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

Advanced Gastrointestinal Cancer Clinical Trial

— TREAT-ME 1  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02008539
• Other study ID #: MSC_apceth_101/1
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: October 28, 2013
• Last updated: March 23, 2017
• Start date: October 2013
• Est. completion date: September 7, 2016

Study information

• Verified date: March 2017
• Source: Apceth GmbH & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and tolerability of MSC_apceth_101.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: September 7, 2016
• Est. primary completion date: September 7, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

Drug:
• MSC_apceth_101

Locations

Country	Name	City	State
Germany	University Hospital Munich	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Apceth GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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