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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
Adequate organ and marrow function
Completion of induction chemotherapy, 4-6 cycles of a platinum agent and etoposide
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years upon enrollment
Awards & highlights

Study 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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My organs and bone marrow are working well.
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I have completed 4-6 cycles of chemotherapy with a platinum agent and etoposide.
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I am postmenopausal or not able to bear children, confirmed by a recent negative pregnancy test.
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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.

Timeline

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.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,466 Previous Clinical Trials
484,332 Total Patients Enrolled
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,908,310 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is this experiment accommodating?

"Affirmative, the information stored on clinicaltrials.gov states that this trial is presently seeking out participants to join it. First posted in October 5th 2020, and last modified on October 6th 2022, the study requires 24 individuals across one site."

Answered by AI

What is the fundamental goal of this experiment?

"This long-term clinical trial, with a maximum duration of 3 years post-enrollment, seeks to determine the Maximum Tolerable Dose (MTD) of Talazoparib when used in conjunction with low dose thoracic radiotherapy. Secondary objectives include assessing Loco-regional Recurrence according to RECIST v1.1 criteria and both Acute and Chronic Toxicities through CTCAE physician grading."

Answered by AI

Are researchers seeking new participants for this research initiative?

"Indeed, the data on clinicaltrials.gov confirms that this research study is seeking participants. This trial was first posted in October of 2020 and most recently edited in October 2022; it requires 24 individuals to be enrolled from one location."

Answered by AI

What risks should be taken into consideration when administering Talazoparib in tandem with Low Dose Radiotherapy (RT)?

"With limited evidence of safety and efficacy, talazoparib in combination with low dose radiotherapy was assigned a score of 1."

Answered by AI
~2 spots leftby Sep 2024