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Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC)
Sponsor: Rhizen Pharmaceuticals SA
Summary
This is a Phase II, open-label, single-arm, study, designed to evaluate the efficacy and safety of tenalisib in patients with metastatic TNBC, who have received at least one but not more than 3 prior therapies in a metastatic setting.
Official title: A Phase II, Multi-center, Single-arm, Open-label Study to Assess the Efficacy and Safety of Tenalisib, a PI3K δ/γ, and SIK3 Inhibitor, in Patients With Metastatic Triple Negative Breast Cancer (TNBC)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-03-04
Completion Date
2027-03-31
Last Updated
2025-12-02
Healthy Volunteers
No
Conditions
Interventions
Tenalisib
Tenalisib will be administered 800mg/ 400mg BID, orally
Locations (9)
HCG City Cancer Center
Vijayawada, Andhra Pradesh, India
Narayana Hrudayala Majumdar Shaw Hospital
Bangalore, Karnataka, India
Tata Memorial Centre
Mumbai, Maharashtra, India
Mumbai Oncocare Centre
Mumbai, Maharashtra, India
Sahyadri Super Speciality Hospital
Pune, Maharashtra, India
Nobel Hospital
Pune, Maharashtra, India
Meenakshi Mission Hospital & Research Center
Madurai, Tamil Nadu, India
Nizams Institute of Medical Science
Hyderabad, Telangana, India
Health Point Hospital
Kolkata, West Bengal, India