Testing Talazoparib in Combination with Low for lung cancer
Official title: Talazoparib and Thoracic RT for ES-SCLC
A Phase I Study of Talazoparib and Consolidative Thoracic Radiotherapy for Extensive Stage Small Cell Lung Cancer
- Phase 1
- 1 group
- One site, in Toronto
- Recruiting
Interventions
- Other intervention
Talazoparib in Combination with Low Dose Radiotherapy (RT)
Dose escalation model to determine the safety and MTD of talazoparib in combination with low dose RT.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Princess Margaret Cancer Center, University Health Network
Toronto, Ontario
Eligibility Criteria
See who this study is looking for24 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnosfsky Performance Score (KPS) ≥50; see Appendix B).
- +Histological documented diagnosis of SCLC confirmed by a UHN pathologist.
- +Documented extensive disease
- +Adequate organ and marrow function,
- +Postmenopausal or evidence of non-childbearing status for women of childbearing potential negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1.
- +Completion of induction chemotherapy, 4-6 cycles of a platinum agent and etoposide.
- +No disease progression (i.e.SD or better response by RECIST 1.1) at the completion of chemotherapy.
Exclusion
- −Untreated brain metastases.
- −Previous radiotherapy to thorax (prior breast RT is permitted).
- −Exposure to an investigational product within 30 days or 5 half-lives (whichever is longer) prior to start of the current study drug.
- −Any previous treatment with PARP inhibitor, including talazoparib.
- −Concomitant use of strong P-gp inhibitors
- −Concomitant use of other known P-gp inhibitors, P-gp inducers, or BCRP inhibitors
- −Persistent toxicities (\>Common Terminology Criteria for Adverse EventAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia.
- −Patients with myelodysplastic syndrome/acute leukaemia or with features suggestive thereof.
- −Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active/uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- −Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
- −Immunocompromised patients,
- −Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
- −Whole blood transfusions in the last 120 days prior to entry to the study
- −Other malignancy within the last 5 years
- −Patients with spinal cord compression
- −Patients receiving any systemic chemotherapy, radiotherapy or immunotherapy (except for standard of careStandard of careThe treatment normally given for a condition outside a study.Read more → treatments or palliative reasons) within 3 weeks prior to study treatment.
- −Major surgery within 2 weeks of study treatment initiation and patients must have recovered from any effects of any major surgery.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more → — an early safety study in a small group, checking how it is tolerated and at what dose.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group and receives Talazoparib in Combination with Low Dose Radiotherapy (RT).
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 24 people.
The study is currently expected to finish around September 2027.
The main measurement is taken over: Up to 3 years upon enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Safety of Talazoparib in Combination with Low Dose Thoracic Radiotherapy — measured over Up to 3 years upon enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
Maximum Tolerated DoseMaximum tolerated doseThe highest amount that can be given before side effects become unacceptable.Read more → (MTD) of Talazoparib in Combination with Low Dose Thoracic Radiotherapy — measured over Up to 1 year.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04170946 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Talazoparib in Combination with Low Dose Radiotherapy (RT)Other
Dose escalation model to determine the safety and MTD of talazoparib in combination with low dose RT.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 3 years upon enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
The study as a whole is currently expected to finish around 2027-09.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 24 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.