<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03009682</url>
  </required_header>
  <id_info>
    <org_study_id>2016-03-078</org_study_id>
    <nct_id>NCT03009682</nct_id>
  </id_info>
  <brief_title>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</brief_title>
  <acronym>SUKSES-B</acronym>
  <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)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <brief_summary>
    <textblock>
      This study is a single arm, multi-center phase II study of olaparib monotherapy in patients&#xD;
      with relapsed small cell lung cancer (SCLC) harboring HR pathway gene mutations not limited&#xD;
      to BRCA 1/2 mutations, ATM deficiency or MRE11A mutations as second or third line&#xD;
      chemotherapy.&#xD;
&#xD;
      Target subject population:&#xD;
&#xD;
      Patients with small cell lung cancer that have progressed following first-line platinum-based&#xD;
      therapy. Patients must have imaging confirmed progression on 1st line chemotherapy for SCLC&#xD;
      treatment, which must have contained platinum-based regimen, with at least one measurable&#xD;
      lesion per RECIST 1.1.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2016</start_date>
  <completion_date type="Actual">January 2021</completion_date>
  <primary_completion_date type="Actual">January 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective response rate (ORR) by RECIST 1.1</measure>
    <time_frame>Up to 30 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of response</measure>
    <time_frame>Up to 30 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate</measure>
    <time_frame>at 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Up to 30 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>Up to 30 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Adverse Events as Assessed by CTCAE v4.03</measure>
    <time_frame>Up to 30 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Olaparib 300 mg</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Olaparib 300 mg BID per os every 12 hours administered daily. One cycle is consisted of 21 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Olaparib</intervention_name>
    <description>Dosage and Schedule : Olaparib 300 mg BID per os every 12 hours administered daily. One cycle is consisted of 21 days.&#xD;
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.</description>
    <arm_group_label>Olaparib 300 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision of informed consent prior to any study specific procedures&#xD;
&#xD;
          2. Small cell lung cancer that satisfies one or more of the following conditions:&#xD;
&#xD;
        1) BRCA1 or BRCA2 mutation, ATM deficiency, MRE11A mutation 2) Mutation of other&#xD;
        HR(homologous recombination) pathway genes: BLM, NBN, RAD50, RAD52, RAD54L, RAD51, RAD51B,&#xD;
        RAD51C, RAD51D, RECQL, RECQL4, RECQL5, RPA1, WRN etc.&#xD;
&#xD;
        3. Small cell lung cancer that has progressed during or after first-line therapy.&#xD;
&#xD;
          -  The 1st line regimen must have contained platinum based regimen.&#xD;
&#xD;
          -  Refractory to first-line chemotherapy or relapse within 6 months since the last dose&#xD;
             of first-line chemotherapy&#xD;
&#xD;
          -  If the patient correspond to sensitive relapse (relapse more than 6 months since the&#xD;
             last dose of first-line chemotherapy), she/he should get second- line treatment.&#xD;
&#xD;
             4. Patients (male/female) must be &gt; 20 years of age.&#xD;
&#xD;
             5. Patients must have normal organ and bone marrow function measured within 28 days&#xD;
             prior to administration of study treatment as defined below:&#xD;
&#xD;
             6. ECOG performance status 0-1 7. Patients must have a life expectancy ≥ 16 weeks 8.&#xD;
             Evidence of non-childbearing status for women of childbearing potential: negative&#xD;
             urine or serum pregnancy test within 28 days of study treatment, confirmed prior to&#xD;
             treatment on day 1 9. Patient is willing and able to comply with the protocol for the&#xD;
             duration of the study including undergoing treatment and scheduled visits and&#xD;
             examinations including follow up. 10. At least one lesion, not previously irradiated,&#xD;
             11. Provision of informed consent for genetic research.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca&#xD;
             staff and/or staff at the study site)&#xD;
&#xD;
          2. Previous enrolment in the present study&#xD;
&#xD;
          3. Participation in another clinical study with an investigational product during the&#xD;
             last 2 weeks (or a longer period depending on the defined characteristics of the&#xD;
             agents used).&#xD;
&#xD;
          4. Any previous treatment with a PARP inhibitor, including olaparib.&#xD;
&#xD;
          5. More than two prior chemotherapy regimen for the treatment of small cell lung cancer.&#xD;
             Pazopanib maintenance or immune checkpoint inhibitor (CTLA4, PD-1 or PD-L1 monoclonal&#xD;
             antibody) is not considered as line of treatment.&#xD;
&#xD;
          6. Patients with second primary cancer&#xD;
&#xD;
          7. Patients receiving any systemic chemotherapy, radiotherapy (except for palliative&#xD;
             reasons), within 2 weeks from the last dose prior to study treatment (or a longer&#xD;
             period depending on the defined characteristics of the agents used). The patient can&#xD;
             receive a stable dose of bisphosphonates or denosumab for bone metastases, before and&#xD;
             during the study as long as these were started at least 4 weeks prior to treatment&#xD;
             with study drug.&#xD;
&#xD;
          8. Concomitant use of known CYP3A4 inhibitors such as ketokonazole, itraconazole,&#xD;
             ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir&#xD;
&#xD;
          9. Persistent toxicities (&gt;=CTCAE grade 2) with the exception of alopecia, caused by&#xD;
             previous cancer therapy.&#xD;
&#xD;
         10. Resting ECG with QTc &gt; 470msec on 2 or more time points within a 24 hour period or&#xD;
             family history of long QT syndrome.&#xD;
&#xD;
         11. Patients with myelodysplastic syndrome/acute myeloid leukaemia&#xD;
&#xD;
         12. Patients with symptomatic uncontrolled brain metastases.&#xD;
&#xD;
         13. Major surgery within 14 days of starting study treatment or patients not being&#xD;
             recovered from any effects of any major surgery&#xD;
&#xD;
         14. Patients considered a poor medical risk due to a serious, uncontrolled medical&#xD;
             disorder, non-malignant systemic disease or active, uncontrolled infection.&#xD;
&#xD;
         15. Patients unable to swallow orally administered medication and patients with&#xD;
             gastrointestinal disorders likely to interfere with absorption of the study&#xD;
             medication.&#xD;
&#xD;
         16. Breast feeding women&#xD;
&#xD;
         17. Immunocompromised patients,&#xD;
&#xD;
         18. Patients with known active hepatic disease (i.e., Hepatitis B or C) due to risk of&#xD;
             transmitting the infection through blood or other body fluids.&#xD;
&#xD;
         19. Patients with a known hypersensitivity to olaparib or any of the excipients of the&#xD;
             product.&#xD;
&#xD;
         20. Patients with uncontrolled seizures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>February 16, 2021</last_update_submitted>
  <last_update_submitted_qc>February 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Keunchil Park</investigator_full_name>
    <investigator_title>professor, MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Small Cell Lung Carcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Olaparib</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03009682
org study id: 2016-03-078
nct id: NCT03009682
lead sponsor: 
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective response rate (ORR) by RECIST 1.1
time frame: Up to 30 months
measure: Duration of response
time frame: Up to 30 months
measure: Disease control rate
time frame: at 12 weeks
measure: Overall survival (OS)
time frame: Up to 30 months
measure: Progression-free survival (PFS)
time frame: Up to 30 months
measure: Number of participants with Adverse Events as Assessed by CTCAE v4.03
time frame: Up to 30 months
arm group label: Olaparib 300 mg
arm group type: Other
description: Olaparib 300 mg BID per os every 12 hours administered daily. One cycle is consisted of 21 days
intervention type: Drug
intervention name: Olaparib
description: 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.
arm group label: Olaparib 300 mg
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Keunchil Park
investigator title: professor, MD
mesh term: Lung Neoplasms
mesh term: Small Cell Lung Carcinoma
mesh term: Olaparib