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

Pancreatic Neoplasms Clinical Trial

Official title:

A Phase 1, Open-Label, Dose Escalation Study of ASG-5ME in Patients With Pancreatic or Gastric Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01166490
• Other study ID #: ASG5ME-002
• Status: Completed
• Phase: Phase 1
• First received: July 19, 2010
• Last updated: August 23, 2013
• Start date: July 2010
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Neoplasms
• Neoplasms
• Pancreatic Neoplasms
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	University of Chicago	Chicago	Illinois
United States	Texas Oncology - Baylor Sammons Cancer Center	Dallas	Texas
United States	University of California at San Francisco	San Francisco	California
United States	TGen Clinical Research Service at Scottsdale Healthcare	Scottsdale	Arizona
United States	Seattle Cancer Care Alliance / University of Washington	Seattle	Washington
United States	Texas Oncology - Tyler	Tyler	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.	Agensys, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events and laboratory abnormalities		Through 1 month after last dose	Yes
Secondary	Best clinical response		Every 2 months	No
Secondary	Overall and progression-free survival		Every month until death or study closure	No
Secondary	Concentrations of ASG-5ME and metabolites in blood		Through 1 month after last dose	No
Secondary	Incidence of antitherapeutic antibodies in blood		Through 1 month after last dose	Yes