Your session is about to expire
← Back to Search
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
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 belowSelect...
I have completed 4-6 cycles of chemotherapy with a platinum agent and etoposide.
Select...
My cancer has spread extensively.
Select...
My cancer did not worsen after chemotherapy.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My small cell lung cancer diagnosis was confirmed by a UHN pathologist.
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
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 moreTrial 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
1,472 Previous Clinical Trials
484,969 Total Patients Enrolled
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,910,454 Total Patients Enrolled
Benjamin Lok, MDPrincipal InvestigatorPrincess Margaret Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a bone marrow or cord blood transplant in the past.My organs and bone marrow are working well.I am not taking any drugs that affect drug transport in my body.I am not taking strong P-gp inhibitors.I have spinal cord compression.I have completed 4-6 cycles of chemotherapy with a platinum agent and etoposide.I have had radiation therapy to the chest area before, but not for breast cancer.I haven't had chemotherapy, radiotherapy, or immunotherapy in the last 3 weeks.I am postmenopausal or not able to bear children, confirmed by a recent negative pregnancy test.I have not received a whole blood transfusion in the last 120 days.I cannot swallow pills or have stomach issues affecting medication absorption.I have lasting side effects from cancer treatment, but not hair loss.I have brain metastases that have not been treated.I have never been treated with a PARP inhibitor like talazoparib.I do not have any serious, uncontrolled health conditions or active infections.My immune system is weakened.My cancer has spread extensively.I have not had major surgery in the last 2 weeks or have fully recovered from one.My cancer did not worsen after chemotherapy.I can take care of myself but might not be able to do heavy physical work.I have been diagnosed with myelodysplastic syndrome or acute leukemia.I have not had any other cancer in the last 5 years.My small cell lung cancer diagnosis was confirmed by a UHN pathologist.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger