<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/NCT02201823</url>
  </required_header>
  <id_info>
    <org_study_id>ABT-C1-2013</org_study_id>
    <secondary_id>2013-001293-17</secondary_id>
    <secondary_id>PEI 13-057</secondary_id>
    <nct_id>NCT02201823</nct_id>
  </id_info>
  <brief_title>Phase I/Ib Clinical Trial of ABTL0812 in Advanced Cancer Patients</brief_title>
  <official_title>A PHASE I/Ib, FIRST IN HUMAN, DOSE-ESCALATION STUDY OF ABTL0812 IN PATIENTS WITH ADVANCED SOLID TUMOURS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ability Pharmaceuticals SL</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Clinic of Barcelona</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut Català d'Oncologia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ability Pharmaceuticals SL</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ability Pharmaceuticals promotes a clinical trial to determine the adequate dose of a new&#xD;
      drug, ABTL0812, that will be administered orally daily to patients with advanced solid&#xD;
      tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase I/Ib, unicenter, open-label and single-agent study. This study consists of&#xD;
      two different parts, a dose escalation phase and an extension phase in patients with advanced&#xD;
      solid tumors.&#xD;
&#xD;
      ABTL0812 will be administered orally, daily, for 28 days (considered cycle 1). First endpoint&#xD;
      is to determine the Maximum Tolerated Dose (MTD). MTD is defined as the highest dose at which&#xD;
      no more than one in six patients experiences a ABTL0812 related Dose-Limiting Toxicity (DLT).&#xD;
      DLT will be evaluated during the first treatment cycle.&#xD;
&#xD;
      Dose escalation phase will be performed with an accelerated design of 3 + 3&#xD;
&#xD;
      Once the 28 days cycle has finished, patients may continue receiving ABTL0812 on a daily&#xD;
      continuous schedule if the patient is deemed to have clinical benefit from treatment,&#xD;
      according to the treating physician. Treatment will continue until disease progression, onset&#xD;
      of unacceptable drug toxicities, or patient/physician's request to discontinue.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>Phase 1</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>To determine the maximum tolerated dose (MTD) of ABTL0812, administered orally on a daily continuous schedule in adult patients with advanced solid tumours</measure>
    <time_frame>First 28 days of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To assess safety and tolerability of ABTL0812</measure>
    <time_frame>First 28 days of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate preliminary antitumour activity of ABTL0812</measure>
    <time_frame>After 6 months of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the recommended Phase II dose</measure>
    <time_frame>First 28 days of treatment</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>To evaluate the pharmacokinetic (PK) profile of ABTL0812 in patients with advanced solid tumours</measure>
    <time_frame>First 28 days of treatment</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>To evaluate the pharmacodynamic (PD) profile of ABTL0812 exploring preliminary biomarkers of drug activity</measure>
    <time_frame>First 28 days of treatment</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>ABTL0812</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABTL0812 oral</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABTL0812</intervention_name>
    <description>ABTL0812. Five cohorts and one extension phase.</description>
    <arm_group_label>ABTL0812</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years of age&#xD;
&#xD;
          -  Willing and able to provide informed consent&#xD;
&#xD;
          -  Patients with histologically or cytologically confirmed diagnosis of advanced solid&#xD;
             tumour refractory to standard treatment or for whom no effective therapy exists&#xD;
&#xD;
          -  Evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version&#xD;
             1.1 guidelines&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2&#xD;
&#xD;
          -  All female subjects will be considered to be of childbearing potential unless they are&#xD;
             postmenopausal (at least 12 months consecutive amenorrhea, in the appropriate age&#xD;
             group and without other known or suspected cause), or have been sterilized surgically&#xD;
             Female subjects of childbearing potential must agree to use two forms of highly&#xD;
             effective contraception methods during the study and for a period of 6 months&#xD;
             following the last administration of the study drug. Male subjects and their female&#xD;
             partners who are of childbearing potential and are not practicing total abstinence,&#xD;
             must agree to use two forms of highly effective contraception during the study and for&#xD;
             a period of 6 months following the last administration of the study drug&#xD;
&#xD;
          -  Adequate bone marrow function&#xD;
&#xD;
          -  Adequate coagulation profile&#xD;
&#xD;
          -  Adequate hepatic function&#xD;
&#xD;
          -  Adequate renal function&#xD;
&#xD;
          -  Life expectancy of at least 3 months, in the opinion of the investigator&#xD;
&#xD;
          -  Toxicities incurred as a result of previous anticancer therapy (radiation therapy,&#xD;
             chemotherapy, or surgery) must be resolved to ≤ grade 1 (as defined by Common&#xD;
             Terminology Criteria for Adverse Events version 4.02).&#xD;
&#xD;
          -  Ability and willingness to comply with study visits, treatment, testing, and to comply&#xD;
             with the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients receiving treatment within 4 weeks prior to study entry with an&#xD;
             investigational drug, chemotherapy, targeting agents or hormonal therapy (patients may&#xD;
             continue to receive Luteinizing-hormone-releasing hormone analogue therapy for&#xD;
             prostate cancer in face of rising PSA), radiation (except to bone) or surgery (except&#xD;
             exploratory biopsy or intravenous device implantation, etc.) (6 weeks for nitrosoureas&#xD;
             or Mitomycin C, or for investigational drug within 5 half-lives of the treatment,&#xD;
             whichever is longer). Participation in non-interventional or observational studies is&#xD;
             allowed.&#xD;
&#xD;
          -  Patients with symptomatic brain metastases. Patients with asymptomatic brain&#xD;
             metastases can be included in the study if they are kept on stable doses of steroids&#xD;
             for a period of 1 month prior to study entry.&#xD;
&#xD;
          -  Patients with gastrointestinal abnormalities including inability to take oral&#xD;
             medications, malabsorption syndromes or other clinically significant gastrointestinal&#xD;
             abnormalities that may impair the absorption of the investigational medicinal product.&#xD;
&#xD;
          -  Pregnancy or lactation. Serum pregnancy test to be performed within 7 days prior to&#xD;
             study treatment start.&#xD;
&#xD;
          -  Patients with myocardial infarction within ≤ 12 months prior to study entry,&#xD;
             symptomatic congestive heart failure (New York Heart Association &gt; class II), unstable&#xD;
             angina pectoris, or unstable cardiac arrhythmia requiring medication.&#xD;
&#xD;
          -  Evidence of preexisting uncontrolled hypertension. Patients whose hypertension is&#xD;
             controlled by antihypertensive therapies are eligible.&#xD;
&#xD;
          -  Patients with known Hepatitis B or C or human immunodeficiency virus (HIV) infection&#xD;
&#xD;
          -  Evidence of any other medical conditions (such as psychiatric illness, infectious&#xD;
             diseases, physical examination or laboratory findings) that in the opinion of the&#xD;
             investigator may interfere with the planned treatment, affect patient compliance or&#xD;
             place the patient at high risk from treatment-related complications.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura Vidal, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clinic of Barcelona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Clínic</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>May 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>July 1, 2015</last_update_submitted>
  <last_update_submitted_qc>July 1, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02201823
org study id: ABT-C1-2013
secondary id: 2013-001293-17
secondary id: PEI 13-057
nct id: NCT02201823
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Ability Pharmaceuticals promotes a clinical trial to determine the adequate dose of a new
      drug, ABTL0812, that will be administered orally daily to patients with advanced solid
      tumors.
This is a phase I/Ib, unicenter, open-label and single-agent study. This study consists of
      two different parts, a dose escalation phase and an extension phase in patients with advanced
      solid tumors.

      ABTL0812 will be administered orally, daily, for 28 days (considered cycle 1). First endpoint
      is to determine the Maximum Tolerated Dose (MTD). MTD is defined as the highest dose at which
      no more than one in six patients experiences a ABTL0812 related Dose-Limiting Toxicity (DLT).
      DLT will be evaluated during the first treatment cycle.

      Dose escalation phase will be performed with an accelerated design of 3 + 3

      Once the 28 days cycle has finished, patients may continue receiving ABTL0812 on a daily
      continuous schedule if the patient is deemed to have clinical benefit from treatment,
      according to the treating physician. Treatment will continue until disease progression, onset
      of unacceptable drug toxicities, or patient/physician's request to discontinue.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To determine the maximum tolerated dose (MTD) of ABTL0812, administered orally on a daily continuous schedule in adult patients with advanced solid tumours
time frame: First 28 days of treatment
measure: To assess safety and tolerability of ABTL0812
time frame: First 28 days of treatment
measure: To evaluate preliminary antitumour activity of ABTL0812
time frame: After 6 months of treatment
measure: To determine the recommended Phase II dose
time frame: First 28 days of treatment
measure: To evaluate the pharmacokinetic (PK) profile of ABTL0812 in patients with advanced solid tumours
time frame: First 28 days of treatment
measure: To evaluate the pharmacodynamic (PD) profile of ABTL0812 exploring preliminary biomarkers of drug activity
time frame: First 28 days of treatment
arm group label: ABTL0812
arm group type: Experimental
description: ABTL0812 oral
intervention type: Drug
intervention name: ABTL0812
description: ABTL0812. Five cohorts and one extension phase.
arm group label: ABTL0812
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Laura Vidal, MD, PhD
role: Principal Investigator
affiliation: Hospital Clinic of Barcelona
facility: 
country: Spain
responsible party type: Sponsor