A Phase 1 Dose Escalation Trial of ASG-5ME in Pancreatic or Gastric Adenocarcinoma

Completed · Phase 1

Conditions studied: Gastric Neoplasms, Pancreatic Neoplasms

In brief

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.

Key facts

Study ID

NCT01166490

Run by

Seagen Inc.

People needed

51

Starts

2010-07-01

Expected to finish

2013-07-01

Last updated by the study team

2013-08-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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