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โ† Trials
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Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC)

RecruitingPhase 2Ages 18 Years - anyFemaleRhizen Pharmaceuticals SA
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Tenalisib
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Where

9 sites
HCG City Cancer Center
Vijayawada, India
Narayana Hrudayala Majumdar Shaw Hospital
Bangalore, India
Tata Memorial Centre
Mumbai, India
Mumbai Oncocare Centre
Mumbai, India
Sahyadri Super Speciality Hospital
Pune, India
Nobel Hospital
Pune, India
Meenakshi Mission Hospital & Research Center
Madurai, India
Nizams Institute of Medical Science
Hyderabad, India

โ€ฆand 1 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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