Camsirubicin + Pegfilgrastim to Determine MTD in ASTS
Status:
Recruiting
Trial end date:
2025-06-01
Target enrollment:
Participant gender:
Summary
This is an Interventional Study in Advanced Soft Tissue Sarcomas (ASTS). It is a Phase 1b,
open-label, dose-escalation clinical study evaluating the safety of camsirubicin with
prophylactic pegfilgrastim in the treatment of advanced soft tissue sarcomas. The objective
of the study is to evaluate the safety of camsirubicin with prophylactic pegfilgrastim in the
treatment of ASTS and determine the maximum tolerated dose (MTD) and/or recommended phase 2
dose (RP2D) of camsirubicin with prophylactic pegfilgrastim. The primary endpoint is the MTD
(RP2D).The secondary endpoints are: safety profile of camsirubicin with prophylactic
pegfilgrastim, PFS, TTP, ORR, DoR, OS and PK. As exploratory endpoint, Quality of life will
be measured by using the Functional Assessment of Cancer Therapy: General (FACT-G).