Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tenalisib.
- Who it may be relevant to
- Registry conditions: Triple Negative Breast Cancer (TNBC). Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Interventions
- Drug Tenalisib
Tenalisib will be administered 800mg/ 400mg BID, orally
Primary outcome measures
- Clinical Benefit Rate (CBR) [Time frame: 1 year]
- Duration of Clinical Benefit (DoCB) [Time frame: 1 year]
- Overall Response Rate (ORR) [Time frame: 1 year]
- Progression Free Survival (PFS) [Time frame: 1 year]
Secondary outcome measures (3)
- Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0 [Time frame: 1 year]
- Trough plasma concentrations of tenalisib/metabolite [Time frame: 1 year]
- Correlation of efficacy to baseline mutational status [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Patients who have histologically confirmed TNBC.
- Patients who have received at least 1 but not more than 3 prior chemotherapy regimens in a metastatic setting.
- Patients with at least one measurable lesion, per RECIST version 1.1 at baseline . Bone-only disease is not permitted.
- ECOG performance status 0 to 2.
- Adequate bone marrow, liver, and renal function
Exclusion criteria
- Cancer therapy/ any cancer investigational drug within 3 weeks (21 days) or 5 half-lives (whichever is shorter).
- Patient who has not recovered from acute toxicities of previous therapy except treatment-related alopecia.
- Prior exposure to PI3K inhibitors (e.g., alpelisib, buparlisib) for breast cancer.
- Major surgery within 4 weeks of starting study treatment.
- Patient with symptomatic uncontrolled brain metastasis.
- Ongoing immunosuppressive therapy including systemic corticosteroids.
- History of severe cutaneous reactions.
- Concurrent disease or condition that would interfere with study participation
- Pregnancy or lactation.
- Any severe and/or uncontrolled medical conditions or other conditions that could affect patient participation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
India · 9 centers
- HCG City Cancer Center — Vijayawada
- Narayana Hrudayala Majumdar Shaw Hospital — Bangalore
- Tata Memorial Centre — Mumbai
- Mumbai Oncocare Centre — Mumbai
- Sahyadri Super Speciality Hospital — Pune
- Nobel Hospital — Pune
- Meenakshi Mission Hospital & Research Center — Madurai
- Nizams Institute of Medical Science — Hyderabad
- … and 1 more center
Identifiers
NCT: NCT06189209 · RP6530-2301