RecruitingPhase 1NCT04170946

Talazoparib and Thoracic RT for ES-SCLC

A Phase I Study of Talazoparib and Consolidative Thoracic Radiotherapy for Extensive Stage Small Cell Lung Cancer


Sponsor

University Health Network, Toronto

Enrollment

24 participants

Start Date

Oct 5, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase I, dose escalating study evaluating the safety of combining talazoparib and low dose consolidative thoracic radiotherapy for small cell lung cancer patients. This study will also determine the maximum tolerated dose (MTD) of talazoparib in combination with low dose thoracic radiotherapy. Patients will start on talazoparib on day 1 of study intervention, and will continue to orally take talazoparib until the last day of radiation therapy. Up to 24 patients will be enrolled to the study, where the first 3 patients will start with a starting dose level of talazoparib is 0.5 mg PO once daily. This will increase to 1mg daily with each new cohort.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding talazoparib (a type of PARP inhibitor drug) to chest radiation therapy improves outcomes for patients with extensive-stage small cell lung cancer (SCLC) who have already completed chemotherapy without disease progression. **You may be eligible if...** - You have been diagnosed with extensive-stage small cell lung cancer - You have completed 4–6 cycles of platinum-based chemotherapy (e.g., carboplatin + etoposide) - Your cancer has not progressed after chemotherapy - You are in reasonably good physical condition (ECOG 0–2) - Your blood counts and organ function are adequate **You may NOT be eligible if...** - Your cancer has spread to the brain (unless previously treated and stable) - You are pregnant or could become pregnant without using contraception - You have had prior chest radiation therapy - You have certain genetic conditions that affect DNA repair 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

OTHERTalazoparib in Combination with Low Dose Radiotherapy (RT)

Dose escalation model to determine the safety and MTD of talazoparib in combination with low dose RT.


Locations(1)

Princess Margaret Cancer Center, University Health Network

Toronto, Ontario, Canada

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NCT04170946


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