Clinical trials: Dose Finding Study
Crohn Disease
A Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease
The purpose of this study to examine the safety and efficacy of OPC-6535 and determine its optimal dose by once-daily oral administration at 0, 25, or 50 mg for 8 weeks in combination with a fixed oral dose of 5-aminosalicylic…
- Trial name
- NCT00317369
- Testing
- OPC-6535(Tetomilast)
- Where
- 8 sites in Japan
- Volunteers
- 29 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Parkinson Disease, Movement Disorders
Dyskinesia in Parkinson's Disease (Study P04501)
The purpose of the study is to assess the efficacy and safety of a range of doses of SCH 420814 (preladenant) when used together with a stable dose of L-dopa/dopa decarboxylase inhibitor to treat Parkinson's disease.
- Conditions
- Parkinson Disease, Movement Disorders, Central Nervous System Diseases, Neurodegenerative Diseases
- Trial name
- NCT00406029
- Testing
- Preladenant, L-dopa, Other Parkinson's Disease treatments
- Volunteers
- 253 people
- Sponsor
- Merck Sharp & Dohme LLC
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
A Study of CC-90002 in Subjects With Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome (MDS)
Study CC-90002-AML-001 is an open-label, Phase 1 dose escalation (Part A) and expansion (Part B), clinical study of CC-90002, administered by intravenous (IV) infusion, in subjects with relapsed and/or primary refractory AML and…
- Trial name
- NCT02641002
- Testing
- CC-90002
- Where
- 6 sites in United States
- Volunteers
- 28 people
- Sponsor
- Celgene
Locally Recurrent and Metastatic Breast Cancer
Phase1b to Evaluate Safety of AMG706 in Combination With Paclitaxel or Docetaxel for Breast Cancer
This open-label, dose-finding, multi-center study is designed to determine the safety and the maximum tolerated dose of AMG 706 given once daily in combination with either weekly paclitaxel (Arm A) or once-every-3 week docetaxel…
- Trial name
- NCT00322400
- Testing
- Docetaxel, Paclitaxel, AMG 706
- Volunteers
- 46 people
- Sponsor
- Amgen
Chemotherapy-induced Neutropenia
Randomized Phase 2, Dose-finding Efficacy, Safety Study of ANF-RHO™ Versus Neulasta® in Chemotherapy-Induced Neutropenia
Randomized, Open-Label study to determine the dose, efficacy, safety and pharmacokinetic profile of ANF-RHO™ with once-per-cycle injection in comparison with Neulasta in Breast Cancer patients at high risk of developing…
- Trial name
- NCT03559387
- Testing
- ANF-RHO™, Neulasta®
- Where
- 8 sites in France, Netherlands
- Volunteers
- 9 people
- Sponsor
- Prolong Pharmaceuticals
Assisted Reproduction
Identify Effective Doses of LY01021 in Controlled Ovarian Hyperstimulation (COH) for Female Subjects Undergoing Assisted Reproductive Technology (ART)
This is a multicentre, open-label, dose-finding, phase 2 study that will recruit approximately 90 female subjects undergoing COH for in vitro fertilization (IVF) or intracytoplasmic single sperm injection (ICSI).
- Trial name
- NCT07236476
- Testing
- LY01021
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Luye Pharma Group Ltd.
Asthma
Dose Finding Study for QAW039 in Asthma
This study aims to demonstrate a clinically significant improvement in Forced Expiratory Volume in one second (FEV1) in moderate to severe allergic asthmatics inadequately controlled by Inhaled Corticosteroid (ICS) therapy.
- Trial name
- NCT01437735
- Testing
- QAW039, Montelukast
- Where
- 206 sites in United States, Argentina and 20 more
- Volunteers
- 1,043 people
- Sponsor
- Novartis Pharmaceuticals
Gastrointestinal Neoplasms, Cholangiocarcinoma
A Study to Find a Safe and Effective Dose of BI 905711 in Patients With Advanced Gastrointestinal Cancer
Phase 1a - Explore safety and establish the maximum tolerated dose (MTD)/recommended dose levels for phase Ib expansion phase of BI 905711 based on the frequency of patients experiencing dose limiting toxicities (DLTs) during the…
- Conditions
- Gastrointestinal Neoplasms, Cholangiocarcinoma, Pancreatic Neoplasms
- Trial name
- NCT04137289
- Testing
- BI 905711
- Where
- 18 sites in United States, Belgium and 6 more
- Volunteers
- 110 people
- Sponsor
- Boehringer Ingelheim
Non Small Cell Lung Cancer, Pancreatic Cancer
Study of Covalent Menin Inhibitor BMF-219 in Adult Patients With KRAS Driven Non-Small Cell Lung Cancer, Pancreatic Cancer, and Colorectal Cancer
A Phase 1/1b dose finding study to determine the OBD(s) and RP2D(s) of BMF-219, a covalent menin inhibitor small molecule, in subjects with KRAS mutated unresectable, locally advanced, or metastatic NSCLC (Cohort 1), PDAC (Cohort…
- Conditions
- Non Small Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer, NSCLC
- Trial name
- NCT05631574
- Testing
- BMF-219
- Where
- 23 sites in United States, South Korea
- Volunteers
- 13 people
- Sponsor
- Biomea Fusion Inc.
Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
Nilotinib and LDE225 in the Treatment of Chronic or Accelerated Phase Myeloid Leukemia in Patients Who Developed Resistance to Prior Therapy
The purpose of this study is to determine the feasibility of administering the combination of nilotinib and LDE225 to patients with chronic or accelerated phase of chronic myeloid leukemia and to establish the maximum tolerated…
- Trial name
- NCT01456676
- Testing
- Nilotinib + LDE225
- Where
- 7 sites in Canada, France and 3 more
- Volunteers
- 11 people
- Sponsor
- Novartis Pharmaceuticals
Herpes Zoster, Neuralgia
NGX-4010 for the Treatment of Postherpetic Neuralgia
The purpose of the study is determine if an investigational drug, NGX-4010 (high-concentration capsaicin dermal patches) is effective in treating pain associated with post-herpetic neuralgia (PHN).
- Conditions
- Herpes Zoster, Neuralgia, Pain, Peripheral Nervous System Diseases
- Trial name
- NCT00061776
- Testing
- Capsaicin Dermal Patch
- Where
- 28 sites in United States
- Volunteers
- 300 people
- Sponsor
- NeurogesX
Migraine
A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Treatment of Migraine
This is a double-blind, randomized, multicenter, outpatient evaluation of the safety and efficacy of elismetrep as compared to placebo in the acute treatment of migraine.
- Trial name
- NCT06848075
- Testing
- Elismetrep (K-304) 2 mg, Elismetrep (K-304) 5 mg, Elismetrep (K-304) 10 mg
- Where
- 66 sites in United States
- Volunteers
- 431 people
- Sponsor
- TriGemX Bio, Inc.
Parkinson's Disease
A Dose Finding Study of Preladenant (SCH 420814) for the Treatment of Parkinson's Disease (PD) in Japanese Patients (P06402)
This study is to evaluate the efficacy of a range of preladenant doses compared with placebo in participants with moderate to severe Parkinson's disease (PD) experiencing motor fluctuations and receiving a stable dose of levodopa…
- Trial name
- NCT01294800
- Testing
- Preladenant
- Volunteers
- 450 people
- Sponsor
- Merck Sharp & Dohme LLC
Non-small Cell Lung Cancer, Melanoma
IMM60 and Pembrolizumab in Melanoma and NSCLC
The goal of this clinical trial is to learn about IMM60 with or without pembrolizumab in participants with advanced melanoma or non-small cell lung cancer.
- Trial name
- NCT05709821
- Testing
- IMM60, Pembrolizumab
- Where
- 14 sites in United States, Spain and 1 more
- Volunteers
- 1 people
- Sponsor
- iOx Therapeutics
Detection of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 in Individuals Exposed to SARS-CoV-2
Assessment of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens
This dose finding, multi-cohort study is designed to evaluate the safety and efficacy of intradermally-injectedTNX-2100, synthesized SARS-CoV-2 peptide antigens and assess the presence and magnitude of DTH reactions.
- Trial name
- COVID-19 DTH (NCT05216510)
- Testing
- TNX-2110, TNX-2120, TNX-2130
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Tonix Pharmaceuticals, Inc.
Adult Growth Hormone Deficiency
MOD-4023 (Long-Lasting Human Growth Hormone (hGH)) Study in Growth Hormone Deficient Adults (GHDA)
This study aims to assess the safety, tolerability and Pharmacokinetics/ Pharmacodynamics (PK/PD) profile of three doses of MOD-4023 on a weekly regime and one dose on an every-other-week regime administered for a period of 4…
- Trial name
- NCT01225666
- Testing
- MOD-4023
- Where
- 15 sites in Czechia, Hungary and 4 more
- Volunteers
- 52 people
- Sponsor
- OPKO Health, Inc.
Metastatic Breast Cancer, Stage IV Breast Cancer
Dose-finding Study of BP-C1 in Patients With Stage IV Breast Cancer
The purpose of this study is to estimate the cumulative Maximum Tolerated Dose (MTD) and Minimum Efficient Dose (MED) of BP-C1 in the short-term treatment of metastatic breast cancer patients.
- Trial name
- NCT04298333
- Testing
- BP-C1
- Where
- 3 sites in Indonesia, Taiwan and 1 more
- Volunteers
- 18 people
- Sponsor
- Meabco A/S
Malignant Disease
Safety of MP470 in Combination With Standard-of-Care Chemotherapy Regimens to Treat Solid Tumors
Adult subjects with malignant disease appropriate for treatment with carboplatin/paclitaxel, carboplatin/etoposide, topotecan, docetaxel or erlotinib according to the standard dosing regimen will be enrolled in each treatment…
- Trial name
- SGI-0470-02 (NCT00881166)
- Testing
- MP-470 + topotecan, MP-470 + docetaxel, MP-470 + erlotinib
- Where
- 5 sites in United States
- Volunteers
- 101 people
- Sponsor
- Astex Pharmaceuticals, Inc.
Neoplasms
A Study to Test BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) and BI 765179 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Cancer
This study is open to adults with advanced cancer (solid tumors) and people with advanced head and neck cancer. The study has 2 parts.
- Trial name
- NCT04958239
- Testing
- BI 765179, Ezabenlimab, Pembrolizumab
- Where
- 48 sites in United States, Australia and 13 more
- Volunteers
- 151 people
- Sponsor
- Boehringer Ingelheim
Recurrent Extensive Stage Small Cell Lung Carcinoma
HTMC0435 and Temozolomide in Treating Patients With Small Cell Lung Cancer
The Phase 1b part of this clinical trial is to investigate the safety and pharmacokinetic (PK) characteristics of HTMC0435 tablets combined with temozolomide in patients with various advanced solid tumors (recurrent small cell…
- Trial name
- NCT05728619
- Testing
- HTMC0435, Temozolomide
- Where
- 3 sites in China
- Volunteers
- 64 people
- Sponsor
- Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
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