Cancer
01 Jan 2013
Post-Operative Concurrent Chemo-Radiotherapy Versus Post-Operative Radiotherapy for Cancer of the Head and Neck
The primary objective of the trial is to determine, in patients who have undergone surgery with curative intent for high-risk cutaneous squamous cell carcinoma (CSCC) of the head and neck, whether there is a difference in time to loco-regional relapse between patients treated with post-operative concurrent chemo-radiotherapy ,consisting of Carboplatin,…
Cancer
01 Jan 2013
Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Cutaneous Squamous Cell Carcinoma In Situ
The purpose of this study is to determine whether the topical application of PEP005 is safe and effective for the treatment of cutaneous squamous cell carcinoma in situ (SCCIS, Bowen’s disease). Official Title Multi-Centre, Open-Label Study to Determine the Safety and Efficacy of PEP005 0.05% Topical Gel in Patients With…
Cancer
01 Jan 2013
Metvix PDT in Patients With “High Risk” Basal Cell Carcinoma
The variable “complete response” after one or two Metvix treatment cycles will be used as the basis for the justification of sample size. The following hypothesis will be tested: H0: Complete response rate of Metvix is less or equal to 65% versus the alternative hypothesis HA: Complete response rate…
Cancer
01 Jan 2013
Study to Compare the Efficacy and Safety of CC-5013 Vs. Placebo in Subjects With Metastatic Malignant Melanoma.
Subjects are randomized to one of two treatment arms. All subjects are screened for eligibility within 28 days prior to randomization. The study consists of a treatment phase and a follow-up phase. Subjects are treated in repeating 4 week cycles. Official Title Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Compare the…
Cancer
01 Jan 2013
A Study of LY573636 in Treating Patients With Malignant Melanoma
The primary objective of this study is to determine the objective response rate (complete and partial response) for patients who receive LY573636 after one prior systemic treatment for unresectable or metastatic melanoma. Official Title A Phase 2 Study of LY573636 Administered as an Intravenous Infusion on Day 1 of a…
Cancer
01 Jan 2013
Vaccine Therapy for Patients With Stage III Melanoma
This is a Phase 3 study in patients with melanoma that has spread to the lymph nodes (stage III), and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the ‘CancerVax’ vaccine to prevent or slow the recurrence of…
Research and Trials
01 Jan 2013
Isavuconazole in the Treatment of Candidemia and Other Invasive Candida Infections
The purpose of the study is to compare the safety and efficacy of Isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive Candida infections. Official Title A Phase III, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of Isavuconazole Versus Caspofungin Followed by Voriconazole…
Lungs
01 Jan 2013
Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study
The purpose of this study is to determine the efficacy and safety of chronic treatment with inhaled dry powder mannitol in subjects with cystic fibrosis. We also hypothesize that enhanced mucociliary clearance will result in a sustained reduction in mucus load, thus providing less opportunity for bacteria to proliferate, affording…
Infections
01 Jan 2013
Safety Study of Oral BTA9881 to Treat Respiratory Syncytial Virus Infections
This is a placebo-controlled, double-blind, randomised, single dose escalation Phase I clinical trial to determine the safety and tolerability of BTA9881 administered orally to healthy subjects. Official Title A Phase I, Single-Centre, Double-Blind, Placebo-Controlled, Escalating Single Oral Dose, Safety and Tolerability Clinical Trial With BTA9881 in Healthy Subjects Conditions…