Advanced Gastrointestinal Cancer
Conditions
Brief summary
To evaluate the safety and tolerability of MSC\_apceth\_101.
Interventions
DRUGMSC_apceth_101
Sponsors
Apceth GmbH & Co. KG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with advanced or recurrent or metastatic gastrointestinal adenocarcinoma. * Premature or scheduled termination of standard therapy * Progressive disease as clinically assessed by the investigator * Max. tumour lesion ≤ 5 cm * Adequate organ function * Ability of patient to understand character and individual consequences of clinical trial * Age ≥ 18 years * Written informed consent must be available before any study specific procedure is performed
Exclusion criteria
* Patients with severe heart diseases * Clinical significant ischemic disease during the last 4 weeks before Visit 1 * Severe lung disease * Symptomatic peritoneal carcinomatosis * Symptomatic pleural or pericardial effusion * Serious uncontrolled acute infections less than 3 weeks before Visit 1 * Known dependency on alcohol or other drugs * Patients requiring corticoids in doses above the Cushing threshold * Known liver fibrosis or liver cirrhosis * Any concomitant severe disease which could compromise the objectives of this study in the judgment of the investigator * Female patient who is pregnant or breast feeding * Participation in another clinical trial or observation period, respectively, during the last 4 weeks prior to the first IMP dose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability as indicated by Common Toxicity Criteria (CTC-AE) of the National Cancer Institute | day 56 (+/- 7) in patient group 1 and day 29 (+/-3) in patient group 2 |
Countries
Germany
Outcome results
None listed