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  • Phase 1/2 Study of IMC-R117C in Selected Advanced Cancers

    Phase

    1/2

    Span

    203 weeks

    Sponsor

    Immunocore Ltd

    Melbourne

    Recruiting

  • A New Website for Australian IVF Patients: 'Evidence-based IVF'

    In response to widespread calls for evidence-based resources about IVF options and add-ons in Australia, the investigators assembled a multidisciplinary team to co-design a novel website prototype referred to as 'Evidence-based IVF (EBI)'. Informed by patient decision aids standards, the MAGIC App, and applying the investigators' expertise in digital and risk communication and evidence-informed health decisions, the investigators undertook interviews with Australian IVF patients and professionals to test and iteratively modify a new resource. This trial will evaluate how this website performs in terms of gist knowledge and acceptability.

    Phase

    N/A

    Span

    11 weeks

    Sponsor

    University of Melbourne

    Melbourne, Victoria

    Recruiting

  • A Multiple Ascending Dose Study of DT-216P2 in Patients With Friedreich's Ataxia

    Phase

    1/2

    Span

    96 weeks

    Sponsor

    Design Therapeutics, Inc.

    Melbourne, Victoria

    Recruiting

  • A Phase 2 Study of PTX 100 in Patients With Relapsed/Refractory CTCL

    PTX-100 from a Phase I study shown to help some CTCL patients. This Phase II study will be conducted in a larger population size and there will be initially two groups/arms in the first phase called Phase 2a. This phase will randomize and enroll 20 subjects into the 500 mg/m2 and 20 subjects into the 1000 mg/m2 PTX treatment arms. After determining the recommended optimal dose from phase 2a, for Phase 2b, 75 subjects will then be allocated into this single arm part of the study. Once subject has signed the informed consent, subject will undergo a 28 day screening period, where eligibility would be determined. Once subject is eligible, subject will be dosed with IP. Safety bloods will be taken on the first day of every cycle. Pharmacokinetics (PKs) which are blood samples sent to the Sponsors associated laboratory and will be analysed on how PTX-100 interacts biologically. PKs will be taken on Cycle1Day1(C1D1) to C1D5 and C1D8 for the first 4 cycles. Subject will also undergo skin evaluation and safety exams at every Cycle Day 1. Subjects will also complete quality of life questionnaires at every Cycle Day1. Subjects will be on the study for 18months, until disease progression, unacceptable toxicity, participant or Investigator decision, or until study treatment discontinuation criteria are met, whichever occurs first.

    Phase

    2

    Span

    170 weeks

    Sponsor

    Prescient Therapeutics, Ltd.

    Melbourne, Victoria

    Recruiting

  • The Dragon PLC Trial (DRAGON-PLC)

    Primary liver cancer (PLC) is the third most common cause of cancer death worldwide. Surgical resection is the mainstay for a curative approach as contemporary chemotherapy and immune-based therapies only lead to a median survival of 10-14 months. A complete surgical resection increases the median survival to 42 months (range 32-52 months). However, PLC is mainly diagnosed at an advanced stage and >70% of PLC patients are ineligible for an immediate surgical approach. There are different reasons that make a patient ineligible for surgery, one important reason is the risk of liver failure after the surgery due to a small remnant liver. This study aims to improve the oncological, radiological and surgical strategy to allow more patients to undergo liver resection safely, to improve quality of life and to extend overall survival at acceptable costs. Adequate function of the future liver remnant (FLR) is a prerequisite for surgical resectability. This is necessary in order to avoid liver failure after surgery, a major cause of morbidity (38%) and mortality (27%). To mitigate this risk, regenerative strategies based on preoperative calculation of the FLR volume and function are essential. Patients with technically resectable disease but predicted insufficient FLR volume or function are referred to as primarily unresectable or potentially resectable (PU/PR). These patients can undergo strategies that capitalize on the regenerative capacity of the liver which aim to preoperatively increase the FLR volume and function in order to allow surgery. Many of the patients that are primarily unresectable due to an insufficient FLR can become ultimately and safely resectable after the induction of adequate FLR-hypertrophy by the current standard, portal vein embolisation (PVE). However, 25% of patients do not show sufficient FLR growth after PVE and are unable to safely undergo resection. A new approach has been developed to improve this. Combined portal and hepatic vein embolisation (PVE/HVE) has great promise in terms of increasing FLR growth, resection rate (RR), safety and potentially, overall survival. Establishing PVE/HVE as the new standard could result in increased survival and a better quality of life (QoL) for patients.

    Phase

    N/A

    Span

    398 weeks

    Sponsor

    Maastricht University

    Melbourne

    Recruiting

  • A Study to Evaluate MWN109 Injection in Healthy Subjects

    A total of 72 healthy volunteers are expected to be enrolled into this study. Study consists of 2 parts- Part A- Single Ascending dose (SAD) and part B- Multiple ascending dose (MAD). The entire study duration per participant is estimated to be a maximum of 8 weeks for the single ascending dose (SAD) part and 12 weeks for the multiple ascending dose (MAD) part. The end of study is defined as the date of the last visit of the last participant in the study.

    Phase

    1

    Span

    37 weeks

    Sponsor

    Shanghai Minwei Biotechnology Co., Ltd

    Melbourne, Victoria

    Recruiting

    Healthy Volunteers

  • 89Zr-olaratumab Dosimetry in Participants With Soft Tissue Sarcoma

    Platelet-derived growth factor receptor α (PDGFRα) is expressed on soft tissue sarcoma (STS) where it could act as a potential therapeutic target. Olaratumab is a PDGFRα-targeted antibody that has the potential to act as the targeting moiety for both imaging and therapeutic radioisotopes. Olaratumab's demonstrated safety profile and its ability to target PDGFRα on STS cell surfaces and be rapidly internalised, make it a promising candidate for use as a radionuclide targeting agent in STS. 89Zr-TLX300-CDx is being developed for PDGFRα molecular imaging with positron emission tomography (PET) in STS. The aim of this study is to provide proof-of-concept tumour targeting of 89Zr-TLX300-CDx and assess the safety and radiation dosimetry of radiolabelled olaratumab. This study will inform future development of olaratumab as a therapeutic radiopharmaceutical agent in STS. SCHEDULE OF ASSESSMENTS Part A and B: IMAGING: 1 single injection of 89Zr-TLX300-CDx on Day 1 and whole-body imaging at 6 days ± 1 day post-injection Blood Collection for PHARMACOKINETICS: Pre-injection, 4h ± 0.5h and 6 days ± 1 day post-injection. OPTIONAL: Imaging at 4h ± 0.5h post-injection. Part C: IMAGING: 1 single injection of 89Zr-TLX300-CDx on Day 1, whole-body imaging at 24h ± 4h post-injection, whole-body imaging at 4 days ± 1 post-injection and whole-body imaging at 7 days ± 1 day post-injection Blood collection for PHARMACOKINECTCS: Pre-injection, 4h ± 0.5h, 24h ± 4h, 4 days ± 1 day and 7 days ± 1 day post-injection. OPTIONAL: Dynamic imaging 15 min ± 2 min post-injection at selected sites (extended field-of-view scanner is available), imaging at 4h ± 0.5h post-injection and imaging at 7h ± 1hpost-injection

    Phase

    1

    Span

    96 weeks

    Sponsor

    Telix Pharmaceuticals (Innovations) Pty Ltd

    Melbourne, Victoria

    Recruiting

  • The Purpose of the Study is to Evaluate the Safety, Tolerability and Pharmacokinetics of Single-ascending and Multiple-ascending Doses of GIM-407

    Phase

    1

    Span

    30 weeks

    Sponsor

    Georgiamune Inc

    Melbourne, Victoria

    Recruiting

    Healthy Volunteers

  • A Study to Evaluate S227928 as a Single Agent and in Combination With Venetoclax in Patients With R/R AML, MDS/AML, or CMML

    Phase

    1/2

    Span

    287 weeks

    Sponsor

    Servier Bio-Innovation LLC

    Melbourne

    Recruiting

  • Evaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitive Prostate Cancer

    Phase

    1

    Span

    235 weeks

    Sponsor

    Amgen

    Melbourne, Victoria

    Recruiting

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