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

A

Apceth

Status and phase

Terminated
Phase 2
Phase 1

Conditions

Advanced Gastrointestinal Cancer

Treatments

Drug: MSC_apceth_101

Study type

Interventional

Funder types

Industry

Identifiers

NCT02008539
MSC_apceth_101/1

Details and patient eligibility

About

To evaluate the safety and tolerability of MSC_apceth_101.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 1 patient group

treatment arm
Experimental group
Treatment:
Drug: MSC_apceth_101

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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