Study to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT2003 Versus Placebo
This study has been terminated.
(Lack of efficacy. Stopped at first interim evaluation point)
Sponsor:
Auron Healthcare GmbH
Information provided by (Responsible Party):
Auron Healthcare GmbH
ClinicalTrials.gov Identifier:
NCT00332280
First received: May 31, 2006
Last updated: March 19, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of the study is to evaluate the efficacy and the safety of AMT2003 in cancer patients with advanced disease.
The primary evaluation criterion is clinical benefit response.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Cancer Prostate Cancer Genital Neoplasms, Female |
Drug: AMT2003 |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Auron Healthcare GmbH:
Primary Outcome Measures:
- Improvement in clinical benefit response [ Time Frame: Jan 2010 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression free survival [ Time Frame: Jan 2010 ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Jan 2010 ] [ Designated as safety issue: No ]
- Overall response rate [ Time Frame: 2010 ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: January 2010 ] [ Designated as safety issue: No ]
- Quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]) [ Time Frame: Jan 2010 ] [ Designated as safety issue: No ]
- Safety and tolerability [ Time Frame: Jan 2010 ] [ Designated as safety issue: Yes ]
| Enrollment: | 67 |
| Study Start Date: | May 2006 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: AMT2003 | Drug: AMT2003 |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00332280
Locations
| Bosnia and Herzegovina | |
| Klinicki Centar Univerziteta Sarajevo - Klinika za gastroenterohepatologiju | |
| Sarajevo, Bosnia and Herzegovina | |
| Germany | |
| Clinic SanaFontis | |
| Freiburg im Breisgau, Germany, 79111 | |
Sponsors and Collaborators
Auron Healthcare GmbH
Investigators
| Principal Investigator: | Joachim Drevs, PD Dr. Med | Clinic SanaFontis |
More Information
Additional Information:
No publications provided
| Responsible Party: | Auron Healthcare GmbH |
| ClinicalTrials.gov Identifier: | NCT00332280 History of Changes |
| Other Study ID Numbers: | AMT/P2CA/001, LC003AURON2005 |
| Study First Received: | May 31, 2006 |
| Last Updated: | March 19, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Auron Healthcare GmbH:
|
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 |
Additional relevant MeSH terms:
|
Neoplasms Genital Neoplasms, Female Prostatic Neoplasms Gastrointestinal Neoplasms Urogenital Neoplasms Neoplasms by Site |
Genital Neoplasms, Male Genital Diseases, Male Prostatic Diseases Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases |
ClinicalTrials.gov processed this record on May 22, 2013