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New treatment option for Lung Cancer
Official title Talazoparib and Thoracic RT for ES-SCLC
ClinicalTrials.gov ID: NCT04170946
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histological documented diagnosis of SCLC confirmed by a UHN pathologist.
- Documented extensive disease
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnosfsky Performance Score (KPS) ≥50; see Appendix B).
You likely can't join if
- Untreated brain metastases.
- Previous radiotherapy to thorax (prior breast RT is permitted).
- Patients receiving any systemic chemotherapy, radiotherapy or immunotherapy (except for standard of care treatments or palliative reasons) within 3...
- 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
See the full eligibility criteria
- Histological documented diagnosis of SCLC confirmed by a UHN pathologist.
- Documented extensive disease
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnosfsky Performance Score (KPS) ≥50; see Appendix B).
- 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.
- Untreated brain metastases.
- Previous radiotherapy to thorax (prior breast RT is permitted).
- Patients receiving any systemic chemotherapy, radiotherapy or immunotherapy (except for standard of care treatments or palliative reasons) within 3 weeks prior to study treatment.
- 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 Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia.
- Patients with myelodysplastic syndrome/acute leukaemia or with features suggestive thereof.
- Major surgery within 2 weeks of study treatment initiation and patients must have recovered from any effects of any major surgery.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.