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Активно (без набиране) Фаза 3

Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL

Chronic Lymphocytic Leukemia

This Primary objective is evaluating the efficacy of obinutuzumab in combination with chlorambucil (Arm A) compared with acalabrutinib in combination with obinutuzumab (Arm B) for the treatment of previously untreated chronic lymphocytic leukemia (CLL). Secondary objectives: 1) To evaluate the efficacy of obinutuzumab in combination with chlorambucil (Arm A) versus acalabrutinib monotherapy (Arm C) based on IRC assessment of PFS per IWCLL 2008 criteria. 2)To compare obinutuzumab plus chlorambucil (Arm A) versus acalabrutinib plus obinutuzumab (Arm B) and obinutuzumab plus chlorambucil (Arm A) versus acalabrutinib monotherapy (Arm C) in terms of: IRC-assessed objective response rate (ORR); Tine to next treatment (TTNT); Overall Survival (OS)

Начало: 26.06.2015 Край: 30.09.2025 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +15 Acerta Pharma BV NCT02475681

Активно (без набиране) Фаза 1

Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer

ALK-positive NSCLC

This is an open label multi center trial to determine the safety and efficacy of ceritinib in combination with nivolumab in ALK-positive NSCLC patients

Начало: 27.05.2015 Край: 09.04.2027 Възраст: 18–100 г. Лечение

Australia, Belgium, Canada +5 Novartis Pharmaceuticals NCT02393625

Активно (без набиране)

Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System

Mitral Valve Insufficiency

PILOT: The study is a pilot trial to evaluate the safety and performance of the Twelve TMVR System in high risk mitral regurgitation patients. EFS: The study is an Early Feasibility Study to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with moderate-Severe or severe, Symptomatic Mitral Regurgitation

Начало: 01.04.2015 Край: 01.12.2028 Възраст: от 18 г. Лечение

Australia, Denmark, Finland +4 Medtronic Cardiovascular NCT02322840

Активно (без набиране) Фаза 1

A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations

Advanced Malignancies That Harbor IDHR132 Mutations

A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132 mutations.

Начало: 06.03.2015 Край: 31.10.2030 Възраст: 18–100 г. Лечение

Australia, Belgium, Canada +5 Novartis Pharmaceuticals NCT02381886

Активно (без набиране) Фаза 4

CINC424A2X01B Rollover Protocol

Primary Myelofibrosis Polycythemia Vera Graft Versus Host Disease Acute Myeloid Leukemia +1

This is a long term safety study for patients that have been treated with either ruxolitinib or a combination of ruxolitinib with panobinostat, on a Novartis or Incyte sponsored study, who have been judged by the study Investigator to benefit from ongoing treatment.

Начало: 05.03.2015 Край: 16.09.2027 Възраст: 1–100 г. Лечение

Australia, Belgium, Bulgaria +21 Novartis Pharmaceuticals NCT02386800

Активно (без набиране) Фаза 2

An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma

Mantle Cell Lymphoma (MCL)

The purpose of this study is to characterize the safety and efficacy profile of ACP-196 (acalabrutinib) in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL).

Начало: 02.03.2015 Край: 09.09.2026 Възраст: от 18 г. Лечение

Australia, Belgium, Czechia +7 Acerta Pharma BV NCT02213926

Активно (без набиране) Фаза 4

A Study of Two Different Doses of Cabozantinib (XL184) in Progressive, Metastatic Medullary Thyroid Cancer

Medullary Thyroid Cancer

The objective of this study is to evaluate the efficacy and safety of oral cabozantinib at a 60 mg dose compared with a 140 mg dose in subjects with progressive, metastatic MTC. It will test if the lower dose results in similar progression free survival (PFS) and overall response rate (ORR) with fewer adverse events compared to the PFS, ORR and adverse events found in previous clinical trials of 140 mg.

Начало: 25.02.2015 Край: 01.01.2035 Възраст: от 18 г. Лечение

Australia, Canada, Croatia +11 Exelixis NCT01896479

Активно (без набиране) Фаза 3

Double Blind Placebo Controlled Controlled Study of Adjuvant MEDI4736 In Completely Resected NSCLC

Non-Small Cell Lung Cancer

The purpose of this study is to find out whether it is better to receive a new drug, MEDI4736, or better to receive no further treatment after surgery (and possibly chemotherapy) for lung cancer.

Начало: 24.02.2015 Край: 31.01.2026 Възраст: от 18 г. Лечение

Australia, Brazil, Bulgaria +16 Canadian Cancer Trials Group NCT02273375

Активно (без набиране) Фаза 3

Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients

HIV Infections

The purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068) is effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug resistance.

Начало: 23.02.2015 Край: 30.09.2026 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +21 ViiV Healthcare NCT02362503

Активно (без набиране)

MelmarT Melanoma Margins Trial Investigating 1cm v 2cm Wide Excision Margins for Primary Cutaneous Melanoma

Cutaneous Melanoma by AJCC V7 Stage

Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with a primary invasive cutaneous melanomas \>=1mm thick to determine differences in the rate of local recurrence and melanoma specific survival. A reduction in margins is expected to improve quality of life in patients

Начало: 03.01.2015 Край: 05.08.2026 Възраст: от 18 г. Лечение

Australia, Canada, Sweden +2 Melanoma and Skin Cancer Trials Limited NCT02385214

Активно (без набиране)

Compass - Randomised Controlled Trial of Primary HPV Testing for Cervical Screening in Australia

Cancer of the Cervix Cervical Intraepithelial Neoplasia

Compass is a randomised controlled trial of primary HPV testing for cervical cancer screening in Australia. A pilot study involving 5,000 women was carried out in 2013-2014. The trial will involve recruiting 76,300 women from primary health clinics. Women aged 25-69, attending for cervical screening or for routine follow-up will be invited to participate in the 2-arm trial. A liquid-based cytology (LBC) sample will be taken from consenting women and sent to VCS Pathology. Women will be randomised in a 1:2 parallel group allocation to LBC and HPV arms using randomisation with the minimisation procedure, with stratification by birth cohort according to whether offered HPV vaccination in Australia's national publicly-funded HPV vaccination program (date of birth \>=July 1st 1980 and \

Начало: 01.01.2015 Край: 01.03.2037 Възраст: 25–69 г. Скрининг

Australia VCS Foundation NCT02328872

Активно (без набиране) Фаза 3

Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia

Recurrent B Acute Lymphoblastic Leukemia

This randomized phase III trial studies how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Immunotherapy with blinatumomab may allow the body's immune system to attack and destroy some types of leukemia cells. It is not yet known whether blinatumomab is more effective than standard combination chemotherapy in treating relapsed B-cell acute lymphoblastic leukemia.

Начало: 17.12.2014 Край: 16.09.2026 Възраст: 1–31 г. Лечение

Australia, Canada, New Zealand +2 National Cancer Institute (NCI) NCT02101853

Активно (без набиране) Фаза 3

Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)

Hormone Sensitive Prostate Cancer Prostate Cancer Cancer of the Prostate

The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both. The randomized / blinded portion of the study is now completed following primary endpoint analyses. The study remains ongoing in open label format.

Начало: 17.12.2014 Край: 19.09.2026 Възраст: от 18 г. Лечение

Australia, Brazil, Canada +13 Pfizer NCT02319837

Активно (без набиране)

Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer

Early Breast Cancer

The best available evidence suggests that pregnancy after breast cancer does not increase a woman's risk of developing a recurrence from her breast cancer. In particular, the most recent data suggest that this is the case also in women with a hormone receptor-positive breast cancer. There is also no indication of increased risk for delivery complications or for the newborn. The aim of the study is to investigate if temporary interruption of endocrine therapy, with the goal to permit pregnancy, is associated with a higher risk of breast cancer recurrence.The study aims also to evaluate different specific indicators related to fertility, pregnancy and breast cancer biology in young women. A psycho-oncological companion study on fertility concerns, psychological well-being and decisional conflicts will be conducted in interested Centers.

Начало: 04.12.2014 Край: 01.12.2028 Възраст: 18–42 г. Лечение

Australia, Belgium, Canada +18 ETOP IBCSG Partners Foundation NCT02308085

Активно (без набиране) Фаза 4

Can Vitamin D Supplementation in the First Year of Life Prevent Food Allergy in Infants? The VITALITY Trial: Parts 1&2

Food Allergy

We report that Australia has the highest prevalence of Immunoglobulin(Ig)E-mediated food allergy in the world, with 10% of infants having challenge-proven food allergy in Melbourne. There has been a 5-fold increase in hospital admissions for life-threatening anaphylaxis. These changes are most pronounced in children less than 5 years, suggesting a causal role for early life determinants. We have primary data to inform hypotheses for the rise in food allergy, which appears to result from potentially modifiable factors related to the modern lifestyle, particularly Vitamin D insufficiency (VDI). We propose an intervention study to assess if infant Vitamin D supplementation during the first year of life significantly decreases the risk of early-onset food allergy and other allergic disease at 12 months (part 1) and 6 years of age (part 2). Australia is ideally placed to answer this important question since, unlike the USA, Canada and Europe, there are no population recommendations for routine infant supplementation with Vitamin D and we are one of the few developed countries that do not supplement the food chain supply with Vitamin D.

Начало: 01.12.2014 Край: 01.12.2028 Възраст: 6–12 г. Превенция

Australia Murdoch Childrens Research Institute NCT02112734

Активно (без набиране) Фаза 3

An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)

Prostatic Neoplasms

The purpose of this study is to compare the radiographic progression-free survival (rPFS) of apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any chemotherapy \[treatment of cancer using drugs\]) metastatic castration-resistant prostate cancer (mCRPC) (cancer of prostate gland \[gland that makes fluid that aids movement of sperm\]).

Начало: 26.11.2014 Край: 31.12.2027 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +13 Aragon Pharmaceuticals, Inc. NCT02257736

Активно (без набиране) Фаза 3

A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer

Breast Cancer

The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio.

Начало: 06.11.2014 Край: 01.12.2026 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +18 Eli Lilly and Company NCT02246621

Активно (без набиране) Фаза 2

Anti-PD 1 Brain Collaboration for Patients With Melanoma Brain Metastases

Melanoma Brain Metastases

The purpose of this research project is to test the effectiveness of nivolumab versus nivolumab together with ipilimumab for the treatment of melanoma brain metastases. Patients are eligible to join this study if they are aged 18 years or above and have been diagnosed with melanoma with brain metastases.

Начало: 04.11.2014 Край: 01.12.2028 Възраст: от 18 г. Лечение

Australia Melanoma Institute Australia NCT02374242

Активно (без набиране) Фаза 3

Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma

Adult T Acute Lymphoblastic Leukemia Ann Arbor Stage II Adult Lymphoblastic Lymphoma Ann Arbor Stage II Childhood Lymphoblastic Lymphoma Ann Arbor Stage III Adult Lymphoblastic Lymphoma +4

This randomized phase III trial compares how well combination chemotherapy works when given with or without bortezomib in treating patients with newly diagnosed T-cell acute lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma. Bortezomib may help reduce the number of leukemia or lymphoma cells by blocking some of the enzymes needed for cell growth. It may also help chemotherapy work better by making cancer cells more sensitive to the drugs. It is not yet known if giving standard chemotherapy with or without bortezomib is more effective in treating newly diagnosed T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.

Начало: 04.10.2014 Край: 16.09.2026 Възраст: 1–30 г. Лечение

Australia, Canada, New Zealand +1 National Cancer Institute (NCI) NCT02112916

Активно (без набиране) Фаза 2

Neoadjuvant Dabrafenib + Trametinib for AJCC Stage IIIB-C BRAF V600 Mutation Positive Melanoma

Melanoma

This is an open label, single centre, phase II study of neoadjuvant drug treatment with dabrafenib + trametinib in patients with resectable American Joint Committee on Cancer (AJCC) Stage IIIB-C BRAF V600 mutation positive melanoma. The main aim of this study is to find out if giving of a new combined drug treatment to patients with melanoma that has spread to the lymph nodes BEFORE they have surgery, will result in improved clinical and pathological response of the melanoma tissue after 12 weeks treatment.

Начало: 01.10.2014 Край: 01.05.2026 Възраст: от 18 г. Лечение

Australia Melanoma Institute Australia NCT01972347

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