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

Phase 1

Completed

• Conditions: Pancreatic Neoplasms; Gastric Neoplasms
• Interventions: Drug: ASG-5ME

• Registration Number: NCT01166490
• Lead Sponsor: Seagen 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-19
• Study First Submitted QC: 2010-07-19
• Study First Posted: 2010-07-21
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-23
• Last Update Posted: 2013-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	ASG-5ME	ASG-5ME

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events and laboratory abnormalities	Through 1 month after last dose

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Texas Oncology - Tyler; 🇺🇸 Tyler, Texas, United States

Texas Oncology - Baylor Sammons Cancer Center; 🇺🇸 Dallas, Texas, United States

Seattle Cancer Care Alliance / University of Washington; 🇺🇸 Seattle, Washington, United States

TGen Clinical Research Service at Scottsdale Healthcare; 🇺🇸 Scottsdale, Arizona, United States

University of California at San Francisco; 🇺🇸 San Francisco, California, United States