Clinical trials: Oral Chemotherapy
Multiple Myeloma
Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Participants With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation (SCT)
The purpose of this study is to determine the long-term safety and tolerability of ixazomib maintenance therapy.
- Trial name
- NCT03748953
- Testing
- Ixazomib
- Where
- 10 sites in China
- Volunteers
- 37 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Healthy Volunteers
A Study to Assess the Relative Bioavailability and to Assess the Effect of Food on the Bioavailability of a TAK-648 Tablet in Healthy Participants
The purpose of this study is to assess the relative bioavailability of a TAK-648 tablet compared with a TAK-648 oral solution, and to assess the effect of food on the bioavailability of a TAK-648 tablet in healthy participants.
- Trial name
- NCT02480439
- Testing
- TAK-648 Tablet, TAK-648 Oral Solution
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Takeda
Breast Cancer
Study of Oral Vinorelbine Plus Capecitabine Versus Taxane-gemcitabine Combinations as 1st Line Chemotherapy in Metastatic Breast Cancer
The aim of this international open-label randomized phase II trial is to evaluate the efficacy and safety of an all-oral combination and two all-intravenous combinations as first-line therapy for HER2-negative mBC patients.
- Trial name
- NCT03887130
- Testing
- oral vinorelbine, Capecitabine, Gemcitabine 1250 mg/m²
- Volunteers
- 152 people
- Sponsor
- Pierre Fabre Medicament
Breast Neoplasms, Fatigue
A Study to Evaluate the Efficacy and Safety of Orally Administered Extract of Orthosiphon Stamineus (NuvastaticTM-C5OSEW5050ESA) in Patient With Breast Cancer Undergoing Chemotherapy
The goal of this clinical trial is to determine whether Nuvastatic™ can reduce cancer-related fatigue and improve quality of life in adult female patients with breast cancer undergoing standard chemotherapy.
- Conditions
- Breast Neoplasms, Fatigue, Quality of Life, Chemotherapy, Adjuvant
- Trial name
- NuvastaticTM (NCT07669506)
- Testing
- Nuvastatic ™
- Where
- 7 sites in India
- Volunteers
- 180 people
- Sponsor
- Natureceuticals Sdn Bhd
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single and Multiple Oral Dose of TAK-418 in Healthy Female Participants
The purpose of this study is to characterize safety and tolerability of TAK-418 in non-Japanese and Japanese healthy female participants when administered at single or multiple (once daily [QD]) oral doses.
- Trial name
- NCT03501069
- Testing
- TAK-418
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Renal Impairment, Healthy Volunteers
A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys
It is hoped that mobocertinib will eventually help people with cancer with severely reduced kidney function. The main aim of this study is to learn about the levels of mobocertinib in the blood and urine of participants with…
- Trial name
- NCT04056455
- Testing
- Mobocertinib
- Where
- 2 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Epilepsy, Molecular Mechanisms of Pharmalogical Action, Protective Agents
A Phase 1 Positron Emission Tomography Study to Measure Cholesterol 24S-Hydroxylase Target Occupancy of TAK-935
The purpose of this study is to determine the brain cholesterol 24S-hydroxylase (CH24H) enzyme occupancy of TAK-935 after single oral dose in healthy participants using the positron emission tomography (PET) ligand [18F]MNI-792…
- Trial name
- NCT02497235
- Testing
- TAK-935, [18F]MNI-792 (tracer)
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Takeda
Protein Kinase Inhibitors, Antineoplastic Protocols
A Safety and Dose-finding Study of JNJ-26483327, a Drug in Development for Cancer, for Patients With Advanced and/or Refractory Solid Malignancies.
The purpose of this study is to assess JNJ-26483327 (a drug in development for cancer) for the safety of the drug in patients with advanced solid tumors that have not responded or are no longer responding to available therapies.
- Conditions
- Protein Kinase Inhibitors, Antineoplastic Protocols, Clinical Trial, Phase 1, Maximum Tolerated Dose
- Trial name
- NCT00676299
- Testing
- JNJ-26483327
- Volunteers
- 19 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Healthy
Study to Determine D-amino Acid Oxidase Brain Enzyme Occupancy of TAK-831 After Single-dose Oral Administration
The purpose of this study is to determine the relationship between TAK-831 dose, plasma exposure, extent and duration of brain D-amino acid oxidase (DAO) enzyme occupancy following single oral dosing of TAK-831 in healthy…
- Trial name
- NCT02716987
- Testing
- TAK-831, [18F]PGM299
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Neurocrine Biosciences
HIV Infections
A Study of 141W94 in Combination With Other Anti-HIV Drugs
To determine the steady-state pharmacokinetics of 141W94 in combination with saquinavir, indinavir and nelfinavir after multiple oral dosing.
- Trial name
- NCT00002372
- Testing
- Indinavir sulfate, Amprenavir, Nelfinavir mesylate
- Where
- 3 sites in United States
- Volunteers
- 48 people
- Sponsor
- Glaxo Wellcome
Involutional Osteoporosis
A Phase II/III, Double-blind, Parallel Group Comparative Study of Oral Administration of NE-58095 Tablets
The present phase II/III, multicenter, randomized, double-blind, parallel group comparative study is designed to evaluate the efficacy and safety of once-monthly oral administration of NE-58095 delayed release (DR) tablets for 12…
- Trial name
- NCT02063854
- Testing
- NE-58095 IR, NE-58095 DR
- Where
- 25 sites in Japan
- Volunteers
- 871 people
- Sponsor
- Takeda
Carcinoma, Non-Small-Cell Lung
LUME-Lung 1: BIBF 1120 Plus Docetaxel as Compared to Placebo Plus Docetaxel in 2nd Line Non Small Cell Lung Cancer
The present trial will be performed to evaluate whether BIBF 1120 in combination with standard therapy of docetaxel in patients with stage IIIB/IV or recurrent NSCLC is more effective as compared to placebo in combination with…
- Trial name
- NCT00805194
- Testing
- BIBF 1120 plus docetaxel
- Where
- 210 sites in Austria, Belarus and 25 more
- Volunteers
- 1,314 people
- Sponsor
- Boehringer Ingelheim
Gastric Ulcers, Duodenal Ulcers
Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)
The purpose of this study is to evaluate the efficacy of TAK-438, once daily (QD), compared to AG-1749 (Lansoprazole) in patients with a history of gastric or duodenal ulcer who require long-term therapy of non-steroidal…
- Trial name
- NCT01452750
- Testing
- TAK-438, Lansoprazole
- Where
- 102 sites in Japan
- Volunteers
- 642 people
- Sponsor
- Takeda
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics (PK) of Oral TAK-994 in an Acute Sleep Phase Delay Paradigm in Healthy Male Participants
The purpose of this study is to assess the safety and tolerability of TAK-994 and to determine the effect of TAK-994 (compared to placebo) on sleepiness, as measured by mean sleep latency on the maintenance of wakefulness Test…
- Trial name
- NCT04551079
- Testing
- TAK-994
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Takeda
Advanced Nonhematologic Malignancies
A Study MLN2480 in Combination With MLN0128 or Alisertib, or Paclitaxel, or Cetuximab, or Irinotecan in Adult Participants With Advanced Nonhematologic Malignancies
The primary purpose of this study is to determine the safety profile and the maximum tolerated doses (MTDs)/ potential recommended phase 2 doses (RP2Ds) of the combination treatments of MLN2480 + MLN0128, MLN2480 + alisertib…
- Trial name
- NCT02327169
- Testing
- MLN2480, MLN0128, Alisertib
- Where
- 14 sites in United States, France and 2 more
- Volunteers
- 81 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Breast Neoplasms
An Open Label Phase II Trial of BIBW 2992 in Patients With HER2-negative Metastatic Breast Cancer
The purpose of this trial is to evaluate the efficacy, safety and pharmacokinetics of BIBW 2992, a dual, irreversible EGFR- and HER2-inhibitor, in two cohorts of patients with HER2-negative breast cancer after failure of no more…
- Trial name
- NCT00425854
- Testing
- BIBW 2992
- Where
- 14 sites in Belgium, Germany
- Volunteers
- 50 people
- Sponsor
- Boehringer Ingelheim
Advanced Nonhematologic Malignancies
A Safety and Pharmacokinetic Study of TAK-228 in Combination With TAK-117 in Adult Participants With Advanced Nonhematologic Malignancies
The purpose of this study was to evaluate the safety and to determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), and dosing schedules of oral TAK-228+TAK-117.
- Trial name
- NCT01899053
- Testing
- TAK-228, TAK-117
- Where
- 5 sites in United States, Spain and 1 more
- Volunteers
- 101 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Oral Mucositis
RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer
The purpose of this study is to determine if RRx-001, which is added on to the cisplatin and radiation treatment, reduces the incidence of severe oral mucositis in patients with head and neck cancers.
- Trial name
- KEVLARx (NCT05966194)
- Testing
- RRx-001, Intensity Modulated Radiation Therapy (IMRT), Cisplatin for injection 100 mg/m2
- Where
- 14 sites in United States
- Volunteers
- 216 people
- Sponsor
- EpicentRx, Inc.
Prostatic Neoplasms
Oral Treatment With BIBF 1120 Together With Docetaxel and Prednisone in Patients With Hormone Refractory Prostate Cancer
The primary objective of this study was to determine the safety and Maximum tolerated dose (MTD) of BIBF 1120 combination therapy with docetaxel and prednisone in patients with hormone refractory prostate cancer.
- Trial name
- NCT02182219
- Testing
- BIBF 1120
- Volunteers
- 21 people
- Sponsor
- Boehringer Ingelheim
Bioavailability
Bioavailability, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets in Healthy Participants
The purpose of this study is to assess the pharmacokinetics (PK) and Pharmacodynamics (PD) of dexlansoprazole delayed-release orally disintegrating (OD) tablets administered on the tongue and swallowed without water.
- Trial name
- NCT02064907
- Testing
- Dexlansoprazole Delayed Release Orally Disintegrating Tablets, Dexlansoprazole Delayed Release Capsules
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Takeda