last updated at 22.11.2019

ETS2101-004-Phase I

A Phase 1b, Study to Assess the Safety and Anti-tumour Activity of Dexanabinol Monotherapy and Dexanabinol in Combination with Chemotherapy in Patients with Advanced Tumours

Status: Aktiv (Rekrutierung geschlossen)

ISRCTN EudraCT Clinicaltrials.gov DRKS
NCT02423239

Diagnose

  • Karzinom
  • Hepatozellulär
  • Pankreaskarzinom (Bauchspeicheldrüsenkrebs)

Studienziel / Fragestellung

Primäres Prüfziel
    • Maximum Tolerated Dose (MTD) of dexanabinol given in combination with standard chemotherapies
    • Number of adverse events (AEs) in patients receiving dexanabinol monotherapy
    • Number of adverse events (AEs) in patients receiving dexanabinol in combination with standard chemotherapies
Sekundäre Prüfziele
    • Area under curve (AUC) of dexanabinol and (where applicable) combination chemotherapy [ Time Frame: Cycle 1 Day 1 and Day 8 pre-dose (0h); 1
    • 2
    • 3h (i.e. immediately prior to end infusion) post start of infusion; 5
    • 10
    • 15
    • 30 min post-end infusion; 1
    • 2
    • 3
    • 4
    • 6
    • 8
    • 10 and 24h post-end infusion; day 15 immediately prior to and at end of IMP infusion ]
    • Maximum concentration (Cmax) of dexanabinol and (where applicable) combination chemotherapy [ Time Frame: Cycle 1 Day 1 and Day 8 pre-dose (0h); 1
    • 2
    • 3h (i.e. immediately prior to end infusion) post start of infusion; 5
    • 10
    • 15
    • 30 min post-end infusion; 1
    • 2
    • 3
    • 4
    • 6
    • 8
    • 10 and 24h post-end infusion day 15 immediately prior to and at end of IMP infusion
    • Minimum concentration (Cmin) of dexanabinol and (where applicable) combination chemotherapy [ Time Frame: Cycle 1 Day 1 and Day 8 pre-dose (0h); 1
    • 2
    • 3h (i.e. immediately prior to end infusion) post start of infusion; 5
    • 10
    • 15
    • 30 min post-end infusion; 1
    • 2
    • 3
    • 4
    • 6
    • 8
    • 10 and 24h post-end infusion day 15 immediately prior to and at end of IMP infusion

Patientenmerkmale

Alter

18-99

Ausschlusskriterien

     

  1. Patient is pregnant or breast feeding.
  2. History of clinically significant cardiac condition, including ischemic cardiac event, myocardial infarction or unstable cardiac disease within 3 months of Cycle 1, Day 1.
  3. Known brain metastases.
  4. (i) Parts 1 and 2b (dexanabinol combination): Prior systemic chemotherapy.

    (ii) Part 2a (dexanabinol monotherapy): Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to Cycle 1, Day 1 for solid tumours (with the exception of hydroxyurea, which must be discontinued at least 24 hours prior to Cycle 1, Day 1). Localised palliative radiotherapy is permitted for symptom control.

  5. Major surgery within 4 weeks prior to Cycle 1, Day 1; bone marrow transplant within 100 days prior to Cycle 1, Day 1.
  6. Known human immunodeficiency virus positivity.
  7. Active hepatitis B or C or other active liver disease (other than malignancy) (applies to all tumours types enrolled except HCC).
  8. Use of any investigational agents within 4 weeks of Cycle 1, Day 1.
  9. Any active, clinically significant, viral, bacterial, or systemic fungal infection within 4 weeks prior to Cycle 1, Day 1.
  10. History of significant chronic or recurrent infections requiring treatment or any uncontrolled intercurrent illness that would jeopardize patient safety, interfere with the objectives of the protocol, or limit patient compliance with study requirements, as determined by the Investigator.
  11.  

Einschlusskriterien

     

  1. (i) Parts 1 and 2b (dexanabinol combination): Patients with selected histologically, cytologically or radiologically confirmed tumours that are advanced, metastatic and/or progressive, and eligible for 1st line chemotherapy.

       

    • HCC only: patient with Child-Pugh A stage.
    • Pancreatic cancer only: patients diagnosed with adenocarcinoma (i.e. pancreatic cancer patients with islet cell neuroplasms are excluded).
    •  

    (ii) Part 2a (dexanabinol monotherapy): Patients with histologically, cytologically or radioloigically confirmed tumours that are advanced, metastatic and/or progressive, for whom there is no effective standard therapy available.

       

    • Pancreatic cancer only: patients diagnosed with adenocarinoma (i.e. pancreatic cancer patients with islet cell neuroplasms are excluded).
    •  

  2. Adults patients defined by age ≥ 18 years.
  3. Eastern Collaborative Oncology Group (ECOG) Performance Status (PS) or 0 or 1.
  4. Any acute or chronic adverse effects of prior chemotherapy or radiotherapy have resolved to < Grade 2 as determined by CTCAE v4.03 criteria, with the exception of alopecia.
  5. (i) Parts 1 and 2b: Measureable disease assessed by appropriate method for each tumour type e.g. RECIST 1.1 (Eisenhauer, et al. 2009).

    (ii) Part 2a: Evaluable disease, either measureable on imaging, or with informative tumour marker(s).

  6.  

Studiendesign

  • Dreiarmig
  • Multizentrisch
  • Phase I

Intervention

Dokumente (passwortgeschützt)

Zuständigkeiten Gesamtstudie

Sponsor

  • e-Therapeutics PLC

Prüfzentrum 1

 

  • Medizinische Klinik I (UKBonn)

Studienbüro

  • Studienzentrum Bonn SZB - Studienzentrale
  • Studienzentrum Onkologische Gastroenterologie

Ärztliches Mitglied der Prüfgruppe

  • Dr. Christoph Coch
  • PD Dr. med. Maria Gonzalez-Carmona

Studienkontakt im Prüfzentrum

  • PD Dr. med. Maria Gonzalez-Carmona
  • Prof. Dr. med. Christian Strassburg
  • Dr. med. Martin Coenen

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