Trial record 2 of 2 for:    asg-5me

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

This study has been completed.
Sponsor:
Collaborator:
Agensys, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01166490
First received: July 19, 2010
Last updated: August 23, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Gastric Neoplasms
Pancreatic Neoplasms
Drug: ASG-5ME
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:
  • Incidence of adverse events and laboratory abnormalities [ Time Frame: Through 1 month after last dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Best clinical response [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]
  • Overall and progression-free survival [ Time Frame: Every month until death or study closure ] [ Designated as safety issue: No ]
  • Concentrations of ASG-5ME and metabolites in blood [ Time Frame: Through 1 month after last dose ] [ Designated as safety issue: No ]
  • Incidence of antitherapeutic antibodies in blood [ Time Frame: Through 1 month after last dose ] [ Designated as safety issue: Yes ]

Enrollment: 51
Study Start Date: July 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ASG-5ME
Drug: ASG-5ME
0.3-3.0 mg/kg IV on Days 1, 8, and 15 of 28-day cycles

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166490

Locations
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.
Investigators
Study Director: Nancy Whiting, PharmD, BCOP Seattle Genetics, Inc.
  More Information

No publications provided

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01166490     History of Changes
Other Study ID Numbers: ASG5ME-002
Study First Received: July 19, 2010
Last Updated: August 23, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Adenocarcinoma
Neoplasms
Stomach Neoplasms
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 21, 2014