<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/NCT02216669</url>
  </required_header>
  <id_info>
    <org_study_id>08-2014</org_study_id>
    <nct_id>NCT02216669</nct_id>
  </id_info>
  <brief_title>Trial to Determine Optimal Phase II Dose of the Oral Dual CAIX Inhibitor/ Radiosensitizer</brief_title>
  <official_title>Phase I Trial to Determine Optimal Phase II Dose of the Oral Dual CAIX Inhibitor/ Radiosensitizer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht Radiation Oncology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maastricht Radiation Oncology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase I multicenter, open-label, dose-escalation study of DTP348. DTP 348 is an&#xD;
      oral dual drug with two mechanisms of action:&#xD;
&#xD;
        1. carbonic anhydrase IX inhibitor which acidifies the intracellular pH through the&#xD;
           sulfamide components&#xD;
&#xD;
        2. radio sensitizer of hypoxic cells through its 5-nitroimidazole moiety&#xD;
&#xD;
      The study will be conducted in 2 parts. The phase I trials will be on the standard 3+3 design&#xD;
      first as single agent then combined with radiotherapy:&#xD;
&#xD;
        1. A single agent dose-escalation phase in patients with solid tumours.&#xD;
&#xD;
        2. A dose-escalation phase in patients with HNSCC in combination with radiotherapy&#xD;
&#xD;
      The main objective is to determine the recommended phase II dose of DTP348 in combination&#xD;
      with radiotherapy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the single agent Phase I dose-escalation phase patients will be enrolled and assigned to a&#xD;
      dose level cohort. The starting dose will be 750 mg/m2, which equals to 1/10 of the human&#xD;
      equivalent dose of the LD10 of DTP348 in mice.&#xD;
&#xD;
      A &quot;3+3&quot; dose-escalation design will be used. The study will investigate sequential cohorts&#xD;
      consisting of 3-6 patients to be enrolled and treated at the applicable dose level. Planned&#xD;
      dose levels for subsequent cohorts are 1000, 1250 mg/m2 and steps of 250 mg/m2 thereafter.&#xD;
      There will be no intra-patient dose escalation. The treatment cycle in the dose-escalation&#xD;
      part of the study will consist of 7 weeks (reflecting the typical duration of the course of&#xD;
      radiotherapy). Patients will receive a continuous oral dose of DTP348 for 7 days per week.&#xD;
      Food intake is not allowed one hour before and after the intake of the study drug. After the&#xD;
      cycle of treatment, the patient will be followed until disease progression.&#xD;
&#xD;
      Blood samples for pharmacokinetic properties (PK) will be obtained on day 1 during the first&#xD;
      8 hours after oral administration and then daily on day 2, 3, 4 and 5, before the&#xD;
      administration of the daily dosage. A patient will stay on treatment until disease&#xD;
      progression, unacceptable toxicity, or discontinuation for any other reason. The dose&#xD;
      limiting toxicity (DLT) observation period for each dose level will be day 1 until the end of&#xD;
      week 7. Patients who do not complete the DLT observation period for other reasons than a DLT&#xD;
      will be replaced.&#xD;
&#xD;
      Toxicity that can be expected from DTP348 is related to the nitro-imidazole compound and&#xD;
      includes nausea, vomiting flushing, dizziness, skin rash, and neurotoxicity. Related to the&#xD;
      sulfamide component in the study drug, the side-effects may include nausea and vomiting. In&#xD;
      the experimental mice study, no toxicity was observed using a dose of 10 mg/kg i.v. 3 and up&#xD;
      to 400 mg/kg per os, which corresponds to the Human Equivalent Dose (HED) of 1.2 g/m2 of&#xD;
      nimorazole. Once the Maximum Tolerated Dose (MTD) of DTP348 has been established, 3&#xD;
      additional patients will be included in that dose-level. These patients will receive crushed&#xD;
      tablets and undergo blood sampling for PK to investigate whether the administration of&#xD;
      crushed tablets affects uptake and plasma levels of the study drug. This group of patients is&#xD;
      added because of the frequent occurrence of swallowing problems in the HNSCC patient&#xD;
      population and the use of tube feeding with the need of crushing tablets.&#xD;
&#xD;
      Once the MTD of DTP348 as single agent has been determined, the study will continue to the&#xD;
      combination phase: In the DTP348 in combination with radiotherapy dose-escalation phase,&#xD;
      again a 3+3 dose-escalation design will be used. The starting dose of DT348 will be the MTD&#xD;
      minus two dose levels. DTP348 will be given continuously 7 days a week, starting 2 weeks&#xD;
      before and during the whole course of radiation until and including the last day. The&#xD;
      rationale to start the study drug 2 weeks before the start of radiotherapy is to have a&#xD;
      similar design as in the phase II trial which will be performed following this study. The&#xD;
      drug will be given orally 1-2 hours before the daily delivery of radiotherapy. Food intake is&#xD;
      not allowed one hour before and after the intake of the study drug. The dose limiting&#xD;
      toxicity (DLT) observation period for each dose level will be from day 1 of combined therapy&#xD;
      until 4 weeks after the end of therapy. Patients who do not complete the DLT observation&#xD;
      period for other reasons than a DLT will be replaced.&#xD;
&#xD;
      The radiation treatment in the DTP348 in combination with radiotherapy dose-escalation phase&#xD;
      will be either conventional standard fractionated radiotherapy to a total dose of 70 Gy in 35&#xD;
      fractions over 7 weeks with a concomitant boost technique, 5 fractions a week or accelerated&#xD;
      radiotherapy delivering a total dose to 68-70 Gy in a shortened overall treatment time (5.5 -&#xD;
      6 weeks). The 95% isodose of the prescribed dose should encompass at least 99% of the&#xD;
      planning target and homogeneity will be according to ICRU guidelines. There is no restriction&#xD;
      of the treatment techniques that may be used: multiple static conformal or intensity&#xD;
      modulated beams, intensity modulated arc treatments, or robotic, non-isocentric treatments.&#xD;
      Dummy run on virtual patients will need to be performed before inclusion. Subsequently,&#xD;
      patients are allowed to be included in the trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No financial agreement&#xD;
  </why_stopped>
  <start_date type="Anticipated">March 2017</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</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>The maximum-tolerated dose (MTD) of DTP348 as single agent</measure>
    <time_frame>3 months</time_frame>
    <description>To assess the safety and tolerability of DTP348 when administered orally as single agent in patients with advanced solid tumours in order to determine the Maximum Tolerated Dose (MTD) in relation with the occurrence of a Dose Limiting Toxicity (DLT).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The maximum-tolerated dose (MTD) regimen of DTP348 as single agent in combination with radiotherapy</measure>
    <time_frame>3 months</time_frame>
    <description>To assess the safety and tolerability of DTP348 when administered orally in combination with radiotherapy in patients with HNSCC and to determine the Recommended Phase II Dose (RP2D) of this treatment combination.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma concentration of DTP348</measure>
    <time_frame>3 months</time_frame>
    <description>To characterise the Pharmacokinetic (PK) properties of DTP348 after oral administration as single agent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rate according to RECIST, version 1.1, DTP348 monotherapy</measure>
    <time_frame>3 months</time_frame>
    <description>To evaluate the preliminary efficacy of DTP348 monotherapy in terms of anti-tumour activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rate according to RECIST version 1.1, DTP348 in combination of radiotherapy</measure>
    <time_frame>3 months</time_frame>
    <description>To evaluate the preliminary efficacy of DTP348 in combination with radiotherapy in terms of anti-tumour activity in patients with HNSCC.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Solid Tumors</condition>
  <condition>Head and Neck Neoplasms</condition>
  <arm_group>
    <arm_group_label>DTP348</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive a continuous oral dose of DTP348 for 7 days per week for 7 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DTP348</intervention_name>
    <description>Patients will receive a continuous oral dose of DTP348 for 7 days per week for 7 weeks</description>
    <arm_group_label>DTP348</arm_group_label>
    <other_name>2-(2-methyl-5-nitro-1H-imidazol-1-yl)ethylsulfamide</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with histologically or cytologically confirmed solid malignancy that is&#xD;
             metastatic or unresectable and for which standard curative measures or other therapy&#xD;
             that may provide clinical benefit do not exist or are no longer effective.&#xD;
&#xD;
          -  Age 18 year or older&#xD;
&#xD;
          -  Performance status, WHO = 0 - 2&#xD;
&#xD;
          -  Subject must have adequate bone marrow, renal and hepatic function per local&#xD;
             laboratory reference rage as follows:&#xD;
&#xD;
        Bone marrow: absolute neutrophil count (ANC) &gt;/= 1,500/ul; platelets &gt;/= 100,000/mm3&#xD;
        (independent of platelet transfusion, within 3 months prior to starting study drug);&#xD;
        haemoglobin &gt;/= 9.0 g/dL&#xD;
&#xD;
        Renal function: serum creatinine &lt;/= 2.0 mg/dL or calculated creatinine clearance &gt;/= 50&#xD;
        mL/min&#xD;
&#xD;
        Hepatic function and enzymes: AST and ALT &lt;/= 2.5 x the upper limit of normal (ULN) of&#xD;
        institution's normal range. Bilirubin &lt;/=1.5 x INL.&#xD;
&#xD;
        Subjects with liver metastases may have an AST and ALT of &lt;/= 5.0 x ULN&#xD;
&#xD;
          -  Measurable disease (RECIST, version 1.1)&#xD;
&#xD;
          -  Subjects with known brain metastases must have clinically controlled neurologic&#xD;
             symptoms, defined as surgical excision and or radiation therapy followed by 21 days of&#xD;
             stable neurologic function and no evidence of CNS disease progression as determined by&#xD;
             comparing a computed tomography (CT) scan or magnetic resonance imaging (MRI) scan&#xD;
             performed during screening to a prior scan performed at least 4 weeks earlier and&#xD;
             provided that the subject is asymptomatic, has no evidence of cavitation or&#xD;
             haemorrhage and is on a stable dose of dexamethasone.&#xD;
&#xD;
          -  Females must have negative results for pregnancy tests performed:&#xD;
&#xD;
        At screening on a serum sample obtained within 7 days prior to initial study drug&#xD;
        administration, and Prior to dosing on a urine pregnancy test will be obtained prior to&#xD;
        study drug administration (cycle 1, day 1).&#xD;
&#xD;
          -  No breast feeding.&#xD;
&#xD;
          -  If female, subject must be either postmenopausal for at least 2 years, surgically&#xD;
             sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or&#xD;
             practicing at least one of the following methods of birth control:&#xD;
&#xD;
        Total abstinence from sexual intercourse as the preferred life style of the subject,&#xD;
        periodic abstinence is not acceptable; Vasectomized partner; Hormonal contraceptives (oral,&#xD;
        parenteral or transdermal) for at least 3 months prior to study drug administration (if the&#xD;
        subject is currently using a hormonal contraceptive, she should also use a barrier method&#xD;
        during the study and for 1 months after study completion); Intrauterine device (IUD);&#xD;
        Double barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with&#xD;
        spermicidal jellies or creams);&#xD;
&#xD;
        - If male, subject must be surgically sterile or practicing at least 1 of the following&#xD;
        methods of contraception and refrain from sperm donation, from initial drug administration&#xD;
        until 90 days after the last dose of study drug: Partner(s) using an IUD; Partner(s) using&#xD;
        hormonal contraceptives (oral, vaginal, parenteral or transdermal); Subject and/or&#xD;
        partner(s) using double-barrier method (condoms, contraceptive sponge, diaphragm, or&#xD;
        vaginal ring with spermicidal jellies or creams).&#xD;
&#xD;
        Total abstinence from sexual intercourse as the preferred life style of the subject;&#xD;
        periodic abstinence is not acceptable.&#xD;
&#xD;
          -  Ability to swallow and take oral medication. Patients that are dependent on a feeding&#xD;
             tube can only be included in the study when entered in the last cohort, in which the&#xD;
             PK of crushed study medication is the object of study.&#xD;
&#xD;
          -  Absence of any psychological, familial, sociological or geographical condition&#xD;
             potentially hampering compliance with the study protocol and follow-up schedule&#xD;
&#xD;
          -  Willing and able to undergo blood sampling for pharmacokinetics&#xD;
&#xD;
          -  Must voluntarily sign and date each informed consent, approved by an independent&#xD;
             Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of&#xD;
             any screening or study-specific procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If the subject has clinically significant and uncontrolled major medical condition(s)&#xD;
             including but not limited to:&#xD;
&#xD;
        Uncontrolled seizure disorder, including focal or generalised seizure within the last 12&#xD;
        months; Uncontrolled nausea/vomiting/diarrhea; Active uncontrolled infection, including HIV&#xD;
        and hepatitis (HBV, HCV) Symptomatic congestive heart failure, irreversible cardiac&#xD;
        arrhythmias, acute or subacute coronary syndromes within the last year.&#xD;
&#xD;
        Psychiatric illness/social situation that would limit compliance with study requirements&#xD;
        Any medical condition, with the opinion of the study investigator, places the subject at an&#xD;
        unacceptably high risk for toxicities.&#xD;
&#xD;
          -  Female subject is pregnant or breastfeeding.&#xD;
&#xD;
          -  Subject has received any of the following anti-cancer therapies 21 days prior to the&#xD;
             first dose of study drug:&#xD;
&#xD;
        Chemotherapy, immunotherapy, radiotherapy.&#xD;
&#xD;
        Any investigational therapy, including targeted small molecule agents. With the following&#xD;
        exceptions:&#xD;
&#xD;
          -  Hormonal anticancer therapy must be stopped 7 days before starting day 1 of cycle 1&#xD;
             (C1D1)&#xD;
&#xD;
          -  Hormones for hypothyroidism, estrogen replacement therapy (ERT) or agonists required&#xD;
             or suppress serum testosterone or estrogen levels (e.g. LHRH, GnRH, etc) for subjects&#xD;
             with prostate, breast and ovarian cancer if on a stable dose for 21 days prior to the&#xD;
             first dose of study drug.&#xD;
&#xD;
          -  Subject has received a biological agent for anti-neoplastic intent within 30 days&#xD;
             prior to the first dose of study drug.&#xD;
&#xD;
          -  Subject who requires parenteral nutrition, tube feeding or has evidence of partial&#xD;
             bowel obstruction or perforation within 28 days prior to study drug administration.&#xD;
&#xD;
          -  The subject has had another active malignancy within the past 3 years except for any&#xD;
             cancer in situ that the Principal Investigator considers to be cured.&#xD;
&#xD;
          -  In the opinion of the investigator, the subject is an unsuitable candidate to receive&#xD;
             DTP348.&#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>Frank Hoebers, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastro Clinic, The Netherlands</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maastro Clinic</name>
      <address>
        <city>Maastricht</city>
        <state>Limburg</state>
        <zip>6229 ET</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>March 1, 2017</last_update_submitted>
  <last_update_submitted_qc>March 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Solid tumors</keyword>
  <keyword>Head and Neck Neoplasms</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Imidazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02216669
org study id: 08-2014
nct id: NCT02216669
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a Phase I multicenter, open-label, dose-escalation study of DTP348. DTP 348 is an
      oral dual drug with two mechanisms of action:

        1. carbonic anhydrase IX inhibitor which acidifies the intracellular pH through the
           sulfamide components

        2. radio sensitizer of hypoxic cells through its 5-nitroimidazole moiety

      The study will be conducted in 2 parts. The phase I trials will be on the standard 3+3 design
      first as single agent then combined with radiotherapy:

        1. A single agent dose-escalation phase in patients with solid tumours.

        2. A dose-escalation phase in patients with HNSCC in combination with radiotherapy

      The main objective is to determine the recommended phase II dose of DTP348 in combination
      with radiotherapy
In the single agent Phase I dose-escalation phase patients will be enrolled and assigned to a
      dose level cohort. The starting dose will be 750 mg/m2, which equals to 1/10 of the human
      equivalent dose of the LD10 of DTP348 in mice.

      A "3+3" dose-escalation design will be used. The study will investigate sequential cohorts
      consisting of 3-6 patients to be enrolled and treated at the applicable dose level. Planned
      dose levels for subsequent cohorts are 1000, 1250 mg/m2 and steps of 250 mg/m2 thereafter.
      There will be no intra-patient dose escalation. The treatment cycle in the dose-escalation
      part of the study will consist of 7 weeks (reflecting the typical duration of the course of
      radiotherapy). Patients will receive a continuous oral dose of DTP348 for 7 days per week.
      Food intake is not allowed one hour before and after the intake of the study drug. After the
      cycle of treatment, the patient will be followed until disease progression.

      Blood samples for pharmacokinetic properties (PK) will be obtained on day 1 during the first
      8 hours after oral administration and then daily on day 2, 3, 4 and 5, before the
      administration of the daily dosage. A patient will stay on treatment until disease
      progression, unacceptable toxicity, or discontinuation for any other reason. The dose
      limiting toxicity (DLT) observation period for each dose level will be day 1 until the end of
      week 7. Patients who do not complete the DLT observation period for other reasons than a DLT
      will be replaced.

      Toxicity that can be expected from DTP348 is related to the nitro-imidazole compound and
      includes nausea, vomiting flushing, dizziness, skin rash, and neurotoxicity. Related to the
      sulfamide component in the study drug, the side-effects may include nausea and vomiting. In
      the experimental mice study, no toxicity was observed using a dose of 10 mg/kg i.v. 3 and up
      to 400 mg/kg per os, which corresponds to the Human Equivalent Dose (HED) of 1.2 g/m2 of
      nimorazole. Once the Maximum Tolerated Dose (MTD) of DTP348 has been established, 3
      additional patients will be included in that dose-level. These patients will receive crushed
      tablets and undergo blood sampling for PK to investigate whether the administration of
      crushed tablets affects uptake and plasma levels of the study drug. This group of patients is
      added because of the frequent occurrence of swallowing problems in the HNSCC patient
      population and the use of tube feeding with the need of crushing tablets.

      Once the MTD of DTP348 as single agent has been determined, the study will continue to the
      combination phase: In the DTP348 in combination with radiotherapy dose-escalation phase,
      again a 3+3 dose-escalation design will be used. The starting dose of DT348 will be the MTD
      minus two dose levels. DTP348 will be given continuously 7 days a week, starting 2 weeks
      before and during the whole course of radiation until and including the last day. The
      rationale to start the study drug 2 weeks before the start of radiotherapy is to have a
      similar design as in the phase II trial which will be performed following this study. The
      drug will be given orally 1-2 hours before the daily delivery of radiotherapy. Food intake is
      not allowed one hour before and after the intake of the study drug. The dose limiting
      toxicity (DLT) observation period for each dose level will be from day 1 of combined therapy
      until 4 weeks after the end of therapy. Patients who do not complete the DLT observation
      period for other reasons than a DLT will be replaced.

      The radiation treatment in the DTP348 in combination with radiotherapy dose-escalation phase
      will be either conventional standard fractionated radiotherapy to a total dose of 70 Gy in 35
      fractions over 7 weeks with a concomitant boost technique, 5 fractions a week or accelerated
      radiotherapy delivering a total dose to 68-70 Gy in a shortened overall treatment time (5.5 -
      6 weeks). The 95% isodose of the prescribed dose should encompass at least 99% of the
      planning target and homogeneity will be according to ICRU guidelines. There is no restriction
      of the treatment techniques that may be used: multiple static conformal or intensity
      modulated beams, intensity modulated arc treatments, or robotic, non-isocentric treatments.
      Dummy run on virtual patients will need to be performed before inclusion. Subsequently,
      patients are allowed to be included in the trial.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The maximum-tolerated dose (MTD) of DTP348 as single agent
time frame: 3 months
description: To assess the safety and tolerability of DTP348 when administered orally as single agent in patients with advanced solid tumours in order to determine the Maximum Tolerated Dose (MTD) in relation with the occurrence of a Dose Limiting Toxicity (DLT).
measure: The maximum-tolerated dose (MTD) regimen of DTP348 as single agent in combination with radiotherapy
time frame: 3 months
description: To assess the safety and tolerability of DTP348 when administered orally in combination with radiotherapy in patients with HNSCC and to determine the Recommended Phase II Dose (RP2D) of this treatment combination.
measure: Plasma concentration of DTP348
time frame: 3 months
description: To characterise the Pharmacokinetic (PK) properties of DTP348 after oral administration as single agent
measure: Response rate according to RECIST, version 1.1, DTP348 monotherapy
time frame: 3 months
description: To evaluate the preliminary efficacy of DTP348 monotherapy in terms of anti-tumour activity
measure: Response rate according to RECIST version 1.1, DTP348 in combination of radiotherapy
time frame: 3 months
description: To evaluate the preliminary efficacy of DTP348 in combination with radiotherapy in terms of anti-tumour activity in patients with HNSCC.
arm group label: DTP348
arm group type: Experimental
description: Patients will receive a continuous oral dose of DTP348 for 7 days per week for 7 weeks
intervention type: Drug
intervention name: DTP348
description: Patients will receive a continuous oral dose of DTP348 for 7 days per week for 7 weeks
arm group label: DTP348
other name: 2-(2-methyl-5-nitro-1H-imidazol-1-yl)ethylsulfamide
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Frank Hoebers, Dr.
role: Principal Investigator
affiliation: Maastro Clinic, The Netherlands
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
mesh term: Imidazole
sharing ipd: No