Treatment of Advanced Gastrointestinal Cancer in a Phase I/II Trial With Modified Autologous MSC_apceth_101

• Status: Terminated
• Trial end date: 2016-09-07
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and tolerability of MSC_apceth_101.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Apceth GmbH & Co. KG

Criteria

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