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

Seagen Inc.7 sites in 1 country51 target enrollmentJuly 2010

ConditionsGastric Neoplasms Pancreatic Neoplasms

InterventionsASG-5ME

DrugsASG-5ME

Overview

Phase: Phase 1
Intervention: ASG-5ME
Conditions: Gastric Neoplasms
Sponsor: Seagen Inc.
Enrollment: 51
Locations: 7
Primary Endpoint: Incidence of adverse events and laboratory abnormalities
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2010

End Date

July 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Seagen Inc.

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

1

ASG-5ME

Intervention: ASG-5ME

Outcomes

Primary Outcomes

Incidence of adverse events and laboratory abnormalities

Time Frame: Through 1 month after last dose

Secondary Outcomes

Best clinical response(Every 2 months)
Incidence of antitherapeutic antibodies in blood(Through 1 month after last dose)
Concentrations of ASG-5ME and metabolites in blood(Through 1 month after last dose)
Overall and progression-free survival(Every month until death or study closure)