NCT00332280

Brief Summary

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2006

Typical duration for phase_2

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 1, 2006

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 20, 2013

Status Verified

March 1, 2013

Enrollment Period

3.7 years

First QC Date

May 31, 2006

Last Update Submit

March 19, 2013

Conditions

Gastrointestinal CancerProstate CancerGenital Neoplasms, Female

Keywords

solid tumorsclinical benefitquality of lifeesophageal cancercolon cancerpancreatic cancergastric cancerliver cancergall bladder cancerprostate cancergynecological cancerlung cancerTumors of GI tract, prostate and gynaecological

Outcome Measures

Primary Outcomes (1)

  • Improvement in clinical benefit response

    Jan 2010

Secondary Outcomes (6)

  • Progression free survival

    Jan 2010

  • Overall survival

    Jan 2010

  • Overall response rate

    2010

  • Duration of response

    January 2010

  • Quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30])

    Jan 2010

  • +1 more secondary outcomes

Study Arms (1)

AMT2003

EXPERIMENTAL
Drug: AMT2003

Interventions

AMT2003DRUG
AMT2003

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Klinicki Centar Univerziteta Sarajevo - Klinika za gastroenterohepatologiju

Sarajevo, Bosnia and Herzegovina

Location

Clinic SanaFontis

Freiburg im Breisgau, 79111, Germany

Location

Related Links

MeSH Terms

Conditions

Gastrointestinal NeoplasmsProstatic NeoplasmsGenital Neoplasms, FemaleEsophageal NeoplasmsColonic NeoplasmsPancreatic NeoplasmsStomach NeoplasmsLiver NeoplasmsGallbladder NeoplasmsLung Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsHead and Neck NeoplasmsEsophageal DiseasesColorectal NeoplasmsIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesStomach DiseasesLiver DiseasesBiliary Tract NeoplasmsBiliary Tract DiseasesGallbladder DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Joachim Drevs, PD Dr. Med

    Clinic SanaFontis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2006

First Posted

June 1, 2006

Study Start

May 1, 2006

Primary Completion

January 1, 2010

Study Completion

March 1, 2010

Last Updated

March 20, 2013

Record last verified: 2013-03

Locations

DE(1)BO(1)