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

Phase 1

Terminated

• Conditions: Advanced Gastrointestinal Cancer
• Interventions: Drug: MSC_apceth_101

• Registration Number: NCT02008539
• Lead Sponsor: Apceth GmbH & Co. KG

Brief Summary

To evaluate the safety and tolerability of MSC_apceth_101.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-28
• Study First Submitted QC: 2013-12-06
• Study First Posted: 2013-12-11
• Primary Completion: 2016-09-07
• Study Completion: 2016-09-07
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-23
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment arm	MSC_apceth_101	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Munich; 🇩🇪 Munich, Germany