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A Prospective, Randomised, Multicenter Phase II/III Clinical Trial to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT Versus Placebo


Phase 2/Phase 3
18 Years
79 Years
Not Enrolling
Both
Gastrointestinal Cancer, Prostate Cancer, Genital Neoplasms, Female

Thank you

Trial Information

A Prospective, Randomised, Multicenter Phase II/III Clinical Trial to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT Versus Placebo


The study will include patients with a variety of solid tumors (i.e. esophageal, colon,
pancreatic, bronchial, gastric, hepatocellular, gall bladder, prostate and gynaecological
carcinomas.)

The clinical benefit response - CBR, is an end point that provides a clinical measure for
symptom improvement in patients. The key evaluation parameters for CBR will be assessment of
pain, the ability to perform daily activities and weight change.


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 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 birth control methods

- Concurrent severe or uncontrolled medical disease

- Acute or chronic liver disease

- 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 this study

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Improvement in clinical benefit response

Outcome Time Frame:

Jan 2010

Safety Issue:

No

Principal Investigator

Joachim Drevs, PD Dr. Med

Investigator Role:

Principal Investigator

Investigator Affiliation:

Clinic SanaFontis

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

AMT/P2CA/001

NCT ID:

NCT00332280

Start Date:

May 2006

Completion Date:

March 2010

Related Keywords:

  • Gastrointestinal Cancer
  • Prostate Cancer
  • Genital Neoplasms, Female
  • solid tumors
  • clinical benefit
  • quality of life
  • esophageal cancer
  • colon cancer
  • pancreatic cancer
  • gastric cancer
  • liver cancer
  • gall bladder cancer
  • prostate cancer
  • gynecological cancer
  • lung cancer
  • Tumors of GI tract, prostate and gynaecological
  • Neoplasms
  • Genital Neoplasms, Female
  • Prostatic Neoplasms
  • Gastrointestinal Neoplasms

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