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



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/27/2013
Start Date:July 2010
End Date:October 2013
Contact:Terri Lowe
Email:clinicaltrials@seagen.com
Phone:866-333-7436

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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.


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
We found this trial at
6
sites
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
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Tyler, Texas 75702
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