At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 40 enrolled
Drug / intervention
Tenalisib 800mg +1 moredrug
Likely dose
Tenalisib 800mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Tenalisib 800mg and Tenalisib 1200mg for Locally Advanced Breast Cancer and Metastatic Breast Cancer. Completed, enrolled 40 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGeorgia
Collaborators--
Timeline
Phase 2CompletedFinished
20222023202420252026
First PostedAug 2021
Enrollment StartOct 2021
Primary CompletionMar 2023
TodayJul 2026
First PostedAug 26, 2021
Enrollment StartOct 13, 2021
Primary CompletionMar 31, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 4.9 years ago
Interventions
Tenalisib 800mgdrug
Tenalisib will be administered 800mg BID, orally
Tenalisib 1200mgdrug
Tenalisib will be administered 1200mg BID, orally