Treatment of Advanced Gastrointestinal Cancer in a Phase I/II Trial With Modified Autologous MSC_apceth_101 (TREAT-ME 1)

To evaluate the safety and tolerability of MSC_apceth_101.

Study Overview

• Status: Terminated
• Conditions: Advanced Gastrointestinal Cancer
• Intervention / Treatment: Drug: MSC_apceth_101

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 81377
    • University Hospital Munich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment arm	Drug: MSC_apceth_101

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Apceth GmbH & Co. KG

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): September 7, 2016
• Study Completion (Actual): September 7, 2016

Study Registration Dates

• First Submitted: October 28, 2013
• First Submitted That Met QC Criteria: December 6, 2013
• First Posted (Estimate): December 11, 2013

Study Record Updates

• Last Update Posted (Actual): March 27, 2017
• Last Update Submitted That Met QC Criteria: March 23, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms
• Other Study ID Numbers: MSC_apceth_101/1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No