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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Tenalisib will be administered 800mg/ 400mg BID, orally
HCG City Cancer Center
Vijayawada, Andhra Pradesh, India
RECRUITINGNarayana Hrudayala Majumdar Shaw Hospital
Bangalore, Karnataka, India
RECRUITINGTata Memorial Centre
Clinical Benefit Rate (CBR)
It is defined as the percentage of patients achieving complete response (CR), partial response (PR), or stable disease (SD) for 16 weeks or longer.
Time frame: 1 year
Duration of Clinical Benefit (DoCB)
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.
Time frame: 1 year
Overall Response Rate (ORR)
Overall Response is defined as sum of CR and PR.
Time frame: 1 year
Progression Free Survival (PFS)
It is defined as the time from the first dose to disease progression or death on study from any cause, whichever occurs first.
Time frame: 1 year
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0
Number of adverse events reported by the patients
Time frame: 1 year
Trough plasma concentrations of tenalisib/metabolite
plasma concentrations of drug
Time frame: 1 year
Correlation of efficacy to baseline mutational status
Baseline mutational status and its correlation with efficacy
Time frame: 1 year
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Mumbai, Maharashtra, India
Mumbai Oncocare Centre
Mumbai, Maharashtra, India
RECRUITINGSahyadri Super Speciality Hospital
Pune, Maharashtra, India
RECRUITINGNobel Hospital
Pune, Maharashtra, India
RECRUITINGMeenakshi Mission Hospital & Research Center
Madurai, Tamil Nadu, India
NOT_YET_RECRUITINGNizams Institute of Medical Science
Hyderabad, Telangana, India
NOT_YET_RECRUITINGHealth Point Hospital
Kolkata, West Bengal, India
RECRUITING