Clinical Trials in India / NCT06189209
Recruiting
Phase 2
Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC)
NCT06189209 · tracked via the Priya Life Science India tracker
Condition(s) studied
Triple Negative Breast Cancer (TNBC)
Investigational drug(s) / intervention(s)
Tenalisib
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
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.
View NCT06189209 on ClinicalTrials.gov ↗ ← All trials in India