A Phase 1 Dose Escalation Trial Of ASG-5ME In Pancreatic Or Gastric Adenocarcinoma

Study Overview

A Phase 1 Dose Escalation Trial of ASG-5ME in 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.

N/A

Gastric Neoplasms
Pancreatic Neoplasms

DRUG: ASG-5ME

ASG5ME-002

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-07-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-08-23
First Submitted that Met QC Criteria 2010-07-19	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-08-27
First Posted (ESTIMATED) 2010-07-21	Results First Posted N/A	Last Verified 2013-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 1 ASG-5ME	DRUG: ASG-5ME 0.3-3.0 mg/kg IV on Days 1, 8, and 15 of 28-day cycles

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 1

ASG-5ME

DRUG: ASG-5ME

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

Primary Outcome Measures	Measure Description	Time Frame
Incidence of adverse events and laboratory abnormalities		Through 1 month after last dose

Secondary Outcome Measures	Measure Description	Time Frame
Best clinical response		Every 2 months
Overall and progression-free survival		Every month until death or study closure
Concentrations of ASG-5ME and metabolites in blood		Through 1 month after last dose
Incidence of antitherapeutic antibodies in blood		Through 1 month after last dose

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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).

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Agensys, Inc.

Investigators

STUDY_DIRECTOR: Nancy Whiting, PharmD, BCOP, Seagen Inc.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record