Olaparib and Bevacizumab in Relapsed Small Cell Lung Cancer Subjects
NCT04939662 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2024-01-02
Summary
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.
Conditions
Interventions
- DRUG
-
Olaparib+Bevacizumab to SCLC patients
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.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Roche Pharma AG
collaborator INDUSTRY -
Se-Hoon Lee
lead OTHER
Principal Investigators
-
Se-Hoon Lee, Professor · Samsung Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-11
- Primary Completion
- 2023-10-27
- Completion
- 2023-10-27
Countries
- South Korea
Study Locations
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