Status:
TERMINATED
A Study to Learn How Safe BAY2666605 is, How it Affects the Body, How it Moves Into, Through and Out of the Body, the Maximum Amount That Can be Given and Its Action Against Tumors in Adult Participants With Skin Cancer That Has Spread to Other Parts of the Body and Other Types of Advanced Cancer
Lead Sponsor:
Bayer
Conditions:
Metastatic Melanoma and Other Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Researchers are looking for a better way to treat people who have advanced cancer. In this study researchers want to learn more about a new substance called BAY2666605. BAY2666605 triggers the format...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2023
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04809805
Start Date
April 15 2021
End Date
April 27 2023
Last Update
December 14 2023
Active Locations (3)
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1
Sarah Cannon Development Innovations
Nashville, Tennessee, United States, 37203
2
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
3
South Texas Accelerated Research Therapeutics | START San Antonio
San Antonio, Texas, United States, 78229-3307