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

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ClinicalTrials.gov Identifier: NCT01166490
Recruitment Status : Completed
First Posted : July 21, 2010
Last Update Posted : August 27, 2013
Agensys, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.

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 metastatic pancreatic adenocarcinoma, and to evaluate safety and tolerability in patients with relapsed or refractory gastric adenocarcinoma.

Condition or disease Intervention/treatment Phase
Gastric Neoplasms Pancreatic Neoplasms Drug: ASG-5ME Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Dose Escalation Study of ASG-5ME in Patients With Pancreatic or Gastric Adenocarcinoma
Study Start Date : July 2010
Primary Completion Date : July 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug: ASG-5ME
0.3-3.0 mg/kg IV on Days 1, 8, and 15 of 28-day cycles

Primary Outcome Measures :
  1. Incidence of adverse events and laboratory abnormalities [ Time Frame: Through 1 month after last dose ]

Secondary Outcome Measures :
  1. Best clinical response [ Time Frame: Every 2 months ]
  2. Overall and progression-free survival [ Time Frame: Every month until death or study closure ]
  3. Concentrations of ASG-5ME and metabolites in blood [ Time Frame: Through 1 month after last dose ]
  4. Incidence of antitherapeutic antibodies in blood [ Time Frame: Through 1 month after last dose ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166490

United States, Arizona
TGen Clinical Research Service at Scottsdale Healthcare
Scottsdale, Arizona, United States, 85259
United States, California
University of California at San Francisco
San Francisco, California, United States, 94115
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637-1470
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Texas
Texas Oncology - Baylor Sammons Cancer Center
Dallas, Texas, United States, 75246
Texas Oncology - Tyler
Tyler, Texas, United States, 75702
United States, Washington
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, United States, 98109-1023
Sponsors and Collaborators
Seattle Genetics, Inc.
Agensys, Inc.
Study Director: Nancy Whiting, PharmD, BCOP Seattle Genetics, Inc.

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01166490     History of Changes
Other Study ID Numbers: ASG5ME-002
First Posted: July 21, 2010    Key Record Dates
Last Update Posted: August 27, 2013
Last Verified: August 2013

Keywords provided by Seattle Genetics, Inc.:
Monomethyl auristatin E (MMAE)
AGS-5 Antigen
SLC44A4 Antigen
Gastric Neoplasms
Pancreatic Neoplasms
Antibody-Drug Conjugate
Antibodies, Monoclonal
Drug Therapy

Additional relevant MeSH terms:
Pancreatic Neoplasms
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Stomach Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs