<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/NCT04470141</url>
  </required_header>
  <id_info>
    <org_study_id>SHC014-II-02</org_study_id>
    <nct_id>NCT04470141</nct_id>
  </id_info>
  <brief_title>A Study of SHC014748M in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma</brief_title>
  <official_title>A Phase II, Multicenter Study to Investigate the Efficacy and Safety of SHC014748M in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanjing Sanhome Pharmaceutical, Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanjing Sanhome Pharmaceutical, Co., Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy and safety of SHC014748M in patients&#xD;
      with relapsed or refractory relapsed or refractory Peripheral T Cell Lymphoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase II, multicenter study to assess the efficacy and safety of SHC014748M, an&#xD;
      oral inhibitor of PI3K delta, in patients with relapsed or refractory peripheral T cell&#xD;
      lymphoma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2020</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Anticipated">May 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)</measure>
    <time_frame>up to 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate(DCR)</measure>
    <time_frame>up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival(PFS)</measure>
    <time_frame>up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Response(TTR)</measure>
    <time_frame>up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response(DOR)</measure>
    <time_frame>up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in the Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Scale.</measure>
    <time_frame>up to 12 months</time_frame>
    <description>The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on health related quality of life(HRQL) and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects. It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess non-Hodgkins lymphoma(NHL) related symptoms and concerns. All questions are answered on a 5-point scale ranging from &quot;not at all&quot; (0) to &quot;very much&quot; (4). Higher scores are associated with a better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and Tolerability of SHC014748M Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms.</measure>
    <time_frame>up to 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Peripheral T Cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>SHC014748M treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SHC014748M capsule, 200mg QD, 28 days for each cycle</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SHC014748M treatment</intervention_name>
    <description>Each treatment cycle is comprised of 28-day consecutive dosing of SHC014748M, 200mg QD (Days 1 to28). Upon completion of each cycle, patients may continue to receive oral SHC014748M if they can benefit from the treatment and the toxicity is tolerable.</description>
    <arm_group_label>SHC014748M treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult, male and female volunteers, above 18 years of age inclusive.&#xD;
&#xD;
          -  Histologically or cytologically confirmed diagnosis of relapsed or refractory&#xD;
             Peripheral T Cell Lymphoma,including but not limited to peripheral T-cell&#xD;
             lymphoma-unspecified(PTCL-U),angioimmunoblastic T-cell&#xD;
             lymphoma(AITL),ALK+/ALK-anaplastic large cell lymphoma(ALCL),subcutaneous&#xD;
             panniculitis-like T-cell lymphoma(SPTL). Eligible patients have failed or progressed&#xD;
             at least one standard treatment, have no standard treatment, or are intolerant for&#xD;
             standard treatment at this stage as determined by the investigator.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.&#xD;
&#xD;
          -  Life expectancy ≥ 3 months.&#xD;
&#xD;
          -  Patients have at least 1 measurable lesion that measures ≥1.5 cm in a single dimension&#xD;
             as assessed by CT or MRI.&#xD;
&#xD;
          -  Adequate organ function, as defined by the following&#xD;
             values:ANC≥1.0×10^9/L;PLT≥50×10^9/L;Hb≥80 g/L;TBIL≤2×ULN(TBIL&gt;2×ULN for subjects with&#xD;
             Gilbert syndrome,TBIL&gt;3×ULN for subjects with focal compression of bile duct as&#xD;
             determined by investigators);ALT and AST≤2.5×ULN(ALT and AST≤5×ULN for subjects with&#xD;
             impaired liver function caused by hepatic infiltration as determined by&#xD;
             investigators);CLcr&gt; 50 mL/min(according to Cockcroft-Gault).&#xD;
&#xD;
          -  Men and women of childbearing potential are willing to employ an effective method of&#xD;
             contraception for the entire duration of study and 6 months after the last dose, and&#xD;
             female subjects of childbearing potential have a negative pregnancy test at baseline.&#xD;
&#xD;
          -  Volunteers did not participate in other clinical trials within 1 month prior to study&#xD;
             entry.&#xD;
&#xD;
          -  Provision of signed and dated, written informed consent prior to any study-specific&#xD;
             evaluation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous treatment with any PI3Kδ inhibitors.&#xD;
&#xD;
          -  Had any other anti-tumor treatment within 4 weeks prior to screening(including&#xD;
             radiotherapy, chemotherapy, Chinese herbal anti-tumor treatment and major surgery);&#xD;
             targeted therapy with 5 half-life period prior to the first dose of study drug.&#xD;
&#xD;
          -  Evidence of central nervous system involvement of the malignancy,including invasion of&#xD;
             brain parenchyma and meninges, or spinal cord compression.&#xD;
&#xD;
          -  Evidence of severe or uncontrolled systemic diseases, including uncontrolled&#xD;
             hypertension, active bleeding diatheses, uncontrolled pleural effusion and ascites,&#xD;
             uncontrolled diabetes, severe or debilitating lung disease.&#xD;
&#xD;
          -  Have moderate or severe cardiac disease, including but not limited to severe&#xD;
             arrhythmias or abnormal cardiac conduction, such as ventricular arrhythmias requiring&#xD;
             clinical intervention, degree II-III atrioventricular block,QTcF≥450 ms for male,&#xD;
             QTcF≥470 ms for female, or other structural heart disease with high risk as determined&#xD;
             by investigators;history of acute coronary syndrome, congestive heart failure,aortic&#xD;
             dissection,stroke or other≥grade 3 cardiovascular and cerebrovascular events within 6&#xD;
             months prior to the first dose of study drug;New York Heart Association (NYHA) Class&#xD;
             II or greater heart failure, or LVEF&lt;55%;uncontrolled hypertension(systolic blood&#xD;
             pressure&gt;180 mmHg or diastolic blood pressure&gt;100 mmHg with two measurements in a&#xD;
             row);any risk factors to increase QTc or arrhythmias, including heart&#xD;
             failure,hypokalemia,congenital long QTc syndrome,family history of long QT interval&#xD;
             syndrome or history of unexplained sudden death occurred in first degree relative less&#xD;
             than 40 years of age, or using any concomitant medication known to produce QTc&#xD;
             prolongation.&#xD;
&#xD;
          -  Evidence of active bacterial, fungal, or viral infection, and need systemic treatment&#xD;
             with one week prior to the first dose of study drug.&#xD;
&#xD;
          -  Infection with hepatitis B virus(HBV) ( volunteers with HBsAg positive but HBV-DNA&#xD;
             negative, or volunteers with HCV antibody positive but HCV-RNA negative can be&#xD;
             enrolled), hepatitis C virus(HCV), syphilis,or human immunodeficiency virus (HIV).&#xD;
&#xD;
          -  Have systematic hormonal therapy(prednisone&gt;20mg/d or similar drugs with equivalent&#xD;
             dose)or immunosuppressor therapy with 14 days prior to the first dose of study drug,&#xD;
             except using topical,ocular,intra-articular,intranasal,inhaled corticosteroids,and&#xD;
             preventive therapy using corticosteroids in short period(for instance,to prevent&#xD;
             hypersensitivity to contrast media).&#xD;
&#xD;
          -  Concomitant use of any strong inhibitors or inducers of CYP3A4(except drug withdrawal&#xD;
             prior to the first dose of study drug).&#xD;
&#xD;
          -  History of immune deficiency(acquired and congenital), or history of organ&#xD;
             transplantation, or allogeneic bone marrow or hematopoietic stem cell transplantation;&#xD;
             with active autoimmune disease or history of autoimmune disease including Interstitial&#xD;
             pneumonia, autoimmune enteritis, autoimmune hepatitis and systemic lupus&#xD;
             erythematosus.&#xD;
&#xD;
          -  Prior autologous hematopoietic stem cell transplantation within 2 months prior to the&#xD;
             first dose of study drug.&#xD;
&#xD;
          -  History of any uncured malignant tumor in the past five years except for the&#xD;
             following: clinically cured cervical or breast carcinoma in situ, local basal cell or&#xD;
             squamous cell carcinoma of the skin, thyroid tumor.&#xD;
&#xD;
          -  Severe gastrointestinal disease affecting ingesting, transporting and absorbing of the&#xD;
             study drug, include inability to swallow the drug,malabsorption&#xD;
             syndrome,uncontrollable nausea and vomiting,history of extensive gastrointestinal&#xD;
             resection,uncurable recurrent diarrhea,atrophic gastritis(age of onset&lt;60),uncurable&#xD;
             severe gastric diseases,crohn's disease,ulcerative colitis or complete Intestinal&#xD;
             obstruction.&#xD;
&#xD;
          -  Adverse events occurred during previous anticancer therapy have not been recovered to&#xD;
             ≤1(CTCAE 5.0)except toxicity with no significant risk determined by investigators such&#xD;
             as alopecia.&#xD;
&#xD;
          -  History of hypersensitivity to the main composition or any inactive excipient of the&#xD;
             study drug.&#xD;
&#xD;
          -  Women who are breastfeeding.&#xD;
&#xD;
          -  With basic medical condition leading to risk of taking study drugs judged by&#xD;
             investigators, or with confusion to toxicity and adverse events.&#xD;
&#xD;
          -  Judgment by the investigator that the patient should not participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 12, 2020</last_update_submitted>
  <last_update_submitted_qc>July 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PTCL</keyword>
  <keyword>SHC014748M</keyword>
  <keyword>Phosphatidylinositol 3-kinase (PI3K)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, T-Cell</mesh_term>
    <mesh_term>Lymphoma, T-Cell, Peripheral</mesh_term>
  </condition_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/NCT04470141
org study id: SHC014-II-02
nct id: NCT04470141
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the efficacy and safety of SHC014748M in patients
      with relapsed or refractory relapsed or refractory Peripheral T Cell Lymphoma.
This is a phase II, multicenter study to assess the efficacy and safety of SHC014748M, an
      oral inhibitor of PI3K delta, in patients with relapsed or refractory peripheral T cell
      lymphoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate (ORR)
time frame: up to 12 months
measure: Disease Control Rate(DCR)
time frame: up to 12 months
measure: Progression-Free Survival(PFS)
time frame: up to 12 months
measure: Time to Response(TTR)
time frame: up to 12 months
measure: Duration of Response(DOR)
time frame: up to 12 months
measure: Mean Change From Baseline in the Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Scale.
time frame: up to 12 months
description: The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on health related quality of life(HRQL) and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects. It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess non-Hodgkins lymphoma(NHL) related symptoms and concerns. All questions are answered on a 5-point scale ranging from "not at all" (0) to "very much" (4). Higher scores are associated with a better quality of life.
measure: Safety and Tolerability of SHC014748M Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms.
time frame: up to 12 months
arm group label: SHC014748M treatment
arm group type: Experimental
description: SHC014748M capsule, 200mg QD, 28 days for each cycle
intervention type: Drug
intervention name: SHC014748M treatment
description: Each treatment cycle is comprised of 28-day consecutive dosing of SHC014748M, 200mg QD (Days 1 to28). Upon completion of each cycle, patients may continue to receive oral SHC014748M if they can benefit from the treatment and the toxicity is tolerable.
arm group label: SHC014748M treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, T-Cell
mesh term: Lymphoma, T-Cell, Peripheral