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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olaparib 300 mg | Other | Olaparib 300 mg BID per os every 12 hours administered daily. One cycle is consisted of 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olaparib | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) by RECIST 1.1 | Up to 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response | Up to 30 months | |
| Disease control rate | at 12 weeks | |
| Overall survival (OS) |
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Inclusion Criteria:
1) BRCA1 or BRCA2 mutation, ATM deficiency, MRE11A mutation 2) Mutation of other HR(homologous recombination) pathway genes: BLM, NBN, RAD50, RAD52, RAD54L, RAD51, RAD51B, RAD51C, RAD51D, RECQL, RECQL4, RECQL5, RPA1, WRN etc.
3. Small cell lung cancer that has progressed during or after first-line therapy.
The 1st line regimen must have contained platinum based regimen.
Refractory to first-line chemotherapy or relapse within 6 months since the last dose of first-line chemotherapy
If the patient correspond to sensitive relapse (relapse more than 6 months since the last dose of first-line chemotherapy), she/he should get second- line treatment.
4. Patients (male/female) must be > 20 years of age.
5. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
6. ECOG performance status 0-1 7. Patients must have a life expectancy ≥ 16 weeks 8. Evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1 9. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. 10. At least one lesion, not previously irradiated, 11. Provision of informed consent for genetic research.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
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|
| Up to 30 months |
| Progression-free survival (PFS) | Up to 30 months |
| Number of participants with Adverse Events as Assessed by CTCAE v4.03 | Up to 30 months |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C531550 | olaparib |
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