Clinical trials: Oral Phase
Solid Tumor, Metastatic Bladder Cancer
Dose-Finding and Safety Study for Oral Single-Agent to Treat Advanced Malignancies
The purpose of this study is to determine the maximum tolerated dose of RX-3117 in subjects with advanced or metastatic solid tumors (Phase 1).
- Trial name
- NCT02030067
- Testing
- RX-3117
- Where
- 12 sites in United States
- Volunteers
- 127 people
- Sponsor
- Processa Pharmaceuticals
Healthy Volunteers
A Study to Evaluate the Effect of Single-Dose Intravenous Rifampin as a Prototypic Inhibitor of Organic Anion Transporting Polypeptide (OATP) 1B1 and OATP1B3 on the Single-Dose Pharmacokinetics (PK) of Oral TAK-906 in Healthy Adult Participants
The purpose of this study is to evaluate the effect of single dose intravenous rifampin on the single-dose PK of orally administered TAK-906.
- Trial name
- NCT04121078
- Testing
- TAK-906, Rifampin
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Participants With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS).
The purpose of the study is to determine the maximal tolerated dose and schedule of CC-486, known as oral azacitidine, in patients with AML or MDS after allogeneic hematopoetic stem cell transplant (HSCT).
- Trial name
- NCT01835587
- Testing
- CC-486
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 31 people
- Sponsor
- Celgene
Healthy Participants
A Pharmacokinetic Study of TAK-438 in Healthy Adult Chinese Participants
The purpose of this study is to determine the pharmacokinetics (PK) of TAK-438 in healthy adult Chinese participants after both single and multiple dose administration.
- Trial name
- NCT03085836
- Testing
- TAK-438
- Where
- China
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Takeda
Castration-Resistant Prostate Cancer
Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy
This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.
- Trial name
- AFFIRM (NCT00974311)
- Testing
- Enzalutamide
- Where
- 249 sites in United States, Argentina and 13 more
- Volunteers
- 1,199 people
- Sponsor
- Pfizer
Chronic Kidney Disease, Anemia
Study of Roxadustat in Non-Dialysis Chronic Kidney Disease Participants With Anemia
The primary purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with non-dialysis chronic kidney disease.
- Trial name
- NCT01244763
- Testing
- Roxadustat
- Where
- 38 sites in United States, Puerto Rico
- Volunteers
- 145 people
- Sponsor
- Kyntra Bio
Pulmonary Disease, Chronic Obstructive, Lung Diseases
A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease
PF-03635659 is being developed for the treatment of chronic obstructive pulmonary disease. This is a study to examine the safety, pharmacokinetics and pharmacodynamics of PF-03635659 in patients with Chronic Obstructive Pulmonary…
- Conditions
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Respiratory Tract Diseases, Chronic Obstructive Airway Disease
- Trial name
- NCT01033487
- Testing
- active comparator, Low Dose PF-03635659, Mid Dose PF-03635659
- Where
- Germany
- Volunteers
- 22 people
- Sponsor
- Pfizer
Advanced or Recurrent Solid Tumors, Breast Neoplasms
Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors
This is a single-arm, open-label study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of talazoparib in patients with advanced tumors with DNA-repair pathway deficiencies.
- Conditions
- Advanced or Recurrent Solid Tumors, Breast Neoplasms, Ovarian Cancer, Epithelial, Ewing Sarcoma
- Trial name
- NCT01286987
- Testing
- Talazoparib
- Where
- 15 sites in United States, United Kingdom
- Volunteers
- 113 people
- Sponsor
- Pfizer
Healthy
Effect of BI 207127 + Faldaprevir on Blood Levels of Oral Contraceptives Containing Ethinylestradiol and Levonorgestrel
Investigate the effect of multiple oral doses of BI 207127 + faldaprevir (FDV) on the multiple dose pharmacokinetics of ethinylestradiol and levonorgestrel (Microgynon®) in healthy premenopausal female volunteers.
- Trial name
- NCT01941615
- Testing
- faldaprevir, Microgynon®, BI 207127
- Where
- Germany
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Glioblastoma, Glioblastoma Multiforme
Oral Pazopanib Plus Oral Topotecan Metronomic Antiangiogenic Therapy for Recurrent Glioblastoma Multiforme (A) Without Prior Bevacizumab Exposure and (B) After Failing Prior Bevacizumab
Background: Glioblastoma is the most common and most aggressive type of malignant brain tumor. The drug pazopanib is used to treat people with a type of kidney cancer. Topotecan is used to treat lung cancer.
- Conditions
- Glioblastoma, Glioblastoma Multiforme, Gliosarcoma, Brain Neoplasms
- Trial name
- NCT01931098
- Testing
- topotecan, pazopanib
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- National Cancer Institute (NCI)
Atopic Dermatitis
Efficacy and Safety Study of Orally Administered DS107 in Moderate to Severe Atopic Dermatitis Patients
The purpose of this study is to determine whether orally administered DS107 (1g and 2g doses) is effective in the treatment of moderate to severe atopic dermatitis.
- Trial name
- NCT02864498
- Testing
- DS107
- Where
- 2 sites in United States, South Africa
- Volunteers
- 321 people
- Sponsor
- DS Biopharma
Pulmonary Disease, Chronic Obstructive
Investigation of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of Oral Danirixin in Symptomatic COPD Subjects With Mild to Moderate Airflow Limitation at Risk for Exacerbations
The aim of this First Time in Patient study is to obtain initial information on the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of repeat daily administration of danirixin in subjects with…
- Trial name
- NCT02130193
- Testing
- Danirixin
- Where
- 16 sites in United States, Germany
- Volunteers
- 102 people
- Sponsor
- GlaxoSmithKline
Advanced Solid Tumors, Non-small Cell Lung Cancer
Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer
This is the first human study to use X-396 (ensartinib), a drug being developed for treatment of advanced cancers. The initial purpose of the study is to determine the largest amount of X-396 that can be safely given to humans…
- Trial name
- NCT01625234
- Testing
- Phase I: X-396 (ensartinib), Phase II: X-396 (ensartinib)
- Where
- 14 sites in United States
- Volunteers
- 131 people
- Sponsor
- Xcovery Holdings, Inc.
Oral Mucositis
Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers
The purpose of this study is to determine if RRx-001, which is added on to the cisplatin and radiation treatment, reduces the duration or length of severe oral mucositis in patients with head and neck cancers.
- Trial name
- PREVLAR (NCT03515538)
- Testing
- RRx-001, Cisplatin for injection, Radiation Therapy
- Where
- 12 sites in United States
- Volunteers
- 53 people
- Sponsor
- EpicentRx, Inc.
Healthy
A Study In Japanese Healthy Male Volunteers To Investigate The Safety, Tolerability And Pharmacokinetics Of PF-02341066
The purpose of this study is to investigate the pharmacokinetics of single doses of PF-02341066 (150, 250, and 400 mg) in the fasted condition in Japanese healthy male volunteers.
- Trial name
- NCT01250730
- Testing
- PF-02341066
- Where
- Japan
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer
Parkinson's Disease
Phase I, KM-819 in Healthy Subjects for Parkinson's Disease
This first in human, single-center, randomized, placebo-controlled, double blind, sequential group Phase 1 study in healthy subjects will be conducted to evaluate the safety, tolerability, PK, and PD following the escalation of…
- Trial name
- NCT03022799
- Testing
- KM-819
- Where
- South Korea
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Kainos Medicine Inc.
Recurrent Vulvovaginal Candidiasis
Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)
This study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female subjects 12 years and older…
- Trial name
- CANDLE (NCT04029116)
- Testing
- Fluconazole Tablet, IBREXAFUNGERP
- Where
- 25 sites in United States
- Volunteers
- 440 people
- Sponsor
- Scynexis, Inc.
Schizophrenia
A Study to Investigate the Efficacy, Safety and Tolerability of Four Different Doses of BI 409306 Compared to Placebo Given for 12 Weeks in Patients With Schizophrenia on Stable Antipsychotic Treatment.
The objective of the study is to investigate the efficacy, safety and tolerability of four different doses of BI 409306 once daily compared to placebo given for 12 weeks in patients with schizophrenia on stable antipsychotic…
- Trial name
- NCT02281773
- Testing
- BI 409306 100 mg QD, BI 498306 50 mg QD, BI 498306 25 mg QD
- Where
- 43 sites in United States, Canada and 3 more
- Volunteers
- 518 people
- Sponsor
- Boehringer Ingelheim
Bacterial Infections
Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections
The purpose of this study is to evaluate the pharmacokinetics of a single dose of intravenous or oral omadacycline in children and adolescents with suspected or confirmed bacterial infections.
- Trial name
- NCT05217537
- Testing
- Omadacycline Injection [Nuzyra], Omadacycline Oral Tablet
- Where
- 9 sites in United States
- Volunteers
- 23 people
- Sponsor
- Paratek Pharmaceuticals Inc
HNSCC, Lip SCC
Pembrolizumab Combined With Cetuximab for Treatment of Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma
This is a prospective, multi-center, open-label, non-randomized, multi-arm phase II trial to evaluate the efficacy of combination therapy with pembrolizumab and cetuximab for patients with recurrent/metastatic HNSCC.
- Conditions
- HNSCC, Lip SCC, Oral Cavity Cancer, Oropharynx Cancer
- Trial name
- NCT03082534
- Testing
- Pembrolizumab, Cetuximab
- Where
- 4 sites in United States
- Volunteers
- 78 people
- Sponsor
- University of California, San Diego
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