Clinical trials: Oral Chemotherapy
Healthy Volunteers
Safety, Tolerability, and Pharmacokinetics of Multiple-Dose TAK-058 in Healthy Participants
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of TAK-058 in healthy non-elderly and elderly participants.
- Trial name
- NCT02389881
- Testing
- TAK-058
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Takeda
Non-small Cell Lung Cancer
A Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen
This study will compare PF-00299804 given orally on continuous schedule to the approved drug, erlotinib, in patients whose non-small cell lung cancer has progressed after chemotherapy; patients will be randomized to receive one…
- Trial name
- NCT00769067
- Testing
- Erlotinib, PF-00299804
- Where
- 59 sites in United States, Australia and 10 more
- Volunteers
- 188 people
- Sponsor
- Pfizer
Oral Mucositis
Safety and Efficacy of ALD518 for Reducing Oral Mucositis in Head and Neck Cancer Subjects
The purpose of this study is to evaluate the safety and efficacy of ALD518 in modifying the course of oral mucositis in subjects with head and neck cancer receiving concomitant chemotherapy and radiotherapy
- Trial name
- NCT01403064
- Testing
- ALD518, 0.9% saline
- Where
- 31 sites in United States, Australia and 4 more
- Volunteers
- 76 people
- Sponsor
- CSL Behring
Gout
Food Effect Study of Febuxostat XR in Healthy Participants
The purpose of this study is to assess the effect of food on the bioavailability of febuxostat after a single oral dose of 80 mg febuxostat XR and to evaluate the pharmacokinetics (PK) of febuxostat after single oral doses of 40…
- Trial name
- NCT02374164
- Testing
- Febuxostat XR
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Takeda
Head and Neck Cancer, Oral Mucositis
Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck Cancer
GTI-4419-202 is a Phase 2 open-label study of the effects of GC4419 (IV) when administered in combination with IMRT and cisplatin to up to subjects with head and neck cancer, who are at high risk for Severe Oral Mucositis (SOM)
- Trial name
- NCT04529850
- Testing
- Drug: GC4419, Intensity-modulated radiation therapy (IMRT), Cisplatin
- Where
- 24 sites in Belgium, Czechia and 4 more
- Volunteers
- 38 people
- Sponsor
- Galera Therapeutics, Inc.
Friedreich Ataxia
Efficacy, Tolerability, and Pharmacokinetics of Multiple Doses of Oral TAK-831 in Adults With Friedreich Ataxia
The purpose of this study is to evaluate the efficacy of TAK-831 versus placebo on upper extremity (arm and hands) motor function and manual dexterity.
- Trial name
- NCT03214588
- Testing
- TAK-831
- Where
- 6 sites in United States
- Volunteers
- 67 people
- Sponsor
- Neurocrine Biosciences
Uterine Fibroids
A Phase 3 Study to Evaluate the Efficacy and Safety of Relugolix (TAK-385) 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids
The purpose of this study is to evaluate the efficacy of Relugolix (TAK-385) 40 mg administered orally once daily for 12 weeks, compared with leuprorelin injection (once every 4 weeks, 1.88 mg or 3.75 mg subcutaneously [SC]/time)…
- Trial name
- NCT02655237
- Testing
- Relugolix, Leuprorelin
- Where
- 25 sites in Japan
- Volunteers
- 281 people
- Sponsor
- Takeda
Hepatic Impairment, Healthy Volunteers
A Study of Soticlestat in Adults With Liver Failure Compared to Those With Normal Liver Function
The main aim is to check the effect of a single dose of soticlestat in adults with moderate or mild liver failure compared to healthy adults with normal liver function. Participants will check into the study clinic for 8 days.
- Trial name
- NCT05098054
- Testing
- Soticlestat
- Where
- 6 sites in United States, Hungary
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Takeda
Acute Myeloid Leukemia (AML)
A Study of Oral Venetoclax Tablets and Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose (RPTD) of venetoclax in combination with azacitidine (AZA).
- Trial name
- VIALE-M (NCT04102020)
- Testing
- Venetoclax, Azacitidine
- Where
- 156 sites in United States, Australia and 17 more
- Volunteers
- 112 people
- Sponsor
- AbbVie
Thrombocytopaenia
Safety and Efficacy Study for Solid Tumor Patients Treated With Eltrombopag
The present study is a randomized, blinded, placebo-controlled, two-Phase, sequential cohort, dose finding study to assess the safety and efficacy of eltrombopag in patients with solid tumors receiving gemcitabine monotherapy or…
- Trial name
- NCT01147809
- Testing
- Eltrombopag olamine
- Where
- 86 sites in United States, Belgium and 11 more
- Volunteers
- 130 people
- Sponsor
- GlaxoSmithKline
Carcinoma, Non-Small-Cell Lung
LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research
The present trial will investigate the efficacy and safety of nintedanib in combination with docetaxel as compared to placebo in combination with docetaxel in patients with stage IIIB/IV or recurrent NSCLC of adenocarcinoma…
- Trial name
- NCT02231164
- Testing
- docetaxel, nintedanib
- Where
- 13 sites in United States, Georgia and 1 more
- Volunteers
- 12 people
- Sponsor
- Boehringer Ingelheim
Healthy
Effects of Vortioxetine (Lu AA21004) on the Concentrations of Selected Neurotransmitters in Healthy Male Adults
The purpose of this study is to evaluate the pharmacodynamics (the drug's effect on the body), the pharmacokinetics (the body's handling of the drug), and the safety and tolerability of vortioxetine, once daily (QD) in healthy…
- Trial name
- NCT01299805
- Testing
- Vortioxetine
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Takeda
Prostate Cancer
Safety and Efficacy of TAK-385 for Patients With Localized Prostate Cancer
The purpose of this study is to evaluate the efficacy of TAK-385 for achieving and maintaining testosterone suppression.
- Trial name
- NCT02135445
- Testing
- TAK-385, Degarelix
- Where
- 25 sites in United States, United Kingdom
- Volunteers
- 103 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Prostate Cancer
Phase 2 Trial of Enzastaurin in Prostate Cancer in Participants Who Have Had Hormonal and Chemotherapy
The purpose is to see how quickly two different types of prostate cancer participants respond when taking enzastaurin. Cohort 1 - asymptomatic participants with androgen-independent prostate-specific antigen (PSA)-progressive…
- Trial name
- NCT00428714
- Testing
- enzastaurin
- Where
- 11 sites in United States
- Volunteers
- 73 people
- Sponsor
- Eli Lilly and Company
Gout
Dose-Response, Safety and Efficacy of Febuxostat in Subjects With Gout
The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), in reducing serum urate levels in subjects with gout.
- Trial name
- NCT00174967
- Testing
- Febuxostat
- Volunteers
- 153 people
- Sponsor
- Takeda
Healthy Volunteers, Schizophrenia
Phase 1 TAK-041 First-in-Human Safety, Tolerability, and Pharmacokinetics Study
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of TAK-041: 1. Following oral single and multiple doses in healthy participants. 2.
- Trial name
- NCT02748694
- Testing
- TAK-041
- Where
- United States
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Neurocrine Biosciences
Anemia, Iron-Deficiency, Kidney Failure, Chronic
Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents
This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are receiving erythropoietic agents…
- Trial name
- NCT00224042
- Testing
- Sodium Ferric Gluconate complex in sucrose, Ferrous sulfate tablets
- Where
- 24 sites in United States, Puerto Rico
- Volunteers
- 52 people
- Sponsor
- Watson 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.
Chemotherapy-induced Nausea and Vomiting
A Study to Assess the Safety and the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination for the Prevention of CINV in AC Chemotherapy in Women With Breast Cancer
Multicenter, randomized, double-blind, double-dummy, parallel group, stratified study assessing the safety and describing the efficacy of a single dose of intravenous (IV) fosnetupitant/palonosetron (260 mg/0.25 mg) infusion…
- Trial name
- NCT03403712
- Testing
- fosnetupitant/ palonosetron, netupitant/palonosetron, dexamethasone
- Where
- 40 sites in United States, Georgia
- Volunteers
- 404 people
- Sponsor
- Helsinn Healthcare SA
Carcinoma, Non-Small-Cell Lung
Nintedanib Plus Docetaxel in Japanese Patients With Adenocarcinoma Subtype Non-small Cell Lung Cancer After Failure of First Line Chemotherapy
To determine the appropriateness of the dose of nintedanib 200 mg b.i.d. plus docetaxel 75 mg/m2 as starting dose by evaluating the safety in Japanese patients with body surface area (BSA) <1.5 m2 and locally advanced or…
- Trial name
- NCT02300298
- Testing
- Nintedanib, Docetaxel
- Where
- 6 sites in Japan
- Volunteers
- 10 people
- Sponsor
- Boehringer Ingelheim