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

July 19, 2010
August 23, 2013
July 2010
July 2013   (final data collection date for primary outcome measure)
Incidence of adverse events and laboratory abnormalities [ Time Frame: Through 1 month after last dose ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01166490 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Phase 1 Dose Escalation Trial of ASG-5ME in Pancreatic or Gastric Adenocarcinoma
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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Gastric Neoplasms
  • Pancreatic Neoplasms
Drug: ASG-5ME
0.3-3.0 mg/kg IV on Days 1, 8, and 15 of 28-day cycles
Experimental: 1
ASG-5ME
Intervention: Drug: ASG-5ME
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01166490
ASG5ME-002
No
Seattle Genetics, Inc.
Seattle Genetics, Inc.
Agensys, Inc.
Study Director: Nancy Whiting, PharmD, BCOP Seattle Genetics, Inc.
Seattle Genetics, Inc.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP