Clinical trials: Dose Finding Study
Adult Growth Hormone Deficiency
Versartis International Trial in Adults With Long-Acting Growth Hormone
A Phase 2, open-label dose-finding safety study of individualized monthly VRS-317 dosing for five months in adults with GHD.
- Trial name
- VITAL (NCT02526420)
- Testing
- somavaratan
- Where
- 18 sites in United States, Australia and 2 more
- Volunteers
- 36 people
- Sponsor
- Versartis Inc.
HIV Infections
An Oral Dose-Ranging Finding Study in Patients With HIV Disease, CDC Classification Groups IIB, III, and IV-C2
To establish the relationship between the oral dose of zidovudine (AZT) and its hematologic toxicity. AZT has preliminarily been shown to decrease significant events and death in a group of AIDS / Pneumocystis carinii pneumonia…
- Trial name
- NCT00002023
- Testing
- Zidovudine
- Where
- United States
- Sponsor
- Glaxo Wellcome
Early Breast Cancer
A Dose-Finding Study of Pertuzumab (Perjeta) in Combination With Trastuzumab (Herceptin) in Healthy Male Participants and Women With Early Breast Cancer (EBC)
This study involves a two-part design. Part 1 is designed to determine the optimal dose of subcutaneous (SC) Perjeta, injected alone or mixed with Herceptin, that results in comparable exposure to intravenous (IV) Perjeta.
- Trial name
- NCT02738970
- Testing
- Trastuzumab, Pertuzumab
- Where
- 2 sites in New Zealand
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Vulvovaginal Candidiasis
Arasertaconazole Nitrate Pessaries - Dose Finding Study for the Vulvovaginal Candidiasis (VVC) Treatment
In order to find an optimal dose of arasertaconazole nitrate in the treatment of vulvovaginal candidiasis, a multicenter, randomized, double-blind, parallel, placebo-controlled study will be conducted to compare the therapeutic…
- Trial name
- NCT01144286
- Testing
- arasertaconazole nitrate
- Where
- Spain
- Volunteers
- 229 people
- Sponsor
- Ferrer Internacional S.A.
Hormone Receptor-positive Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer
Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer
The aim of this study is to identify the optimal dose for EP0062 as monotherapy and in combination with standard-of-care therapies to assess its Safety, Tolerability, Pharmacokinetics, and Efficacy in Patients with Relapsed…
- Conditions
- Hormone Receptor-positive Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer
- Trial name
- NCT05573126
- Testing
- EP0062, Elacestrant, Everolimus
- Where
- 14 sites in United States, Spain and 1 more
- Volunteers
- 95 people
- Sponsor
- Ellipses Pharma
Thrombocytopenic Purpura
Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)
The purpose of this study is to assess the safety and tolerability of AMG 531 (romiplostim), a novel thrombopoiesis-stimulating peptibody, and its effect on platelet counts in adults with immune thrombocytopenic purpura.
- Trial name
- NCT00117143
- Testing
- Romiplostim
- Volunteers
- 16 people
- Sponsor
- Amgen
Age-Related Macular Degeneration (AMD), Macular Degeneration
X-82 to Treat Age-related Macular Degeneration
The purpose of this study is to evaluate the safety and efficacy of X-82 in the treatment of vision loss due to wet AMD.
- Conditions
- Age-Related Macular Degeneration (AMD), Macular Degeneration, Exudative Age-related Macular Degeneration, AMD
- Trial name
- NCT02348359
- Testing
- X-82, Anti-VEGF
- Where
- 35 sites in United States
- Volunteers
- 157 people
- Sponsor
- Tyrogenex
Colorectal Cancer, Breast Cancer
Dose-finding Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SNB-101(SN-38) in Patients With Tumors
SNB-101 is a novel nano-particle formulation of SN-38, the active metabolite of irinotecan(CPT-11). Study SNB101P01 is a multicenter, open-label, dose escalation, phase 1 study of SNB 101 with its active ingredient SN-38, in…
- Conditions
- Colorectal Cancer, Breast Cancer, Pancreas Cancer, Ovarian Cancer
- Trial name
- NCT04640480
- Testing
- SNB-101
- Where
- 3 sites in South Korea
- Volunteers
- 21 people
- Sponsor
- SN BioScience
Malignant Melanoma
Study to Assess the Tolerability of a Bispecific Targeted Biologic IMCgp100 in Malignant Melanoma
IMCgp100 is a new biological therapy designed for the treatment of melanoma skin cancer. The drug is designed to target melanoma cells and stimulate immune cells to kill them.
- Trial name
- NCT01211262
- Testing
- IMCgp100
- Where
- 9 sites in United States, United Kingdom
- Volunteers
- 84 people
- Sponsor
- Immunocore Ltd
Acromegaly
ALXN2420 Versus Placebo in Combination With Somatostatin Analogs in Participants With Acromegaly
The primary objective of this study is to evaluate the efficacy of 15-week treatment with ALXN2420 versus placebo for decreasing insulin-like growth factor IGF-1 levels, when administered in combination with somatostatin analog…
- Trial name
- ASTERIA (NCT07037420)
- Testing
- ALXN2420
- Where
- 6 sites in United States, Italy and 2 more
- Volunteers
- 8 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Type 2 Diabetes
GLAD: Dose-Finding, Efficacy, and Safety of AZ 242 (Tesaglitazar) in Subjects With Type 2 Diabetes
This is a 12-week randomized, double-blind, multi-center, active-controlled (open-label pioglitazone) and placebo-controlled study of tesaglitazar (0.1, 0.5, 1, 2, and 3 mg) in patients with type 2 diabetes, not adequately…
- Trial name
- NCT00280865
- Testing
- Tesaglitazar, Pioglitazone, Dietary and Lifestyle Modification Counseling
- Where
- 110 sites in United States, Canada and 2 more
- Volunteers
- 500 people
- Sponsor
- AstraZeneca
Heart Failure, Congestive
A Pilot Study of Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure
This trial is a single center, open-label, dose-finding study of recombinant human relaxin (rhRlx) given intravenously (IV) to patients with stable, compensated CHF.
- Trial name
- NCT00259116
- Testing
- Relaxin
- Where
- Germany
- Volunteers
- 18 people
- Sponsor
- Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
MuSK Myasthenia Gravis
Open-label Study to Evaluate the Safety of Various Dosing Regimens of MuSK-CAART for MuSK Myasthenia Gravis
Muscle-specific tyrosine kinase (MuSK) myasthenia gravis (MG) is a rare but potentially severe disease, in which patients develop pathogenic autoantibodies that specifically target the MuSK protein in the neuromuscular junction.
- Trial name
- NCT05451212
- Testing
- MuSK-CAART
- Where
- 5 sites in United States
- Volunteers
- 7 people
- Sponsor
- Cabaletta Bio
Neoplasms, Breast Neoplasms, Head and Neck Neoplasms
A Study to Evaluate the Potential Benefit of the Addition of BYL719 to Paclitaxel in the Treatment of Breast Cancer and Head-and-neck Cancer
Dose escalation part:to determine the highest dose of BYL719 administered on a daily basis when given in combination with weekly paclitaxel Dose escalation part: to confirm the safety and tolerability of the BYL719 and paclitaxel…
- Trial name
- NCT02051751
- Testing
- BYL719, Paclitaxel
- Where
- 5 sites in United States, France and 2 more
- Volunteers
- 19 people
- Sponsor
- Novartis Pharmaceuticals
Bile Acid Malabsorption
Double-blind, Randomised Study of A3384 in BAM/BAD
The purpose of this trial is to determine the efficacy and safety of A3384 administered to patients with Bile Acid Malabsorption (BAM)/Bile Acid Diarrhoea (BAD).
- Trial name
- NCT02078856
- Testing
- A3384
- Where
- 3 sites in Sweden, United Kingdom
- Volunteers
- 19 people
- Sponsor
- Albireo
Gastric Cancer
Open-label, Dose-finding Study to Determine Antibody Response to G17DT Treatment in Patients With Gastric Cancer.
An open label, dose-finding, schedule-changing, sequential, multiple dose, multi-center study in patients with Stage I-III gastric cancer. The first group of patients received a starting dose of 250 µg at weeks 0, 1, and 3.
- Trial name
- GC3 (NCT02233712)
- Testing
- G17DT
- Volunteers
- 33 people
- Sponsor
- Cancer Advances Inc.
Peripheral T-Cell Lymphoma (PTCL)
A Dose-Finding Study of Folotyn® (Pralatrexate Injection) Plus CHOP With Peripheral T-Cell Lymphoma (PTCL)
The purpose of this study is to evaluate the Maximum Tolerated Dose (MTD) of pralatrexate in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen in patients with newly diagnosed peripheral…
- Trial name
- NCT02594267
- Testing
- Pralatrexate Injection
- Where
- 4 sites in United States
- Volunteers
- 48 people
- Sponsor
- Acrotech Biopharma Inc.
Carcinomatous Edema
A Multicenter, Open-label, Dose-finding Trial of OPC-41061 to Investigate Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety in Patients With Carcinomatous Edema (Phase 2)
OPC-41061 will be administered to patients with volume overload associated with cancer, first by dose-escalation and subsequently for 6 consecutive days at the fixed dose at which urine volume is increased to investigate…
- Trial name
- NCT01684202
- Testing
- OPC-41061
- Where
- Japan
- Volunteers
- 43 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Hyperphosphatemia Patients on Hemodialysis
A Phase 2 Dose-finding Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
A phase 2, randomized, placebo-controlled, double-blind, dose-finding study of TS-172 in hyperphosphatemia patients on hemodialysis
- Trial name
- NCT05699239
- Testing
- TS-172 10mg bid, TS-172 30mg bid, TS-172 60mg bid
- Where
- Japan
- Volunteers
- 326 people
- Sponsor
- Taisho Pharmaceutical Co., Ltd.
OSA - Obstructive Sleep Apnea
Parallel Arm Trial of AD109 and AD504 In Patients With OSA
This is a phase 2 randomized double-blind placebo-controlled parallel-arm dose finding study to compare fixed dose combinations of AD109 and AD504 to atomoxetine or placebo in Obstructive Sleep Apnea.
- Trial name
- MARIPOSA (NCT05071612)
- Testing
- AD109, AD504, Atomoxetine Hydrochloride
- Where
- 25 sites in United States
- Volunteers
- 294 people
- Sponsor
- Apnimed
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