Efficacy and Safety of Tenalisib (RP6530), a PI3K δ/γ and SIK3 Inhibitor, in Patients With Locally Advanced or Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05021900
• Other study ID #: RP6530-2101
• Status: Completed
• Phase: Phase 2
• Start date: October 13, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: May 2023
• Source: Rhizen Pharmaceuticals SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients must be =18 years of age, at the time of signing informed consent.

2. 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.

3. 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.

4. ECOG performance status 0 to 2.

5. Life expectancy of at least 3 months.

6. Adequate bone marrow, liver, and renal functions

7. Female patients of childbearing potential should be willing to use a medically acceptable method of contraception

Exclusion Criteria:

1. Patients with HER-2 positive breast cancer.

2. Patients receiving anticancer therapy within 4 weeks or 5 half-lives of the drug prior to C1D1, whichever is shorter.

3. Patient who has not recovered from acute toxicities (defined as NCI-CTCAE grade > 1) of previous therapy except treatment-related alopecia.

4. Patients who have had disease progression within 8 weeks of platinum chemotherapy.

5. Prior exposure to investigational or marketed PI3K inhibitors given for the treatment of breast cancer.

6. Major surgery within 4 weeks of starting study treatment OR any patient who has not recovered from the effects of major surgery.

7. Patient with symptomatic uncontrolled brain metastasis.

8. HIV-positive patients who are on antiretroviral therapy OR active hepatitis C OR active hepatitis B virus infections.

9. Ongoing immunosuppressive therapy including systemic corticosteroids except as allowed per concomitant medication.

10. Known history of severe liver injury as judged by the investigator.

11. History of severe cutaneous reactions in the past.

12. Active gastrointestinal tract disease with malabsorption syndrome or uncontrolled inflammatory gastrointestinal disease such as Crohn's disease or ulcerative colitis.

13. Pregnancy or lactation.

14. Patient with other active malignancies at the time of screening.

Related Conditions & MeSH terms

• Breast Neoplasms
• Locally Advanced Breast Cancer
• Metastatic Breast Cancer

Intervention

Drug:
• Tenalisib
Tenalisib will be administered 800mg BID, orally
• Tenalisib
Tenalisib will be administered 1200mg BID, orally

Locations

Country	Name	City	State
Georgia	High Technology Hospital Medcenter	Batumi
Georgia	LLC Caucasus Medical Center	Tbilisi
Georgia	Simon Khechinashvili University Hospital	Tbilisi

Sponsors (1)

Lead Sponsor	Collaborator
Rhizen Pharmaceuticals SA

Country where clinical trial is conducted

Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients without disease progression		6 months
Secondary	Overall Response Rate (ORR)	It is defined as sum of CR and PR rates	2 years
Secondary	Clinical Benefit Rate (CBR)	It is defined as sum of CR, PR and SD rates	2 years
Secondary	Progression Free Survival (PFS).	PFS is measured from the time of first dose of study drug to radiographic documentation of disease progression or death due to any cause.	2 years
Secondary	Treatment emergent adverse events (TEAEs)		2 years