APICES acknowledged for its role in CABOMAYOR clinical trial
Older, frail patients with metastatic renal cell carcinoma are often underrepresented in trials. The SOGUG-CABOMAYOR phase II study focuses on this group and evaluates first-line cabozantinib, with APICES acknowledged for supporting key study activities.
APICES acknowledged for its role in CABOMAYOR clinical trial
We are proud to announce that APICES has been acknowledged for its ongoing collaboration in the CABOMAYOR Trial, a Phase II clinical trial in metastatic renal cell carcinoma (mRCC). This acknowledgement was highlighted in the Journal ofGeriatric Oncology.
This acknowledgment is a great motivation for the entire APICES team to continue the commitment we bring to every project we collaborate on. We sincerely thank Spanish Oncology Genitourinary Group (SOGUG) and Dr. Miguel Ángel Climent for giving us the opportunity to support the study as CRO and for including us acknowledgments. We also congratulate them and all investigators and patients on the CABOMAYOR trial progress and results.
The CABOMAYOR Trial was aimed at evaluating the efficacy tolerability of anticancer drugs in terms of objective response rate in previously untreated fragile older patients with metastatic renal cell carcinoma (mRCC).
Key Takeaways: First-in-human trials in the EU are governed by Regulation (EU) No 536/2014 and the EMA’s first-in-human guideline (EMEA/CHMP/SWP/28367/07 Rev 1). Sponsors must submit a complete Clinical Trial Application via the CTIS portal and obtain both Part I...
Key Takeaways: Phase I dose escalation design in the EU is governed by ICH E8(R1), EMA first-in-human guidance (EMA/CHMP/SWP/28367/07 Rev.1), and EU Clinical Trial Regulation 536/2014 via CTIS. The classical 3+3 design is increasingly replaced by model-based...
EU MDR clinical investigation requirements have fundamentally changed how Medtech sponsors plan and execute device studies in Europe. Regulation (EU) 2017/745 replaced the clinical investigation provisions of Directive 93/42/EEC (MDD) and introduced a more stringent, harmonised framework across all 27 EU member states. For sponsors running investigations in Spain, Germany, France, the Netherlands, or any other member state, understanding which pathway applies to their study is the single most consequential regulatory decision before CIP submission.