Olaparib and Bevacizumab in Relapsed Small Cell Lung Cancer Subjects

Sponsor
Se-Hoon Lee
Study ID
NCT04939662
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olaparib+Bevacizumab to SCLC patients — DRUG
    Olaparib 300 mg bid per os every 12 hours D1-21 administered in each cycle days. One cycle consists of 21 days. Bevacizumab 15 mg/kg via IV administered on Day1 of each cycle. One cycle is consisted of 21 days. The subject's body weight criterion is based on C1D1 (first dose date), and if more than 10% of BW is increased and decreased, the drug dose is changed to that BW.

Study Details

This study is a single arm, multi-centre phase II study of olaparib and bevacizumab combination therapy in subjects with relapsed small cell lung cancer (SCLC) as a second or third line (systemic) therapy. Subjects will receive olaparib and bevacizumab combination therapy. The arm is composed of 28 subjects. Olaparib 300 mg bid per os every 12 hours administered each cycle day and bevacizumab 15 mg/kg via IV administered on Day 1 of every cycle for every 3 weeks. One cycle consists of 21 days.

Key Dates

Start date
Jun 11, 2021
Status verified
Dec 2023
Primary completion
Oct 27, 2023
Completion
Oct 27, 2023

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Olaparib+Bevacizumab to SCLC patients
    Regimen and administration: Administration of olaparib Olaparib 300 mg bid per os every 12 hours D1-21 administered in each cycle days. One cycle consists of 21 days. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water. Administration of bevacizumab Bevacizumab 15 mg/kg via IV administered on Day1 of each cycle. One cycle is consisted of 21 days. The subject's body weight criterion is based on C1D1 (first dose date), and if more than 10% of BW is increased and decreased, the drug dose is changed to that BW.

Primary Outcome Measure

Objective response rate (ORR) by RECIST 1.1 [ Time Frame: through study completion, an average of 1 year ]

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