How can sponsors and investigators justify the use of an open-label design to regulatory authorities?

Search Clinical Trials ; GOG-3112 (DESTINY-Ovarian01) · A Phase 3, Open-label, Multicenter, Randomized Trial of Trastuzumab Deruxtecan with Bevacizumab Versus ... Oct 2, 2010 ... Methods. We undertook an open-label randomised phase 3 trial in men with metastatic castration-resistant prostate cancer who had received ... Dec 1, 2003 ... ... open-label trial. James Cheng-Chung Wei, Tsai Wen Chan, Huey-Shyan Lin, Feng Huang and Chan-Te Chou. The Journal of Rheumatology December ... This is a first-in-human, Ph 1/2, open-label, multicenter dose escalation and expansion study in advanced solid tumors. A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) compared to ... May 2, 2023 ... A phase II open-label trial of avelumab plus axitinib in previously treated non-small-cell lung cancer or treatment-naïve, cisplatin ... Study #2024-1042. A Phase II multicenter open-label trial of tagraxofusp (Tag) in combination with venetoclax and azacitidine (Ven/Aza) in adults with ... The SEISMIC study was an open-label, prospective, randomised study to assess the safety and feasibility of percutaneous myoblast implantation in heart failure ... A multicenter, single-arm, open-label trial of birociclib, a CDK4/6 inhibitor, as a single agent, in patients with refractory HR+/HER2- metastatic breast ... (143) - Multicenter Open-Label Trial Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetics (PK) of Tacrolimus Inhalational Powder as a Replacement ...