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

NCT01166490 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2013-08-27

No results posted yet for this study

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.

Conditions

  • Gastric Neoplasms
  • Pancreatic Neoplasms

Interventions

DRUG

ASG-5ME

0.3-3.0 mg/kg IV on Days 1, 8, and 15 of 28-day cycles

Sponsors & Collaborators

  • Agensys, Inc.

    collaborator INDUSTRY

  • Seagen Inc.

    lead INDUSTRY

Principal Investigators

  • Nancy Whiting, PharmD, BCOP · Seagen Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01166490 on ClinicalTrials.gov