Ignite Creation Date:
2024-05-06 @ 4:16 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04939662
Status:
COMPLETED
Last Update Posted:
2024-01-02
First Post:
2021-06-02
Brief Title:
Olaparib and Bevacizumab in Relapsed Small Cell Lung Cancer Subjects
Sponsor:
Se-Hoon Lee
Organization:
Samsung Medical Center
Study Overview
Official Title:
Phase II Single-arm Study of Olaparib and Bevacizumab Combination Therapy in Relapsed Small Cell Lung Cancer Subjects With DNA Damage Response and the Repair Pathway Alteration ATM Deficiency SLFN11 Positive or POU2F3 Positive
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUKSES-B2
Brief 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 mgkg via IV administered on Day 1 of every cycle for every 3 weeks One cycle consists of 21 days
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 mgkg via IV administered on Day 1 of every cycle for every 3 weeks One cycle consists of 21 days
Detailed Description:
Study design 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 mgkg via IV administered on Day 1 of every cycle for every 3 weeks One cycle consists of 21 days
Tumour evaluation by RECIST v11 using CT or MRI scans of chest abdomen pelvis and brain optional in case of brain metastases CEA NSE and LDH will be conducted at screening within 28 days prior to first dose of Cycle1 Day1 and every 6 weeks 1 week for the first 42 weeks relative to the start of combination therapy Cycle 1 Day 1 and thereafter every 9 weeks 1week until objective disease progression
Study treatment will be continued until objective disease progression unless other criteria for treatment discontinuation are met Subjects may continue olaparib and bevacizumab beyond progression according to RECIST 11 at the discretion of the investigator if they are clinically benefiting from the treatment and they do not meet any other discontinuation criteria
If a subjects discontinues study treatment prior to disease progression they should continue to be assessed using RECIST 11 until disease progression and then followed up for survival
Assessments for survival should be made every 3months following objective disease progression The details of first and subsequent therapies for cancer after discontinuation of olaparib and bevacizumab treatment will be collected
The imaging modalities used for RECIST 11 assessment will be CT or MRI scans of chest abdomen and pelvis And CEA NSE and LDH tests are also used for the evaluation RECIST 11 scans will be analysed by the investigator on site
Subjects may also be requested to provide tumour samples from the primary or metastatic tumours on progression to understand resistance mechanisms Sample provision is optional and depend on the subjects will
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 mgkg via IV administered on Day 1 of every cycle for every 3 weeks One cycle consists of 21 days
Tumour evaluation by RECIST v11 using CT or MRI scans of chest abdomen pelvis and brain optional in case of brain metastases CEA NSE and LDH will be conducted at screening within 28 days prior to first dose of Cycle1 Day1 and every 6 weeks 1 week for the first 42 weeks relative to the start of combination therapy Cycle 1 Day 1 and thereafter every 9 weeks 1week until objective disease progression
Study treatment will be continued until objective disease progression unless other criteria for treatment discontinuation are met Subjects may continue olaparib and bevacizumab beyond progression according to RECIST 11 at the discretion of the investigator if they are clinically benefiting from the treatment and they do not meet any other discontinuation criteria
If a subjects discontinues study treatment prior to disease progression they should continue to be assessed using RECIST 11 until disease progression and then followed up for survival
Assessments for survival should be made every 3months following objective disease progression The details of first and subsequent therapies for cancer after discontinuation of olaparib and bevacizumab treatment will be collected
The imaging modalities used for RECIST 11 assessment will be CT or MRI scans of chest abdomen and pelvis And CEA NSE and LDH tests are also used for the evaluation RECIST 11 scans will be analysed by the investigator on site
Subjects may also be requested to provide tumour samples from the primary or metastatic tumours on progression to understand resistance mechanisms Sample provision is optional and depend on the subjects will
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None