ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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- 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) ≥70; 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 or radiotherapy (except for 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 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 consent
- 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
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- Toronto, Ontario
Descriptive Information | |||||||
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Brief Title ICMJE | Talazoparib and Thoracic RT for ES-SCLC | ||||||
Official Title ICMJE | A Phase I Study of Talazoparib and Consolidative Thoracic Radiotherapy for Extensive Stage Small Cell Lung Cancer | ||||||
Brief Summary | 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. | ||||||
Detailed Description | This is a phase I, dose escalating study evaluating the safety of combination talazoparib and low dose consolidative thoracic radiotherapy for extensive-stage small cell lung cancer patients with at least stable disease after standard of care 4 - 6 cycles of chemotherapy (a platinum agent and etoposide). This study will also determine the maximum tolerated dose (MTD) of talazoparib in combination with low dose thoracic radiotherapy. Secondary objectives will be to examine clinical outcomes, including locoregional recurrence within the radiation field, progression-free survival, overall survival and acute/chronic toxicities up to 1 year. Patients will start on talazoparib on day 1 of study intervention, and will continue to orally take talazoparib until the last day of RT. Patient will start low dose RT on day 6-9, and will continue for 10 fractions throughout 2 weeks. 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. Patients will be monitored weekly during study treatment, and followed up at 3 weeks, and every 3 months after for 1 year. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 | ||||||
Study Design ICMJE | Intervention Model: Sequential Assignment Intervention Model Description: Dose escalation based on the maximum tolerated dose from each previous cohort within the study. Masking: None (Open Label)Primary Purpose: Treatment | ||||||
Condition ICMJE |
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Intervention ICMJE | Other: 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. | ||||||
Study Arms ICMJE | Experimental: Talazoparib in Combination with Low Dose RT
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. Intervention: Other: Talazoparib in Combination with Low Dose Radiotherapy (RT) | ||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE | 24 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | February 2024 | ||||||
Estimated Primary Completion Date | February 2023 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Canada | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04170946 | ||||||
Other Study ID Numbers ICMJE | UHN REB 19-5621 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | University Health Network, Toronto | ||||||
Study Sponsor ICMJE | University Health Network, Toronto | ||||||
Collaborators ICMJE | Pfizer | ||||||
Investigators ICMJE |
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PRS Account | University Health Network, Toronto | ||||||
Verification Date | September 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |