A Phase II, Multi-center, Randomized, Open-label, Two-arm Study to Assess the Efficacy and Safety of Tenalisib (RP6530), a PI3K δ/γ and SIK3 Inhibitor, in Patients With Locally Advanced or Metastatic Breast Cancer

Rhizen Pharmaceuticals SA3 sites in 1 country40 target enrollmentOctober 13, 2021

ConditionsLocally Advanced Breast Cancer Metastatic Breast Cancer

InterventionsTenalisib 800mg Tenalisib 1200mg

Overview

Phase: Phase 2
Intervention: Tenalisib 800mg
Conditions: Locally Advanced Breast Cancer
Sponsor: Rhizen Pharmaceuticals SA
Enrollment: 40
Locations: 3
Primary Endpoint: Percentage of Patients Without Disease Progression
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Phase II, randomized, open-label study, designed to evaluate the preliminary efficacy and safety of tenalisib at two dose levels in 40 patients with locally advanced or metastatic breast cancer.

Detailed Description

The study will have two groups, Group 1 with a treatment option of 800mg RP6530 BID and Group 2 with a treatment option of 1200mg RP6530 BID, where the subjects will be randomly assigned to each group in 1:1 and continued on each group of treatment till disease progressed.

Registry

clinicaltrials.gov

Start Date

October 13, 2021

End Date

March 31, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Rhizen Pharmaceuticals SA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients must be ≥18 years of age, at the time of signing informed consent.
•Female patients who have histologically and/or cytologically confirmed locally advanced or metastatic breast cancer that has progressed following at least one line of therapy.
•Patients with at least one measurable lesion per RECIST version 1.1 at baseline that can be accurately assessed by CT scan or MRI and is suitable for repeated assessment at follow up-visits.
•ECOG performance status 0 to
•Life expectancy of at least 3 months.
•Adequate bone marrow, liver, and renal functions
•Female patients of childbearing potential should be willing to use a medically acceptable method of contraception

Exclusion Criteria

•Patients with HER-2 positive breast cancer.
•Patients receiving anticancer therapy within 4 weeks or 5 half-lives of the drug prior to C1D1, whichever is shorter.
•Patient who has not recovered from acute toxicities (defined as NCI-CTCAE grade \> 1) of previous therapy except treatment-related alopecia.
•Patients who have had disease progression within 8 weeks of platinum chemotherapy.
•Prior exposure to investigational or marketed PI3K inhibitors given for the treatment of breast cancer.
•Major surgery within 4 weeks of starting study treatment OR any patient who has not recovered from the effects of major surgery.
•Patient with symptomatic uncontrolled brain metastasis.
•HIV-positive patients who are on antiretroviral therapy OR active hepatitis C OR active hepatitis B virus infections.
•Ongoing immunosuppressive therapy including systemic corticosteroids except as allowed per concomitant medication.
•Known history of severe liver injury as judged by the investigator.

Arms & Interventions

Tenalisib 800 mg BID

Single agent at a dose of 800 mg BID

Intervention: Tenalisib 800mg

Tenalisib 1200 mg BID

Single agent at a dose of 1200 mg BID

Intervention: Tenalisib 1200mg

Outcomes

Primary Outcomes

Percentage of Patients Without Disease Progression

Time Frame: Approximately 6 months

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.