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Набира участници Фаза 3

Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

Ovarian Cancer

The purpose of this study is to evaluate INCB123667 versus investigator's choice of chemotherapy in participants with platinum-resistant ovarian cancer with cyclin E1 overexpression.

Начало: 09.12.2025 Край: 14.05.2029 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +12 Incyte Corporation NCT07214779

Набира участници Фаза 3

A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)

Chronic Kidney Disease

This study is open to children aged 2 to 17 with chronic kidney disease (CKD). The purpose of this study is to find out if a medicine called empagliflozin helps children and adolescents with CKD. Other goals of the study are to find out how empagliflozin is tolerated and handled by the body in children and adolescents with CKD. Participants are put into 2 groups randomly, which means by chance. One group takes empagliflozin and the other group takes placebo. Placebo looks like empagliflozin but does not contain any medicine. Participants are twice as likely to be in the empagliflozin group. Participants take empagliflozin or placebo as tablets once a day for 6 months. After 6 months, participants in both groups take empagliflozin as tablets once a day for 1 year. Participants are in the study for a little over a year and a half. During this time, they visit the study site about 15 times and get at least 5 phone or video calls from the site staff. At the visits, the doctors take blood and urine samples from the participants. The doctors also regularly check participants' health and take note of any unwanted effects.

Начало: 09.12.2025 Край: 25.06.2029 Възраст: 2–17 г. Лечение

Argentina, Australia, Belgium +14 Boehringer Ingelheim NCT07107945

Набира участници

Investigating the Efficacy of a Paediatric Fertility Preservation Decision Aid in Parents and Adolescents and Young Adults (CAYA) Cancer Survivors

Unmet Fertility Information Needs

The current standard of care for paediatric patients with cancer regarding preservation of their fertility (FP) is to provide high-quality information during the clinical consultation process. However, this approach depends on health provider knowledge and communication and has been shown to be sub-optimal in some situations. This impairs the critical decision-making of patients regarding fertility testing, utilization of gametes, and continuing payment of storage fees. The fertility preservation decision aid (FP DA) may lead to a greater understanding of their fertility status for participants. This knowledge may allow participants the opportunity to assess potential fertility issues prior to the end of their reproductive window, helping to minimize missed opportunities for parenthood. This research study aims to assess the effectiveness of the use of the FP DA on unmet fertility information needs when it is provided in addition to high-quality information in parents of cancer survivors and CAYA cancer survivors compared to high-quality information alone.

Начало: 08.12.2025 Край: 01.07.2026 Възраст: от 16 г. Друго

Australia Murdoch Childrens Research Institute NCT06894810

Набира участници Фаза 1

A Study to Evaluate the Safety, Tolerability and PK of SK-09

FSGS MCD

This Phase 1 trial consists of two parts: Part 1 is a Single Ascending Dose (SAD) study, and Part 2 is a Multiple Ascending Dose (MAD) study. Both parts adopt a randomized, double-blind, placebo-controlled design.

Начало: 08.12.2025 Край: 31.08.2026 Възраст: 18–55 г. Лечение

Australia Consun Pharmaceutical Group NCT07267026

Набира участници Фаза 2

Phase 2 Study of SAT-3247 in Pediatric Ambulatory Patients

Duchenne Muscular Dystrophy Duchenne DMD Neuromuscular Diseases +1

Phase 2a trial of SAT-3247 in ambulatory DMD patients aged ≥ 7 and \< 10 years. The trial will study two doses of SAT-3247 in a randomized, double-blind, placebo-controlled weekday regimen for 12 weeks to determine the optimal dose, safety, tolerability, and preliminary efficacy.

Начало: 08.12.2025 Край: 30.06.2027 Възраст: 7–9 г. Лечение

Australia, Belgium, Canada +5 Satellos Bioscience, Inc. NCT07287189

Набира участници Фаза 2

Novel Treatment of Radiation Associated Dysphagia With Statins

Radiation-associated Dysphagia Head &Amp; Neck Cancer

The aim of this trial is to examine the feasibility, acceptability, and potential efficacy of a 12-month course of pravastatin as an antifibrotic agent for managing dysphagia (swallowing problems) in patients previously treated with radiotherapy for head and neck cancer (HNC). The purpose is to assess whether pravastatin, a medication approved in Australia for cholesterol management, can improve swallowing in people with long-term radiation-associated dysphagia following HNC treatment. The trial will recruit 48 patients, with an anticipated accrual period of approximately 6 months. Eligible patients will be identified from the Principal Investigator's current study, ERADICATE, or through referral by a radiation oncologist or speech pathologist diagnosing radiation-induced dysphagia. Participants will receive 40 mg of pravastatin daily for up to 12 months, with swallowing assessments conducted before, during, and after treatment.

Начало: 05.12.2025 Край: 01.10.2028 Възраст: от 18 г. Лечение

Australia Peter MacCallum Cancer Centre, Australia NCT07217938

Набира участници Фаза 1

Absolute Bioavailability Study of Cizutamig in Healthy Adult Participants

Healthy Participants Study

The purpose of this study is to determine the absolute bioavailability of SC administered cizutamig in healthy adult participants.

Начало: 04.12.2025 Край: 01.03.2026 Възраст: 18–65 г. Лечение

Australia Candid Therapeutics NCT07236411

Набира участници Фаза 4

Pasteurised Donor Human Milk Supplementation for Term Babies

Neonatal Hypoglycemia Metabolic Complication Cows Milk Allergy Hospital Length of Stay +3

PRESENT is a multi-center randomised controlled trial that aims to assess whether access to pasteurized donor human milk as supplementary nutrition in the first five days of life for term infants born to women with diabetes in pregnancy reduces the proportion of infants who are admitted to a neonatal unit for management of hypoglycemia compared with current standard hospital care. The trial will also assess other important outcomes including breastfeeding rates, maternal mental health, and infant cow's milk allergy. There will be two treatment arms. In the intervention arm, PDHM will be made available to infants from randomisation until day 5 of life. Infants allocated to the control arm will receive care as per local unit policy, including supplemental nutrition as recommended by the treating clinician. After hospital discharge, participants will be asked to complete an electronic questionnaire at 2 \& 6 weeks and 6 \& 12 months after birth. Questionnaires will assess infant feeding practices, maternal quality of life \[including anxiety and depression symptoms and health-related quality of life\] along with infant cow's milk allergy symptoms.

Начало: 04.12.2025 Край: 01.12.2028 Възраст: до 48 г. Превенция

Australia The University of Queensland NCT06993103

Набира участници Фаза 2

A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)

Neoplasm Malignant

Researchers want to learn if calderasib given alone or with cetuximab can treat certain advanced solid tumors in people with the KRAS G12C mutation. The goals of this study are to learn: * How many people have the cancer respond (get smaller or go away) to calderasib alone or with cetuximab and how these responses compare * About the safety of calderasib alone or with cetuximab and if people tolerate the treatments.

Начало: 04.12.2025 Край: 09.04.2032 Възраст: от 18 г. Лечение

Australia, China, Denmark +11 Merck Sharp & Dohme LLC NCT07209111

Набира участници Фаза 3

A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)

Biliary Tract Cancer

The purpose of this study is to measure the efficacy and safety of rilvegostomig with gemcitabine plus cisplatin vs. durvalumab with gemcitabine plus cisplatin as first line treatment for patients with advanced BTC.

Начало: 04.12.2025 Край: 04.07.2029 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +16 AstraZeneca NCT07221253

Набира участници Фаза 1/2

A Study to Evaluate Safety and Efficacy of OLX72021 in Healthy Males With Androgenetic Alopecia

Androgenetic Alopecia (AGA)

This study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of OLX72021 in medically healthy men with mild to moderate androgenetic alopecia.

Начало: 04.12.2025 Край: 01.03.2027 Възраст: 18–59 г. Лечение

Australia Olix Pharmaceuticals, Inc. NCT07327359

Набира участници Фаза 3

A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy

Gastrointestinal Neoplasms

The purpose of this study is to find out if a new drug, called IDRX-42 (also known as GSK6042981), is effective in treating adults with a type of cancer called Gastrointestinal Stromal Tumors (GIST) when compared to another drug named sunitinib. The study will see if IDRX-42 works well and is safe for participants whose GIST has spread or cannot be surgically removed, and who have already taken the drug imatinib.

Начало: 03.12.2025 Край: 29.11.2030 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +15 GlaxoSmithKline NCT07218926

Набира участници

Early Versus Late Stopping of Antibiotics in Adults With High-risk Hematological Malignancies/Receiving Cellular Therapies and Fever

Leukemia CART Therapy Transplantation, Stem Cell Infections, Bacterial

Pre-neutropenic fever (PNF) (fever following chemotherapy but before developing low white cells) and neutropenic fever (NF) (fever in the setting of low white cells) are very common after chemotherapy for acute leukemia, bone marrow transplantation or Chimeric Antigen Receptor T-cell (CAR T) therapy. Often, there is no bacterial cause for fever found, and in the setting of a well patient with resolved fever, some studies have shown it to be safe to cease antibiotic therapy which was commenced at the onset of fever. This reduces the overall exposure to antibiotics, which can be beneficial to the patient (reduced risk of resistant bugs emerging, reduced serious side effects). However, some subgroups of high-risk patients have been underrepresented in these studies (in particular, those who have received a bone marrow transplant from a donor, those with longer duration of low white cells) and none have been performed in Australia, hence applying this data to our setting and patient groups is indirect and further data are needed. This study plans to recruit participants who have received chemotherapy for acute leukemia or a stem cell transplant (either their own cells or a donor's cells) or CAR T-cell therapy and perform a trial to compare early stopping of antibiotics (STOP arm) to the standard of care, which traditionally involves continuing antibiotics until the white cell count reaches above a specific threshold. The primary study outcome is duration of days free of antibiotics within 28 days of study allocation. The investigators will also observe for important clinical outcomes including rates of fever recurrence, bloodstream and other infections, intensive care admission and mortality. Patients will stay in hospital during this period, even in the setting of stopping antibiotics, and these antibiotics can be recommenced urgently according to the sepsis protocol if there is concern for infection.

Начало: 03.12.2025 Край: 05.02.2028 Възраст: от 18 г. Лечение

Australia Peter MacCallum Cancer Centre, Australia NCT07051525

Набира участници Фаза 1

A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tumors

Neoplasms

The goal of this clinical trial is to test a new medicine called GSK5764227, which delivers a toxin directly to cancer cells to destroy them while sparing healthy cells. The study will combine GSK5764227 with standard treatments to evaluate its safety, examine how the body processes it, check if it triggers any immune responses, and assess whether it can shrink or control cancer.

Начало: 03.12.2025 Край: 29.09.2028 Възраст: от 18 г. Лечение

Australia, Spain, United States GlaxoSmithKline NCT07277270

Набира участници Фаза 1

Study to Evaluate Safety of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy

Lumbosacral Radicular Pain Sciatic Radiculopathy Sciatic Leg Pain Sciatica +2

The purpose of this study is to evaluate the safety and tolerability of C-1101 administered as a single dose, transforaminal epidural injection compared to sterile saline

Начало: 03.12.2025 Край: 01.12.2026 Възраст: 18–65 г. Лечение

Australia Consano Bio NCT07264270

Набира участници Фаза 3

A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head and Neck Cancer

Squamous Cell Carcinoma of Head and Neck

The purpose of this study is to compare anti-tumor activity of amivantamab in addition to pembrolizumab and carboplatin versus pembrolizumab, 5-fluorouracil (FU), and platinum therapy (carboplatin or cisplatin) in participants with refractory/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). HNSCC is a type of cancer that develops in the head and neck regions, including the outer tissue layer of the mouth and throat. This study will focus on participants with HNSCC who are treatment-naive (have not received prior treatment) in the R/M setting.

Начало: 03.12.2025 Край: 18.06.2029 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +16 Janssen Research & Development, LLC NCT07276399

Набира участници Фаза 1/2

Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Healthy Adults With and Without Androgenetic Alopecia

Androgenetic Alopecia (AGA) Healthy Volunteers - Male and Female

The goal of this clinical trial is to learn if ABS-201 (a new medication) is safe and tolerable when used to improve hair growth in men and women. The trial will start with healthy volunteers and if safe, will treat participants with certain types of hair loss. The main questions it aims to answer are: What medical problems, if any, do participants experience when taking a single dose or many doses of ABS-201? How does the medication, ABS-201, compare to placebo (a look alike substance that does not contain any medication). Participants who qualify for the trial will receive either ABS-201 or a placebo, and visit the study clinic for scheduled checkups and tests for approximately 1 year.

Начало: 03.12.2025 Край: 01.07.2028 Възраст: 18–65 г. Лечение

Australia Absci Pty Ltd. NCT07317544

Набира участници Фаза 1

A Phase 1 Study of CLYM116 in Normal Healthy Volunteers

Healthy Volunteers

This Phase 1, first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CLYM116 in healthy volunteers.

Начало: 02.12.2025 Край: 01.09.2026 Възраст: 18–60 г. Фундаментална наука

Australia Climb Bio, Inc. NCT07248865

Набира участници Фаза 1

Study Evaluating Safety, Tolerability, PK/PD of Surovatamig in Adult RA or SLE Participants

Rheumatoid Arthritis Systemic Lupus Erythematosus

This open-label, Phase I study will assess the safety and tolerability of surovatamig and characterise its PK and PD following subcutaneous administration to participants with RA or SLE.

Начало: 02.12.2025 Край: 27.06.2028 Възраст: 18–65 г. Лечение

Australia, Belgium, Brazil +6 AstraZeneca NCT07201558

Набира участници

Treponemal Shedding, Load, and Viability, in Women and Men-who-have-sex-with-women-only With Early Infectious Syphilis: Implications for Transmission

Syphilis

How syphilis is transmitted between sexual partners is unclear. Asymptomatic detection i.e. detection of syphilis bacteria (Tp) from anatomical sites without lesions, in patients with syphilis infection, suggests that asymptomatic transmission from these sites may play a role. However, no existing studies have established whether the syphilis bacteria (Tp) detected was viable. This means it is not known if the bacteria at this anatomical site is alive and therefore able to transmit the infection. Further, studies have focused mostly on men who have sex with men, resulting in a lack of evidence regarding anal shedding in men-who-have-sex-with-women only and women (regardless of sexual behaviour), and no data on asymptomatic vaginal shedding in women. This study will explore: 1. Patterns of Tp detection in women and men-who-have-sex-with-women only. 2. Whether detected Tp from each asymptomatic anatomical sites is viable 3. Duration of Tp detection and viability (alive and transmissible bacteria). Patients presenting to a participating sexual health service (overseas only) for management of suspected/confirmed early infectious syphilis will be eligible. During the routine clinical examination, participants will have additional oral and anal swabs, urine, vaginal swab (where relevant), penile skin swab (where relevant) and blood sample collected, in addition to the routine samples taken from the same sites and routine serology collected when syphilis is diagnosed.

Начало: 02.12.2025 Край: 31.12.2028 Възраст: от 18 г.

Australia, China, South Africa +1 Monash University NCT07300254

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