Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT04809805
Eligibility Criteria:
Inclusion Criteria:
Pre-screening:
* Signed informed consent for pre-screening
* Male or female participants aged ≥ 18 years
* Participants with histologically confirmed diagnosis of melanoma, glioblastoma/anaplastic astrocytoma, sarcoma or epithelial ovarian cancer/fallopian tube/primary peritoneal cancer
* Availability of archival tumor tissue (5-10 for prescreening, further 20 to be provided at screening)
* ECOG ≤2
Main Screening :
* Positive SLFN12/PDE3A expression in archival tumour
* Minimum life expectancy at least 12 weeks
* Documented radiological disease progression after treatment with all available standard of care therapies for advanced/metastatic disease and at least one measurable lesion
* Adequate bone marrow, liver, and renal function
* Adequate blood clotting
* Left ventricular ejection fraction \>50%
* All AEs due to previous therapies to CTCAE Grade ≤1. Grade ≤2 neuropathy, fatigue, alopecia, or anorexia, for which further resolution is not expected, may be eligible.
* Negative pregnancy test and use of highly effective contraception
* Signed informed consent for main screening
Exclusion Criteria:
Pre-screening:
* Any malabsorption conditions
* Known HIV infection, active HBV or HCV infection
* Known hypersensitivity to PDE3 inhibitors, or excipients in the formulation; concomitant treatment with any other PDE3 inhibitors
* Participants with clinically relevant cardiovascular diseases and/or relevant ECG findings
* Participants with history of hemorrhage, bleeding disorders or platelet function abnormalities, aneurysm or aneurysmal vasculopathy; Participants with arterial thromboembolic events (ATEs) or venous thromboembolic events (VTEs), including transient ischemic attacks or pulmonary embolism within 6 months before the start of BAY 2666605 or deep vein thrombosis within 3 months before the start of BAY 2666605; Participant with a history of gastrointestinal (GI) ulcerations or perforation, fistula formation involving any internal organs.
Main screening
* Moderate or severe hepatic impairment
* History of organ allograft transplantation, including allogeneic bone marrow
* Previous of co-existing cancer(s) distinct in primary site or histology from the cancer evaluated in this study (with few exceptions)
* Participants with any history of primary meningeal tumors and/or Any active symptomatic or untreated central nervous system (CNS) metastases and/or a number of prior and concomitant therapies
* Major surgery, significant trauma, serious non-healing wound, wound healing complications, ulcer or bone fracture within 4wks prior to 1st dose
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04809805
Study Brief:
Protocol Section:
NCT04809805