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Trial Title:
Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC)
NCT ID:
NCT06189209
Condition:
Triple Negative Breast Cancer (TNBC)
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Tenalisib
Conditions: Keywords:
RP6530
Tenalisib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tenalisib
Description:
Tenalisib will be administered 800mg BID, orally
Arm group label:
Single arm, Open label study
Other name:
RP6530
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
HCG City Cancer Center
Address:
City:
Vijayawada
Zip:
520002
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr. Priyadarshini Lakshmi
Facility:
Name:
Narayana Hrudayala Majumdar Shaw Hospital
Address:
City:
Bangalore
Zip:
560099
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr Pragnya Coca
Facility:
Name:
Tata Memorial Centre
Address:
City:
Mumbai
Zip:
400012
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr. Sudeep Gupta
Facility:
Name:
Mumbai Oncocare Centre
Address:
City:
Mumbai
Zip:
400056
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr. Ashish Joshi
Facility:
Name:
Sahyadri Super Speciality Hospital
Address:
City:
Pune
Zip:
411004
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr. Tushar Patil
Facility:
Name:
Meenakshi Mission Hospital & Research Center
Address:
City:
Madurai
Zip:
625107
Country:
India
Status:
Not yet recruiting
Contact:
Last name:
Dr. Saju SV
Facility:
Name:
Nizams Institute of Medical Science
Address:
City:
Hyderabad
Zip:
500082
Country:
India
Status:
Not yet recruiting
Contact:
Last name:
Dr. Sadashivudu Gundeti
Start date:
March 4, 2024
Completion date:
March 2025
Lead sponsor:
Agency:
Rhizen Pharmaceuticals SA
Agency class:
Industry
Collaborator:
Agency:
Incozen Therapeutics Pvt Ltd
Agency class:
Other
Source:
Rhizen Pharmaceuticals SA
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06189209
