A Phase 1 Dose Escalation Trial of ASG-5ME in Pancreatic or Gastric Adenocarcinoma
NCT ID: NCT01166490
Last Updated: 2013-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
51 participants
INTERVENTIONAL
2010-07-31
2013-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
ASG-5ME
ASG-5ME
0.3-3.0 mg/kg IV on Days 1, 8, and 15 of 28-day cycles
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ASG-5ME
0.3-3.0 mg/kg IV on Days 1, 8, and 15 of 28-day cycles
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Agensys, Inc.
INDUSTRY
Seagen Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nancy Whiting, PharmD, BCOP
Role: STUDY_DIRECTOR
Seagen Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
TGen Clinical Research Service at Scottsdale Healthcare
Scottsdale, Arizona, United States
University of California at San Francisco
San Francisco, California, United States
University of Chicago
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Texas Oncology - Baylor Sammons Cancer Center
Dallas, Texas, United States
Texas Oncology - Tyler
Tyler, Texas, United States
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ASG5ME-002
Identifier Type: -
Identifier Source: org_study_id