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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04056247
Other study ID # OH-HRPP-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date October 1, 2029

Study information

Verified date August 2023
Source OncoHost Ltd.
Contact Shani Raveh Shoval, Ph.D.
Phone 97248537554
Email shani@oncohost.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will develop an algorithm of identifying patients with stage IV NSCLC and Melanoma who could benefit from cancer treatment they receive.


Description:

The goal of this research study is to develop an algorithm that predicts the patient's treatment outcome.This algorithm will serve as a tool for physicians when making treatment decisions, specifically for stage IV NSCLC and malignant melanoma patients receiving anti-cancer treatments. The investigators also aim to identify the metabolic pathways that could lead to better therapeutic options. The patients will be given their treatment according to the institute's standard of care. The patients will provide two blood samples and clinical data will be collected from their medical records. In the first part of the trial, the data obtained from the blood samples and the medical records of the patients will be used to develop the prediction algorithm, and in the second part of the trial, the algorithm will be validated by comparing the objective response rate of the patients to the theoretical response prediction of the algorithm.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date October 1, 2029
Est. primary completion date October 1, 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Cancer patients with stage IV NSCLC or stage IV malignant melanoma - Patient must have at least one measurable lesion and the relevant images in order to enable assessment of response - ECOG PS - 0/1-2 - Normal hematologic, renal and liver function: 1. Absolute neutrophil count higher than 1500/mm3 2. Platelets count higher than 100,000/mm3 3. haemoglobin higher than 9 g/dL 4. Creatinine concentration =1.4 mg/dL, or creatinine clearance higher than 40 mL/min 5. Total bilirubin lower than 1.5 mg/dL, ALT and AST levels = 3 times above the upper normal limit. Exclusion Criteria: - Concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug - Generalized impairment or mental incompetence that would render the patient unable to understand his/her participation in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Plasma sample collection
Collect at least two plasma samples

Locations

Country Name City State
Germany Asklepois Gauting
Germany Thoraxklinik Heidelberg gGmbH Heidelberg
Israel Haemek Medical Center Afula
Israel Barzilai Medical Center Ashkelon
Israel Soroka Medical Center Be'er Sheva
Israel Shamir Medical Center Be'er Ya'aqov
Israel Bnai Zion Medical Center Haifa
Israel Rambam Medical Center Haifa
Israel Hadassah Medcial Center Jerusalem
Israel Meir medical center Kfar Saba
Israel Rabin Medical Center Petah tikva
Israel Kaplan Medical Center Re?ovot
Israel Assuta Medical Cetner Tel Aviv
Israel Sheba Medical Center Tel Aviv
Israel Sourasky Medical Center Tel Aviv
Israel Sheba medical center Tel HaShomer
Spain 044 Hospital Universitario Virgen Macarena Seville
United Kingdom Aberdeen Royal Infirmary Aberdeen
United Kingdom Royal Bournemouth General Hospital Bournemouth
United Kingdom Bradford Teaching Hospitals Bradford
United Kingdom Cheltenham General Hospital Cheltenham
United Kingdom Withybush Hospital Haverfordwest
United Kingdom Mount Vernon Cancer Centre Northwood
United Kingdom The Shrewsbury and Telford Hospital Shrewsbury
United Kingdom South Tyneside South Shields
United Kingdom Lister Hospital Stevenage
United Kingdom Sunderland Royal Hospital Sunderland
United Kingdom Swansea Bay UHB Singleton Hospital Swansea
United Kingdom Torbay Hospital Torquay
United States Birmingham VAHCS Birmingham Alabama
United States Roswell Park Buffalo New York
United States Helen Nassif Community Cancer Center Cedar Rapids Iowa
United States West Clinic Germantown Tennessee
United States Michael E. Debakey VA Medical Center Houston Texas
United States Mayo Clinic Jacksonville Florida
United States University of Miami Miami Florida
United States Rutgers Cancer Institute New Brunswick New Jersey
United States Florida Cancer Specialist and Research Institute Orlando Florida
United States Protean Biodiagnosics Orlando Florida
United States Northwest Community Healthcare Rolling Meadows Illinois
United States 151-Christus Health St. Michael Texarkana Texas

Sponsors (1)

Lead Sponsor Collaborator
OncoHost Ltd.

Countries where clinical trial is conducted

United States,  Germany,  Israel,  Spain,  United Kingdom, 

References & Publications (3)

Shaked Y, Bocci G, Munoz R, Man S, Ebos JM, Hicklin DJ, Bertolini F, D'Amato R, Kerbel RS. Cellular and molecular surrogate markers to monitor targeted and non-targeted antiangiogenic drug activity and determine optimal biologic dose. Curr Cancer Drug Targets. 2005 Nov;5(7):551-9. doi: 10.2174/156800905774574020. — View Citation

Shaked Y, Kerbel RS. Antiangiogenic strategies on defense: on the possibility of blocking rebounds by the tumor vasculature after chemotherapy. Cancer Res. 2007 Aug 1;67(15):7055-8. doi: 10.1158/0008-5472.CAN-07-0905. — View Citation

Shaked Y. Balancing efficacy of and host immune responses to cancer therapy: the yin and yang effects. Nat Rev Clin Oncol. 2016 Oct;13(10):611-26. doi: 10.1038/nrclinonc.2016.57. Epub 2016 Apr 26. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Adverse Events (AE) AE, as reported by the patients At second blood collection, 3 months and 6 months after treatment and EOS (2 years)
Other Progression Free Survival (PFS) Collect Progression Free Survival (PFS) dates At End of study (2 years)
Other Overall Survival (OS) Collect Overall Survival (OS) dates At End of study (2 years)
Other Duration of Response (DOR) Collect Duration of Response (DOR) dates At End of study (2 years)
Primary Overall response rate (ORR) at 3 months ORR as defined by RECIST 1.1 or other validated method for ORR evaluation At 3 months after therapy
Primary Overall response rate (ORR) at 6 months ORR as defined by RECIST 1.1 or other validated method for ORR evaluation At 6 months after therapy
Primary Changes in the blood levels of different proteins that represent the host response Changes in Blood levels of proteins representing the Host response At baseline (pre-therapy) and after 1st dose administration (post therapy)
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