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

NCT02008539 | Terminated Phase 1 DMC

• 1 other identifier: MSC_apceth_101/1
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and tolerability of MSC\_apceth\_101.

Conditions

Advanced Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

treatment arm

EXPERIMENTAL

Drug: MSC_apceth_101

Interventions

MSC_apceth_101 DRUG

treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Apceth GmbH & Co. KG: lead

Study Sites (1)

University Hospital Munich

Munich, 81377, Germany

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: December 11, 2013
• Study Start: October 1, 2013
• Primary Completion: September 7, 2016
• Study Completion: September 7, 2016
• Last Updated: March 27, 2017

Record last verified: 2017-03

Locations

DE (1)