Talazoparib and Thoracic RT for ES-SCLC

NCT04170946

Last updated date
Study Location
Princess Margaret Cancer Center, University Health Network
Toronto, Ontario, M5G 2M9, Canada
Contact
416-946-4501

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By email

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Lung Cancer, Small-Cell Lung Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Lung Cancer, Small-Cell Lung CancerTalazoparib and Thoracic RT for ES-SCLC
NCT04170946
  1. Toronto, Ontario
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • Lung Cancer
  • Small-Cell Lung Cancer
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
 (submitted: November 18, 2019)
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:

  • 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.

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Benjamin Lok, MD416-946-4501 ext 5819[email protected]
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Benjamin Lok, MDPrincess Margaret Cancer Center
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