Olaparib Monotherapy in Relapsed Small Cell Lung Cancer Patients With HR Pathway Gene Mutations Not Limited to BRCA 1/2 Mutations, ATM Deficiency or MRE11A Mutations (SUKSES-B)
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|ClinicalTrials.gov Identifier: NCT03009682|
Recruitment Status : Completed
First Posted : January 4, 2017
Last Update Posted : February 18, 2021
This study is a single arm, multi-center phase II study of olaparib monotherapy in patients with relapsed small cell lung cancer (SCLC) harboring HR pathway gene mutations not limited to BRCA 1/2 mutations, ATM deficiency or MRE11A mutations as second or third line chemotherapy.
Target subject population:
Patients with small cell lung cancer that have progressed following first-line platinum-based therapy. Patients must have imaging confirmed progression on 1st line chemotherapy for SCLC treatment, which must have contained platinum-based regimen, with at least one measurable lesion per RECIST 1.1.
|Condition or disease||Intervention/treatment||Phase|
|Small Cell Lung Cancer||Drug: Olaparib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II, Single-arm Study of Olaparib Monotherapy in Relapsed Small Cell Lung Cancer Patients With HR Pathway Gene Mutations Not Limited to BRCA 1/2 Mutations, ATM Deficiency or MRE11A Mutations(SUKSES-B)|
|Actual Study Start Date :||August 2016|
|Actual Primary Completion Date :||January 2021|
|Actual Study Completion Date :||January 2021|
Olaparib 300 mg
Olaparib 300 mg BID per os every 12 hours administered daily. One cycle is consisted of 21 days
Dosage and Schedule : Olaparib 300 mg BID per os every 12 hours administered daily. One cycle is consisted of 21 days.
Two x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 mL of water. The olaparib tablets should be swallowed whole and not chewed, crushed, dissolved or divided. Olaparib can be taken with a light meal/snack.
- Objective response rate (ORR) by RECIST 1.1 [ Time Frame: Up to 30 months ]
- Duration of response [ Time Frame: Up to 30 months ]
- Disease control rate [ Time Frame: at 12 weeks ]
- Overall survival (OS) [ Time Frame: Up to 30 months ]
- Progression-free survival (PFS) [ Time Frame: Up to 30 months ]
- Number of participants with Adverse Events as Assessed by CTCAE v4.03 [ Time Frame: Up to 30 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03009682
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of, 135-710|