Status:
COMPLETED
A Phase 1 Dose Escalation Trial of ASG-5ME in Pancreatic or Gastric Adenocarcinoma
Lead Sponsor:
Seagen Inc.
Collaborating Sponsors:
Agensys, Inc.
Conditions:
Gastric Neoplasms
Pancreatic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 metas...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01166490
Start Date
July 1 2010
End Date
July 1 2013
Last Update
August 27 2013
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
TGen Clinical Research Service at Scottsdale Healthcare
Scottsdale, Arizona, United States, 85259
2
University of California at San Francisco
San Francisco, California, United States, 94115
3
University of Chicago
Chicago, Illinois, United States, 60637-1470
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215