NCT05021900

Efficacy and Safety of Tenalisib (RP6530), in Patients With Locally Advanced or Metastatic Breast Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Rhizen Pharmaceuticals SA · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locally Advanced Breast Cancer
• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Tenalisib 800mg	Tenalisib will be administered 800mg BID, orally
DRUG	Tenalisib 1200mg	Tenalisib will be administered 1200mg BID, orally

Timeline

• Start date: 2021-10-13
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2021-08-26
• Last updated: 2024-08-13
• Results posted: 2024-08-13

Locations

3 sites across 1 country: Georgia