FORTIS-M
A Phase 3, randomized, double-blind, placebo-controlled study of oral talactoferrin in addition to best supportive care in patients with non-small cell lung cancer who have failed two or more prior treatment regimens
Principal Investigator: Dr Ross Jennens
Talactoferrin, an orally active immunomodulatory protein, is a new treatment option for non-small cell lung cancer (NSCLC) patients who have already failed two or more prior treatment regimens. Patients with advanced or metastatic NSCLC will be studied using talactoferrin as an alternative treatment to determine the overall survival of participants.
D-CARE
A randomized, double-blind, placebo-controlled, multi-centre phase 3 study of Denosumab as adjuvant treatment for women with early-stage breast cancer at high risk of recurrence (D-CARE).
Principal Investigator: Dr Ross Jennens
Denosumab is an antibody (protein) that might prevent a woman’s breast cancer from getting worse, recurring or spreading to her bones. It is given as an injection under the skin. . Denosumab is a fully human antibody produced from a mammalian cell line by Amgen Inc. Denosumab recognises a protein that is known to be important in the development of bone metastases in cancer called RANK ligand. During the study’s analyses, if denosumab shows a benefit over placebo, the sponsor will offer all women open-label denosumab for the remainder of the study, or until the product is registered for this indication.
Status: Recruiting
Contact: Clinical Trials and Research Centre
MORAb- 003
A Randomized, Double-Blind, Placebo-Controlled, Study of the Safety and Efficacy of Farletuzumab in combination with Carboplatin and Paclitaxel or Docetaxel Followed by Pemetrexed in Chemotherapy-na¿ve Subjects with Stage IV Adenocarcinoma of the Lung with Wild Type EGFR.
Principal Investigator: Dr Ross Jennens
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of farletuzumab in combination with carboplatin and paclitaxel or docetaxel followed by pemetrexed in chemotherapy-naïve subjects with confirmed folate receptor-alpha (FRA)-expressing Stage IV adenocarcinoma of the lung who do not have the EGFR activating mutations, exon 19 del or exon 21 L858R.
Status: Recruiting
Contact: Clinical Trials and Research Centre
MAGRIT
A double-blind, randomized, placebo-controlled Phase III study to assess the efficacy of recMAGE-A3 + AS15 Antigen Specific Cancer Immunotherapeutic as adjuvant therapy in patients with resectable MAGE-A3-positive Non-Small Cell Lung cancer
Principal Investigator: Dr Ross Jennens
Non-small cell lung cancer is the most common type of lung cancer, representing 75-80% of all lung cancer cases. Surgical resection is the cornerstone of therapy for early NSCLC, although relapse is high. However, the MAGE-A3 tumour-specific protein is highly expressed in NSCLC patients and thus is of interest as a potential therapeutic target. The study drug is a recombinant MAGE-A3 antigen combined with the adjuvant AS15 and is anticipated to target MAGE-A3 tumour cells following immunisation to elicit humoral and cellular immune responses. The primary objective of the MAGE-A3 study is to compare disease-free survival (DFS) in NSCLC patients who are MAGE-A3-positive, who have undergone complete surgical resection. Secondary objectives include treatment comparisons with respect to overall survival, lung-cancer-specific survival, DFS at 2, 3, 4 and 5 years after the first study treatment, safety, and immunogenicity.
TyN
A Phase II Open Label Trial of Lapatinib & Vinorelbine in women with Previously Treated HER/2Neu Positive Metastatic Breast Cancer.
Principal Investigator: Dr Rick de Boer
This study plans to evaluate the combination therapy of lapatinib & vinorelbine in patients with
Her2-positive breast cancer who have progressed after initial treatment with Trastuzumab based treatment followed by lapatinib-capecitabine in the metastatic setting. The primary aim of the study is to evaluate the progression-free survival in patients. This will be evaluated using regular tumour scans (CT/MRI and/or Bone scans) to evaluate the response to the study treatment. Scans will be completed 6 weekly until week 24 & then every 12 weeks thereafter.
Status: Recruiting
Contact: Clinical Trials and Research Centre