A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study Evaluating the Safety and Efficacy of Intravenous Iloprost in Subjects With Systemic Sclerosis Experiencing Symptomatic Digital Ischemic Episodes (AURORA Study)

Date Added
November 12th, 2019
PRO Number
Pro00092860
Researcher
Edwin Smith

List of Studies


Keywords
Autoimmune disease, Drug Studies, Immune System, Rare Diseases, Scleroderma, Stage III
Summary

The purpose of this study is to find out more information about the study drug iloprost for the treatment of symptomatic Raynaud's phenomenon (RP) attacks in people with scleroderma. A Raynaud's attack is defined as one where you notice at least one color change of your finger(s) (blue, white, or red) associated with at least one symptom (pain, numbness, tingling, and/or discomfort of the finger[s]). Your participation in this study will last approximately 9 weeks and will include 8 visits to the study center and 1 phone call from the study staff.

Institution
MUSC
Recruitment Contact
Brittany Frasier
843-792-8613
Frasibri@musc.edu

Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Locoregionally Advanced Head and Neck Cancer with a Contraindication to Cisplatin

Date Added
May 18th, 2018
PRO Number
Pro00077581
Researcher
Anand Sharma

List of Studies


Keywords
Cancer, Cancer/Head & Neck, Stage II, Stage III
Summary

This study is for patients that have been diagnosed with stage III-IVB Head and Neck cancer. The investigational drug in this study is MEDI4736 (Durvalumab). The purpose of the safety lead-in portion of the study is to determine whether adding the study drug MEDI4736 to radiation is safe in patients with head and neck cancer who cannot take the drug cisplatin. The purpose of the phase II/III portion is to compare any good and bad effects of usual radiation plus the study treatment, MEDI4736 (durvalumab), to the usual therapy of radiation plus cetuximab in patients with head and neck cancer who cannot take the drug cisplatin. Participants in the safety lead-in portion can expect to be in this study for approximately 2.5 years. Participants in the Phase II/III portion can expect to be in the study for up to 32 weeks, and then followed by their study doctor to monitor for side effects every year.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu



-- OR --