Evaluation of a Promising New Combination of Protein Kinase Inhibitors on Organotypic Cultures of Human Renal Tumors
COMBOREIN
1 other identifier
interventional
100
1 country
1
Brief Summary
The investigators objective is to test the combination directly on organotypic cultures of tumors from patients after their excision in the Department of Urology and Renal Transplantation of the University Hospital of Grenoble and to compare their efficacy with that of currently selected treatments in the clinic. The population targeted by the combination for use in clinical practice is patients with metastatic clear cell renal cell carcinoma. Current treatments for these patients are Sunitinib, Pazopanib and Temsirolimus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 16, 2017
CompletedFirst Submitted
Initial submission to the registry
June 15, 2018
CompletedFirst Posted
Study publicly available on registry
June 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedJanuary 18, 2020
January 1, 2020
5 years
June 15, 2018
January 16, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of cell death on organotypic cultures of human renal tumors (Efficacy)
Death cell rate on organotypic cultures of human renal tumors.
after the treatment period (between 48 and 96 hours)
Study Arms (4)
CK2(CX4945) and ATM(Ku 60019)
EXPERIMENTALTreatment of cell culture with a combination of CK2 and ATM inhibitors serine/ threonin Kinase combination
Sunitinib
ACTIVE COMPARATORTreatment of cell culture with Sunitinib
Pazopanib
ACTIVE COMPARATORTreatment of cell culture with Pazopanib
Temsirolimus
ACTIVE COMPARATORTreatment of cell culture with Temsirolimus
Interventions
Treatment of cell culture with CK2 and ATM inhibitors serine/ threonin Kinase combination
Eligibility Criteria
You may qualify if:
- major patient treated at the University Hospital of Grenoble for a renal tumor with suspected or confirmed malignancy.This includes non-metastatic patients undergoing renal lumpectomy, partial nephrectomy or total nephrectomy, as well as metastatic or locally advanced cancer patients undergoing cytoreductive surgery who are eligible for medical treatment at the same time
You may not qualify if:
- Contaminated patients with HIV and /or HBV (hepatitis B virus) and / or HCV (hepatitis C virus) positive serology.
- Absence or withdrawal of the informed consent of the patient.
- Tumors smaller than 2 cm on preoperative imaging
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Grenoble Alps Hospital
Grenoble, 38043, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2018
First Posted
June 27, 2018
Study Start
October 16, 2017
Primary Completion
September 30, 2022
Study Completion
September 30, 2024
Last Updated
January 18, 2020
Record last verified: 2020-01