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

NCT ID: NCT02008539

Last Updated: 2017-03-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-09-07

Brief Summary

To evaluate the safety and tolerability of MSC_apceth_101.

Conditions

Advanced Gastrointestinal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment arm

Group Type: EXPERIMENTAL

MSC_apceth_101

Intervention Type: DRUG

Interventions

MSC_apceth_101

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Apceth GmbH & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Munich

Munich, , Germany

Countries

Germany

Other Identifiers

MSC_apceth_101/1

Identifier Type: -

Identifier Source: org_study_id