SCCA Clinical Studies: Phase 1 Program
Dose Escalation Study of ASG-5ME for Gastric Adenocarcinoma (UW10011)
A Phase 1, Open-Label, Dose Escalation Study of ASG-5ME in Patients With Pancreatic or Gastric Adenocarcinoma
| Status | Conditions | Phase | Study ID |
| Closed | Pancreatic Neoplasms | Phase I |
UW10011 NCT01166490 |
Summary
This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety and tolerability of ASG-5ME and to identify the maximum tolerated dose in patients with pathologically confirmed metastatic pancreatic adenocarcinoma.
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Eligibility Criteria (must meet the following to participate in this study)
| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Pathologically confirmed metastatic pancreatic 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. 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
Last Updated
March 26, 2013See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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Please remember:
- Talk to your health care providers first before making decisions about your health care.
- Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.