A Study of Olaparib and Low Dose Radiotherapy for Small Cell Lung Cancer

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.

Conditions

• Small-cell Lung Cancer
• Small Cell Lung Carcinoma

Interventions

DRUG

Olaparib Pill 50 mg

Olaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water. Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23)

DRUG

Olaparib Pill 100 mg

Olaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water. Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23)

DRUG

Olaparib Pill 150 mg

Olaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water. Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23)

DRUG

Olaparib Pill 200 mg

Olaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water. Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23)

DRUG

Olaparib Pill 250 mg

Olaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water. Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23)

DRUG

Olaparib Pill 300 mg

Olaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water. Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23)

RADIATION

Radiotherapy

The total prescribed dose will be 30 Gy in ten daily fractions of 3 Gy each delivered during business days over 2 calendar weeks.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center

  lead OTHER

Principal Investigators

• Abraham Wu, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-12

Primary Completion

2025-02-04

Completion

2025-02-04

FDA Drug

Yes

Countries

• United States

Study Locations