Clinical trials: Neoplasms, Oral
Advanced Malignant Solid Tumors
Safety, Tolerability and Pharmacokinetics Characteristics of Recombinant Oncolytic Vaccinia Virus Injection T601 as a Single Drug or in Combination With Oral Flucytosine (5-FC), in Patients With Advanced Malignant Solid Tumors
This open, dose-escalation and extended PhI/IIa clinical trial aims to evaluate the safety, tolerability of T601 as a single-agent as well as combined with prodrug 5-FC to treat patients with advanced malignant solid tumors and…
- Trial name
- NCT04226066
- Testing
- T601, T601+5-FC
- Where
- 2 sites in China
- Volunteers
- 69 people
- Sponsor
- Tasly Tianjin Biopharmaceutical Co., Ltd.
Breast Cancer, Early Breast Cancer
A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who…
- Trial name
- CAMBRIA-1 (NCT05774951)
- Testing
- Camizestrant, Tamoxifen, Anastrozole
- Where
- 709 sites in United States, Argentina and 37 more
- Volunteers
- 4,300 people
- Sponsor
- AstraZeneca
Head and Neck Cancer
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy
The purpose of this study is to evaluate the efficacy, safety and tolerability of palifermin on the incidence of oral mucositis in subjects with locally advanced head and neck cancer receiving postoperative radiotherapy.
- Trial name
- NCT00540332
- Testing
- palifermin
- Sponsor
- Swedish Orphan Biovitrum
Follicular Lymphoma
SYMPHONY-2, A Trial to Examine Combination of Tazemetostat With Rituximab in Subjects With Relapsed/Refractory Follicular Lymphoma
This study evaluates the safety and efficacy of combining the EZH2 inhibitor tazemetostat with rituximab in R/R FL subjects previously treated with at least 2 standard prior systemic treatment regimens where at least 1…
- Trial name
- NCT04762160
- Testing
- Tazemetostat, Rituximab
- Where
- 20 sites in United States
- Volunteers
- 5 people
- Sponsor
- Epizyme, Inc.
Diffuse Astrocytoma, IDH-Mutant, Glioblastoma, IDH-wildtype
Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis
This multi-site, Phase 1/2 clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO212 alone for the treatment of patients with radiographically-confirmed…
- Conditions
- Diffuse Astrocytoma, IDH-Mutant, Glioblastoma, IDH-wildtype, Brain Metastases, Adult, Cervical Cancer
- Trial name
- NCT06047379
- Testing
- NEO212 Oral Capsule, Ipilimumab, Pembrolizumab
- Where
- 8 sites in United States
- Volunteers
- 134 people
- Sponsor
- Neonc Technologies, Inc.
Cancer
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.
- Trial name
- NCT00538850
- Testing
- Fentanyl sublingual spray
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- INSYS Therapeutics Inc
Oral Mucositis
Safety and Efficacy of IZN-6N4 Oral Rinse for the Prevention of Oral Mucositis in Patients With Head and Neck Cancer
The purpose of this study is to determine whether an oral rinse composed of botanical extracts is effective in the prevention of severe inflammation of the lining of the oral cavity caused by chemotherapy and radiation therapy…
- Trial name
- NCT01400620
- Testing
- IZN-6N4
- Where
- 10 sites in United States, Israel
- Volunteers
- 110 people
- Sponsor
- Izun Pharma Ltd
Gastrointestinal Cancer, Biliary Tract Cancer
Study of D07001-Softgel Capsules in Subjects With Gastrointestinal Cancer in Dose-Escalation Phase and in Subjects With Biliary Tract Cancer in Dose-Expansion Phase
Part 1: Dose-Escalation Phase (Phase 1b) The primary objective is to assess the safety and tolerability of increasing doses of D07001 softgel in patients with unresectable locally advanced or metastatic gastrointestinal (GI)…
- Trial name
- NCT03531320
- Testing
- D07001-softgel capsules
- Where
- 4 sites in Taiwan
- Volunteers
- 19 people
- Sponsor
- InnoPharmax Inc.
Breast Cancer
FIH Study of RGT-419B Alone and With Endocrine Therapy in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer
This is a phase I, First-in-Human (FIH), open-label study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of RGT-419B administered orally as monotherapy OR in combination with Hormonal…
- Trial name
- NCT05304962
- Testing
- RGT-419B, RGT-419B in combination with hormonal therapy
- Where
- 8 sites in United States
- Volunteers
- 64 people
- Sponsor
- Regor Pharmaceuticals Inc.
Triple Negative Breast Cancer
Phase I/II, Evaluate the Safety and Efficacy of BLEX 404 With Docetaxel in Patients With Advanced/Metastatic Triple Negative Breast Cancer.
The primary purpose of this study is to determine the safety and recommended dose level (RDL) of BLEX 404 Oral Liquid combined with Docetaxel monotherapy in a 21-day schedule.
- Trial name
- NCT02802423
- Testing
- BLEX 404 Oral Liquid
- Volunteers
- 44 people
- Sponsor
- BioLite, Inc.
Colorectal Cancer
A Monocentric Study to Investigate a New Low Dose Oral Gut Cleansing Solution
A first study at one centre, with a new oral gut cleansing solution, NRL994, in patients who were going to have a colonoscopy. The study was to find out how well the new "Low Dose Bowel Prep" (LDBP) worked, and whether it was…
- Trial name
- NCT06597903
- Testing
- NRL994
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Norgine
Pain
A Pharmacokinetic and Safety Study of Osmotic Release Oral System (OROS) Hydromorphone in Non-Opioid Tolerant Chinese Participants With Cancer
The purpose of this study is to assess the single dose pharmacokinetic profile (explores what a drug does to the body) and safety of Osmotic Release Oral System (OROS) hydromorphone in chinese participants with cancer (abnormal…
- Trial name
- NCT01824524
- Testing
- Hydromorphone
- Where
- 2 sites in China
- Volunteers
- 12 people
- Sponsor
- Xian-Janssen Pharmaceutical Ltd.
Healthy Volunteers Pharmacokinetic Study
Dose-escalation Study to Assess Selumetinib Safety, Tolerability and PK
The purpose of the study is to assess the safety, tolerability and PK of selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in healthy male Japanese and non-Japanese Asian volunteers following administration of a single dose.
- Trial name
- NCT01960374
- Testing
- Selumetinib
- Where
- United Kingdom
- Volunteers
- 117 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Neoplasm Malignant
Safety and Pharmacokinetics of SAR245408 Daily Oral in Patients With Solid Tumors
Primary Objective: To confirm safety and tolerability of global recommended phase three dose (RPTD) of SAR245408 tablets when administered on continuous once daily dosing (CDD) in patients with solid tumors.
- Trial name
- NCT01392924
- Testing
- SAR245408
- Where
- 2 sites in Japan
- Volunteers
- 10 people
- Sponsor
- Sanofi
Melanoma, Breast Carcinoma
A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors
This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb20717, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity…
- Conditions
- Melanoma, Breast Carcinoma, Hepatocellular Carcinoma, Urothelial Carcinoma
- Trial name
- DUET-2 (NCT03517488)
- Testing
- XmAb20717
- Where
- 17 sites in United States
- Volunteers
- 150 people
- Sponsor
- Xencor, Inc.
Solid Tumours
To Assess the Effect of Rifampicin on the Pharmacokinetics of Selumetinib in Healthy Male Volunteers
Study to assess the effect of Rifampicin on the pharmacokinetics of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers
- Trial name
- NCT02046850
- Testing
- selumetinib, rifampicin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Relapsed Advanced Lymphomas
A Study Evaluating the Safety and Efficacy of AUR108 in Patients With Relapsed Advanced Lymphomas (ASHA-1)
An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced lymphomas will be done to assess AUR108 safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose.
- Trial name
- ASHA-1 (NCT05984147)
- Testing
- AUR108
- Where
- 27 sites in India
- Volunteers
- 40 people
- Sponsor
- Aurigene Discovery Technologies Limited
Pain
Pharmacokinetics & Safety of Diclofenac Potassium Oral Solution in Ped. Subjects (2-12 Yrs) With Mild-Mod. Acute Pain
As part of the Pediatric Research Equity Act (PREA) commitment, the objectives of the study are to characterize the pharmacokinetic (PK) profile and to determine the safety and tolerability of diclofenac potassium oral solution…
- Trial name
- NCT02287350
- Testing
- diclofenac potassium oral solution
- Where
- 5 sites in United States
- Volunteers
- 51 people
- Sponsor
- Depomed
Non-small Cell Lung Cancer
Multicenter Study of Rociletinib Administered to Patients With Previously Treated Mutant EGFR Non-small Cell Lung Cancer
The purpose of this study is to evaluate the safety and anti-tumor effect of rociletinib. The trial is open-ended, which means patients will continue to take rociletinib until the study doctor determines it is no longer…
- Trial name
- NSCLC (NCT02147990)
- Testing
- Rociletinib
- Where
- 91 sites in United States, Australia and 10 more
- Volunteers
- 318 people
- Sponsor
- Clovis Oncology, Inc.
Neoplasm
Crizotinib (Xalkori) Expanded Access Protocol For The Treatment Of Adult Or Pediatric Patients
This is an open label expanded access protocol for the treatment of up to approximately 40 adult or pediatric (defined as age <18 years) patients with tumors harboring either a chromosomal translocation or activating mutation…
- Trial name
- NCT02473497
- Testing
- Crizotinib
- Where
- 17 sites in United States
- Sponsor
- Pfizer
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