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

Sponsor

Seagen Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01166490

Collaborator

Agensys, Inc. (Industry)

Enrollment

Locations

Arm

Duration (Months)

7.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Neoplasms Pancreatic Neoplasms	Drug: ASG-5ME	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

51 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence of adverse events and laboratory abnormalities [Through 1 month after last dose]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TGen Clinical Research Service at Scottsdale Healthcare	Scottsdale	Arizona	United States	85259
2	University of California at San Francisco	San Francisco	California	United States	94115
3	University of Chicago	Chicago	Illinois	United States	60637-1470
4	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
5	Texas Oncology - Baylor Sammons Cancer Center	Dallas	Texas	United States	75246
6	Texas Oncology - Tyler	Tyler	Texas	United States	75702
7	Seattle Cancer Care Alliance / University of Washington	Seattle	Washington	United States	98109-1023