Clinical trial • Phase I • Oncology

Clinical trial in Metastatic or locally advanced solid tumors|Lung cancer|Head and neck cancer|Colon cancer|Gastric cancer|Esophageal cancer|Breast cancer|Ovarian cancer|Fallopian tube cancer|Primary peritoneal high-grade serous carcinoma

Phase I trial for Metastatic or locally advanced solid tumors|Lung cancer|Head and neck cancer|Colon cancer|Gastric cancer|Esophageal cancer|Breast cancer…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic or locally advanced solid tumors|Lung cancer|Head and neck cancer|Colon cancer|Gastric cancer|Esophageal cancer|Breast cancer|Ovarian cancer|Fallopian tube cancer|Primary peritoneal high-grade serous carcinoma
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
07-08-2024
First CTIS Authorization Date
09-09-2024

Trial design

Phase I trial across 1 site in Czechia.

Target Sample Size
30

Eligibility

Recruits 30 No vulnerable population selected; no special consent or assent handling described in the record..

Vulnerable Population
No vulnerable population selected; no special consent or assent handling described in the record.

Recruitment

Planned Sample Size
30
Recruitment Window Months
42

Geography

Total Number Of Sites
1
Total Number Of Participants
30

Czechia

Earliest CTIS Part Ii Submission Date
21-02-2024
Latest Decision Or Authorization Date
01-10-2025
Processing Time Days
590
Number Of Sites
1
Number Of Participants
30

Sites

Site Name
Masarykuv Onkologicky Ustav
Department Name
Dptm of Clinical Oncology
Contact Person Name
Radka Lordick Obermannová
Contact Person Email
radka.obermannova@mou.cz

Sponsor

Primary sponsor

Full Name
VUAB Pharma a.s.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Czechia

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