Tenalisib: Tenalisib will be administered 800mg/ 400mg BID, orally
Study 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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Patients who have histologically confirmed TNBC.
2. Patients who have received at least 1 but not more than 3 prior chemotherapy regimens in a metastatic setting.
3. Patients with at least one measurable lesion, per RECIST version 1.1 at baseline . Bone-only disease is not permitted.
4. ECOG performance status 0 to 2.
5. Adequate bone marrow, liver, and renal function
Exclusion Criteria:
1. Cancer therapy/ any cancer investigational drug within 3 weeks (21 days) or 5 half-lives (whichever is shorter).
2. Patient who has not recovered from acute toxicities of previous therapy except treatment-related alopecia.
3. Prior exposure to PI3K inhibitors (e.g., alpelisib, buparlisib) for breast cancer.
4. Major surgery within 4 weeks of starting study treatment.
5. Patient with symptomatic uncontrolled brain metastasis.
6. Ongoing immunosuppressive therapy including systemic corticosteroids.
7. History of severe cutaneous reactions.
8. Concurrent disease or condition that would interfere with study participation
9. Pregnancy or lactation.
10. Any severe and/or uncontrolled medical conditions or other conditions that could affect patient participation
Primary outcome measure(s)
Clinical Benefit Rate (CBR) — 1 year It is defined as the percentage of patients achieving complete response (CR), partial response (PR), or stable disease (SD) for 16 weeks or longer.
Duration of Clinical Benefit (DoCB) — 1 year It is defined as the time from the first dose to disease progression or death on study from any cause, whichever occurs first in patients who achieve CR, PR or SD for 16 weeks or longer.
Overall Response Rate (ORR) — 1 year Overall Response is defined as sum of CR and PR.
Progression Free Survival (PFS) — 1 year It is defined as the time from the first dose to disease progression or death on study from any cause, whichever occurs first.
Trial sites (9)
Facility
City
Region
Status
HCG City Cancer Center
Vijayawada
Andhra Pradesh
Recruiting
Narayana Hrudayala Majumdar Shaw Hospital
Bangalore
Karnataka
Recruiting
Tata Memorial Centre
Mumbai
Maharashtra
Recruiting
Mumbai Oncocare Centre
Mumbai
Maharashtra
Recruiting
Sahyadri Super Speciality Hospital
Pune
Maharashtra
Recruiting
Nobel Hospital
Pune
Maharashtra
Recruiting
Meenakshi Mission Hospital & Research Center
Madurai
Tamil Nadu
Not Yet Recruiting
Nizams Institute of Medical Science
Hyderabad
Telangana
Not Yet Recruiting
Health Point Hospital
Kolkata
West Bengal
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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