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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

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