Study Stopped
Lack of efficacy
Study to Evaluate Progression Free Survival in Cancer Patients With Advanced Colorectal Carcinoma With AMT2003
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
2 other identifiers
interventional
67
1 country
1
Brief Summary
The purpose of the study is to evaluate efficacy and safety of AMT2003 in cancer patients with advanced colorectal carcinoma. The primary endpoint is progression free survival rate at 18 weeks after registration
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2006
Typical duration for phase_2
1 active site
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
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 29, 2006
CompletedFirst Posted
Study publicly available on registry
November 30, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedMarch 20, 2013
March 1, 2013
3.3 years
November 29, 2006
March 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival;at 18 weeks after registration
2010
Secondary Outcomes (5)
Best overall response rate (ORR, CR and PR) within 18 weeks after registration
2010
Progression Free survival time (PFS), over complete observation period
2010
Overall Survival (OS) time
2010
Quality of Life (EORTC QLQ-C30) and Performance Status (Karnofsky Index)
2010
Safety and Tolerability
2010
Study Arms (1)
AMT2003
EXPERIMENTALInterventions
Eligibility Criteria
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 of 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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinic SanaFontis
Freiburg im Breisgau, 79111, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joachim Drevs, PD Dr. med.
Clinic Sanafontis, Freiburg
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2006
First Posted
November 30, 2006
Study Start
October 1, 2006
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
March 20, 2013
Record last verified: 2013-03