- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01166490
A Phase 1 Dose Escalation Trial of ASG-5ME in Pancreatic or Gastric Adenocarcinoma
August 23, 2013 updated by: Seagen Inc.
A Phase 1, Open-Label, Dose Escalation Study of ASG-5ME in Patients With Pancreatic or Gastric Adenocarcinoma
This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety and tolerability of ASG-5ME and identify the maximum tolerated dose in patients with pathologically confirmed metastatic pancreatic adenocarcinoma, and to evaluate safety and tolerability in patients with relapsed or refractory gastric adenocarcinoma.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259
- TGEN Clinical Research Service at Scottsdale Healthcare
-
-
California
-
San Francisco, California, United States, 94115
- University of California at San Francisco
-
-
Illinois
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Chicago, Illinois, United States, 60637-1470
- University of Chicago
-
-
Massachusetts
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Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
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Texas
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Dallas, Texas, United States, 75246
- Texas Oncology - Baylor Sammons Cancer Center
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Tyler, Texas, United States, 75702
- Texas Oncology - Tyler
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Washington
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Seattle, Washington, United States, 98109-1023
- Seattle Cancer Care Alliance / University of Washington
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Pathologically confirmed metastatic pancreatic adenocarcinoma or pathologically confirmed AGS-5-positive gastric or gastric esophageal junction adenocarcinoma
- Measurable disease (at least one nonresectable, non-nodal lesion greater than or equal to 10 mm in longest diameter or nodal lesion greater than or equal to 15 mm in shortest axis)
- ECOG performance status of 0 or 1
- May be untreated or have previously received treatment for pancreatic adenocarcinoma or must have relapsed or refractory disease following 1 prior systemic therapy for metastatic gastric adenocarcinoma. For patients who have previously received treatment, it must be at least 2 weeks since the last systemic therapy or radiation, and at least 4 weeks since treatment with any monoclonal antibody (other than bevacizumab).
Exclusion Criteria:
- Evidence or history of central nervous system metastases
- History of another primary malignancy that has not been in remission for at least 3 years
- Documented history of a cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with NYHA Class III-IV within 6 months prior
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
ASG-5ME
|
0.3-3.0
mg/kg IV on Days 1, 8, and 15 of 28-day cycles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of adverse events and laboratory abnormalities
Time Frame: Through 1 month after last dose
|
Through 1 month after last dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Best clinical response
Time Frame: Every 2 months
|
Every 2 months
|
Overall and progression-free survival
Time Frame: Every month until death or study closure
|
Every month until death or study closure
|
Concentrations of ASG-5ME and metabolites in blood
Time Frame: Through 1 month after last dose
|
Through 1 month after last dose
|
Incidence of antitherapeutic antibodies in blood
Time Frame: Through 1 month after last dose
|
Through 1 month after last dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Nancy Whiting, PharmD, BCOP, Seagen Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
July 19, 2010
First Submitted That Met QC Criteria
July 19, 2010
First Posted (Estimate)
July 21, 2010
Study Record Updates
Last Update Posted (Estimate)
August 27, 2013
Last Update Submitted That Met QC Criteria
August 23, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Neoplasms
- Stomach Neoplasms
- Adenocarcinoma
- Pancreatic Neoplasms
Other Study ID Numbers
- ASG5ME-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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