RecruitingPhase 1Phase 2NCT05035745

Selinexor & Talazoparib in Advanced Refractory Solid Tumors; Advanced/Metastatic Triple Negative Breast Cancer (START)

Phase I Dose Finding Study of Selinexor and Talazoparib in Patients With Advanced Refractory Solid Tumors, Followed by Phase II Expansion Cohort Study in Patients With Advanced/ Metastatic Triple Negative Breast Cancers. (START)


Sponsor

National University Hospital, Singapore

Enrollment

63 participants

Start Date

Mar 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single arm, open-label, phase I dose finding study, followed by a phase II expansion study. Phase I will be carried out in a modified 3+3 dose escalation design, with a projected enrolment of 33 patients with refractory solid tumors to determine the RP2D. In the phase II portion, a total of 30 patients with advanced/metastatic TNBC will be enrolled.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of two drugs — selinexor and talazoparib — in people with hard-to-treat solid tumors, with a focus on triple-negative breast cancer (a type of breast cancer that lacks common hormone receptors). **You may be eligible if...** - You are 18 or older with advanced or metastatic solid tumors (or specifically triple-negative breast cancer in the expansion phase) - You have never taken talazoparib or selinexor before - Your cancer is still growing despite prior treatment - You are generally healthy enough to be up and around (ECOG performance status 0–1) - Your blood counts, kidney, and liver function are adequate - You can swallow tablets **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have had another cancer recently that is still detectable - You have active brain metastases (cancer in the brain) - You have significant nerve or mental health problems - You are currently on certain strong drug interactions (specific P-gp or BCRP inhibitors) - You have poorly controlled diabetes - You had major surgery in the past 28 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTalazoparib

Patients will be treated with Talazoparib daily on a 4 weekly cycle (28 days)

DRUGSelinexor

Patients will be treated with Selinexor once per week (3 out of 4 weeks), on a 4 weekly cycle (28 days)


Locations(1)

National University Hospital

Singapore, Singapore

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NCT05035745


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