small-Cell Lung Cancer
A Study of Pemetrexed Plus Carboplatin, or Pemetrexed Plus Cisplatin With Radiation Therapy Followed by Pemetrexed in Patients With Inoperable Non-Small-Cell Lung Cancer
The primary purpose of this study is to determine the 2-year survival rate of both of the chemotherapy regimens in patients with inoperable non-small-cell lung cancer.
- Trial name
- NCT00482014
- Testing
- pemetrexed, cisplatin, carboplatin
- Where
- 11 sites in United States, India
- Volunteers
- 120 people
- Sponsor
- Eli Lilly and Company
Progressive Multiple Sclerosis
A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis
This study aims to identify the safety and tolerability of bile acid supplementation in patients with progressive Multiple Sclerosis (MS).
- Trial name
- NCT03423121
- Testing
- Tauroursodeoxycholic Acid
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Johns Hopkins University
HER-2 Positive Breast Cancer
Study of Neoadjuvant Carboplatin, Eribulin and Trastuzumab for Operable HER2 Positive Breast Cancer
This study will evaluate the safety and efficacy of eribulin in combination with carboplatin and trastuzumab in the neoadjuvant setting in subjects who are human epidermal growth factor receptor (HER)2 positive and are clinically…
- Trial name
- NCT01388647
- Testing
- eribulin, carboplatin, trastuzumab
- Where
- 4 sites in United States
- Volunteers
- 12 people
- Sponsor
- Vector Oncology
Advanced Solid Neoplasm
A Study to Evaluate the Effects of Pevonedistat on the Corrected QT (QTc) Interval in Participants With Advanced Solid Tumors
The purpose of this study is to characterize the effects of 25 and 50 milligram per square meter (mg/m^2) pevonedistat on the Fridericia corrected QT interval (QTcF) of the electrocardiogram (ECG).
- Trial name
- NCT03330106
- Testing
- Pevonedistat, Docetaxel, Carboplatin
- Where
- 8 sites in United States
- Volunteers
- 68 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Respiratory Syncytial Virus Infections
A Study to Test GlaxoSmithKline's (GSK) Respiratory Syncytial Virus RSV Candidate Vaccine's Safety and Immune Response in Japanese Older Adults
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2 doses of GSK Biologicals' RSV candidate vaccine adjuvanted with AS01B for the prevention of lower respiratory tract diseases caused by…
- Trial name
- NCT04090658
- Testing
- RSV_PreF3 Vaccine (GSK3844766A) adjuvanted with AS01B
- Where
- Japan
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV-1 Infection
Study to Evaluate Effects of Vorinostat and HXTC on Persistent HIV-1 Infection in HIV-Infected Subjects Started on Antiretroviral Therapy (ART)
This is a phase I, single-site, study to evaluate the effects of VOR and HIV-1 Antigen Expanded Specific T Cell Therapy (HXTC) on persistent HIV-1 Infection in HIV-infected individuals suppressed on ART.
- Trial name
- XTRA (NCT03212989)
- Testing
- Vorinostat, HXTC
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- University of North Carolina, Chapel Hill
Liver Diseases, Healthy
Influence of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Various Doses of Afatinib
Up to 38 subjects entered with the aim of entering 8 subjects with mild liver impairment (at highest dose of afatinib), 8 subjects with moderate liver impairment (at either highest dose or two lower doses) and 8 healthy matched…
- Trial name
- NCT01298063
- Testing
- Afatinib
- Where
- Germany
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteer
Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants
This study will evaluate the pharmacokinetics, safety and tolerability of a single oral dose of baloxavir marboxil (40 mg or 80 mg) in healthy Chinese participants.
- Trial name
- NCT03959332
- Testing
- Baloxavir Marboxil
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
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