A Phase I Study of Olaparib and Low Dose Thoracic Radiotherapy for Extensive Stage Small Cell Lung Cancer

Memorial Sloan Kettering Cancer Center9 sites in 1 country26 target enrollmentJuly 12, 2018

ConditionsSmall-cell Lung Cancer Small Cell Lung Carcinoma

InterventionsOlaparib Pill 50 mg Olaparib Pill 100 mg Olaparib Pill 150 mg Olaparib Pill 200 mg Olaparib Pill 250 mg Olaparib Pill 300 mg Radiotherapy

DrugsOlaparib Pill 50 mg Olaparib Pill 100 mg Olaparib Pill 150 mg Olaparib Pill 200 mg Olaparib Pill 250 mg Olaparib Pill 300 mg

Overview

Phase: Phase 1
Intervention: Olaparib Pill 50 mg
Conditions: Small-cell Lung Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 26
Locations: 9
Primary Endpoint: Maximum tolerated dose (MTD) of olaparib in combination with low dose thoracic radiotherapy
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to test the safety of a new medication, Olaparib, combined with radiation therapy for participants with small cell lung cancer.

Registry

clinicaltrials.gov

Start Date

July 12, 2018

End Date

February 4, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histological documented diagnosis of SCLC confirmed by a MSKCC pathologist.
•Documented extensive disease, defined as any tumor beyond the above limited disease definition, including ipsilateral lung metastases and malignant pleural effusion
•Completion of induction chemotherapy with a minimum of 4 and no more than 6 cycles of a platinum agent and etoposide within 8 weeks of trial initiation.
•No disease progression (i.e.SD or better response per treating physician descretion) at the completion of chemotherapy.
•Age 18 years or older.
•Intrathoracic disease should be encompassable in acceptable radiation fields per investigator clinical judgement.
•Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnosfsky Performance Score (KPS) \>/= 70
•Patients must have adequately recovered from any adverse events associated with prior immune-chemotherapy
•Adequate organ and marrow function, including:
•Haemoglobin \>/= 8.0 g/dL with no blood transfusion in the past 28 days.

Exclusion Criteria

•Untreated brain metastases.
•Pneumonitis
•Previous radiotherapy to thorax (prior breast RT is permitted).
•Patient is not a candidate for or declines consolidative thoracic radiotherapy.
•Patients receiving any systemic chemotherapy or thoracic radiotherapy within 3 weeks prior to study treatment.
•Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
•Previous enrolment in the present study.
•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 olaparib, for the treatment of small cell lung cancer
•Resting ECG with QTc \> 470 msec on 2 or more time points within a 24 hour period or a documented family history of long QT syndrome.