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

NCT05021900 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-08-13

Study results available
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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.

Conditions

Interventions

DRUG

Tenalisib 800mg

Tenalisib will be administered 800mg BID, orally

DRUG

Tenalisib 1200mg

Tenalisib will be administered 1200mg BID, orally

Sponsors & Collaborators

  • Rhizen Pharmaceuticals SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-13
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • Georgia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05021900 on ClinicalTrials.gov