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PARP Inhibitor

Talazoparib + Radiotherapy for Small Cell Lung Cancer

Phase 1

Recruiting

Led By Benjamin Lok, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Completion of induction chemotherapy, 4-6 cycles of a platinum agent and etoposide

Documented extensive disease

Must not have

Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)

Concomitant use of other known P-gp inhibitors, P-gp inducers, or BCRP inhibitors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years upon enrollment

Awards & highlights

Summary

This trial is testing whether combining talazoparib with low dose consolidative thoracic radiotherapy is safe and what the maximum tolerated dose is. Patients will take talazoparib orally once daily starting on the first day of study intervention until the last day of radiation therapy.

Who is the study for?

This trial is for adults with extensive-stage small cell lung cancer who finished 4-6 cycles of specific chemotherapy without disease progression. They must be able to swallow pills, have good organ function, and not be pregnant or breastfeeding. Excluded are those with untreated brain metastases, prior PARP inhibitor treatment, recent other cancer treatments, serious medical conditions or infections.Check my eligibility

What is being tested?

The study tests the safety of combining talazoparib (a pill) with low dose thoracic radiotherapy in escalating doses to find the highest dose patients can tolerate without severe side effects. Up to 24 patients will start at a lower dose and may increase if it's safe.See study design

What are the potential side effects?

Potential side effects include typical reactions from radiation therapy like skin changes and fatigue as well as possible effects from talazoparib such as blood disorders, nausea, vomiting, fatigue and risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have completed 4-6 cycles of chemotherapy with a platinum agent and etoposide.

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My cancer has spread extensively.

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My cancer did not worsen after chemotherapy.

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I can take care of myself but might not be able to do heavy physical work.

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My small cell lung cancer diagnosis was confirmed by a UHN pathologist.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a bone marrow or cord blood transplant in the past.

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I am not taking any drugs that affect drug transport in my body.

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I am not taking strong P-gp inhibitors.

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I have spinal cord compression.

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I have had radiation therapy to the chest area before, but not for breast cancer.

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I cannot swallow pills or have stomach issues affecting medication absorption.

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I have lasting side effects from cancer treatment, but not hair loss.

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I have brain metastases that have not been treated.

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I have never been treated with a PARP inhibitor like talazoparib.

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I do not have any serious, uncontrolled health conditions or active infections.

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My immune system is weakened.

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I have not had major surgery in the last 2 weeks or have fully recovered from one.

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I have been diagnosed with myelodysplastic syndrome or acute leukemia.

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I have not had any other cancer in the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years upon enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years upon enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years upon enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose (MTD) of Talazoparib in Combination with Low Dose Thoracic Radiotherapy

Safety of Talazoparib in Combination with Low Dose Thoracic Radiotherapy

Secondary outcome measures

Acute Toxicities

Chronic Toxicities

Loco-regional Recurrence

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Talazoparib in Combination with Low Dose RTExperimental Treatment1 Intervention

Patients will start on talazoparib on day 1 of study intervention, and will continue to orally take talazoparib until the last day of RT (until day 20-23). Patient will start low dose RT on day 6-9, and will continue for 10 fractions throughout 2 weeks. Talazoparib dose levels will start at 0.5mg daily and increase to 1mg if dose limiting toxicites are not observed. Toxicities include renal impairment and other treatment related toxicities Grade ≥3. Patients will be monitored weekly during study treatment, and followed up at 3 weeks, and every 3 months after for 1 year.

0 / 19Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,492 Previous Clinical Trials

490,020 Total Patients Enrolled

PfizerIndustry Sponsor

4,595 Previous Clinical Trials

12,868,746 Total Patients Enrolled

Benjamin Lok, MDPrincipal InvestigatorPrincess Margaret Cancer Center

Media Library

Talazoparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04170946 — Phase 1

Small Cell Lung Cancer Clinical Trial 2023: Talazoparib Highlights & Side Effects. Trial Name: NCT04170946 — Phase 1

Talazoparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04170946 — Phase 1

~1 spots leftby Sep 2024

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