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A Prospective, Open, Single-arm, Multicenter Phase II Clinical Trial to Evaluate the Tumour Response and Safety in Patients With Advanced Primary Hepatocellular Carcinoma Treated With AMT2003


Phase 2
18 Years
79 Years
Not Enrolling
Both
Hepatocellular Carcinoma

Thank you

Trial Information

A Prospective, Open, Single-arm, Multicenter Phase II Clinical Trial to Evaluate the Tumour Response and Safety in Patients With Advanced Primary Hepatocellular Carcinoma Treated With AMT2003


The study will include patients with advanced primary hepatocellular carcinoma refractory to
standard therapy or for which no effective standard therapy exists.

The best overall response rate is the best response recorded from the start of treatment
until disease progression / recurrence.


Inclusion Criteria:



- Cancer confirmed by histology or cytology

- At least one measurable lesion

- Advanced disease refractory to standard therapy or for which no standard therapy
exists

- Life expectancy of at least 3 months

Exclusion Criteria:

- Known secondary neoplasia or central nervous system (CNS) metastases; acute or
chronic leukemia, lymphoma or multiple myeloma

- Body weight below 45 kg

- Female patients who are pregnant or breast feeding or adults of reproductive
potential not employing effective method of birth control

- Confirmed diagnosis of HIV

- Insulin dependent diabetes mellitus / abnormal glucose tolerance test (GTT) / latent
diabetes mellitus type I or II

- Chemotherapy or radiotherapy less than 4 weeks prior to entry

- Surgery less than 2 weeks prior to entry (or not recovered from effects of surgery)

- Participation in a clinical trial less than 30 days prior to entry into study

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Best overall tumour response according to RECIST; within 20 weeks after registration; confirmation 6 +/- weeks later

Outcome Time Frame:

March 2010

Safety Issue:

No

Principal Investigator

Hubert Blum, Prof. Dr. med. Dr. h. c.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Freiburg

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

AMT/P2GI/001 Part I

NCT ID:

NCT00405873

Start Date:

March 2007

Completion Date:

March 2010

Related Keywords:

  • Hepatocellular Carcinoma
  • Primary hepatocellular carcinoma
  • Liver cancer
  • Tumour response
  • Quality of life
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

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