Source: https://www.cio-koeln-bonn.de/en/forschung/klinische-studien/cio-studienregister/studie/details/2620/
Timestamp: 2019-08-25 13:38:21
Document Index: 75895124

Matched Legal Cases: ['arts 1', 'art 2', 'arts 1', 'art 2', 'arts 1', 'art 2']

Studie ETS2101-004-Phase I - Center for Integrated Oncology Cologne Bonn
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
NCT02423239
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
Area under curve (AUC) of dexanabinol and (where applicable) combination chemotherapy [ Time Frame: Cycle 1 Day 1 and Day 8 pre-dose (0h); 1
3h (i.e. immediately prior to end infusion) post start of infusion; 5
30 min post-end infusion; 1
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
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
(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.
Major surgery within 4 weeks prior to Cycle 1, Day 1; bone marrow transplant within 100 days prior to Cycle 1, Day 1.
Active hepatitis B or C or other active liver disease (other than malignancy) (applies to all tumours types enrolled except HCC).
(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).
Adults patients defined by age ≥ 18 years.
Eastern Collaborative Oncology Group (ECOG) Performance Status (PS) or 0 or 1.
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.
(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).
Medizinische Klinik I (UKBonn)
Studienzentrum Bonn SZB - Studienzentrale
Studienzentrum Onkologische Gastroenterologie
Tel. +49 (0)228 287 16040,+49 228 / 287 - 15216
Studienzentrale-SZB@ukb.uni-bonn.de,Maria.Gonzalez-Carmona@ukbonn.de
Tel. +49 228/287-17017,+49 228 287 15216,+49 228 287 16045
Maria.Gonzalez-Carmona@ukb.ukbonn.de,christian.strassburg@ukbonn.de,Martin.Coenen@ukb.uni-bonn.de