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A Prospective, Open, Single-Arm, Multicenter Phase II Clinical Trial to Evaluate the Progression Free Survival and Safety in Patients With Advanced Colorectal Carcinoma Treated With AMT2003


Phase 2/Phase 3
18 Years
79 Years
Not Enrolling
Both
Colorectal Carcinoma

Thank you

Trial Information

A Prospective, Open, Single-Arm, Multicenter Phase II Clinical Trial to Evaluate the Progression Free Survival and Safety in Patients With Advanced Colorectal Carcinoma Treated With AMT2003


The study will include patients with advanced colorectal carcinoma that is refractory to
standard therapy or for which no effective standard therapy exists. Eligible patients must
have had at least second-line chemotherapy.


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 in the 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:

Progression free survival;at 18 weeks after registration

Outcome Time Frame:

2010

Safety Issue:

No

Principal Investigator

Joachim Drevs, PD Dr. med.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Clinic Sanafontis, Freiburg

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

AMT/P2GI/001 Part III

NCT ID:

NCT00405561

Start Date:

October 2006

Completion Date:

January 2010

Related Keywords:

  • Colorectal Carcinoma
  • Advanced Colorectal Carcinoma
  • Carcinoma
  • Colorectal Neoplasms

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