NCT01166490

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2010

Typical duration for phase_1

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

August 27, 2013

Status Verified

August 1, 2013

Enrollment Period

3 years

First QC Date

July 19, 2010

Last Update Submit

August 23, 2013

Conditions

Gastric NeoplasmsPancreatic Neoplasms

Keywords

Monomethyl auristatin E (MMAE)ImmunotherapyAGS-5 AntigenSLC44A4 AntigenGastric NeoplasmsPancreatic NeoplasmsAntibody-Drug ConjugateAntibodies, MonoclonalDrug Therapy

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events and laboratory abnormalities

    Through 1 month after last dose

Secondary Outcomes (4)

  • 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

Study Arms (1)

1

EXPERIMENTAL

ASG-5ME

Drug: ASG-5ME

Interventions

ASG-5MEDRUG

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

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

TGen Clinical Research Service at Scottsdale Healthcare

Scottsdale, Arizona, 85259, United States

Location

University of California at San Francisco

San Francisco, California, 94115, United States

Location

University of Chicago

Chicago, Illinois, 60637-1470, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Texas Oncology - Baylor Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Texas Oncology - Tyler

Tyler, Texas, 75702, United States

Location

Seattle Cancer Care Alliance / University of Washington

Seattle, Washington, 98109-1023, United States

Location

MeSH Terms

Conditions

Stomach NeoplasmsPancreatic Neoplasms

Interventions

ASG-5ME

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Nancy Whiting, PharmD, BCOP

    Seagen Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2010

First Posted

July 21, 2010

Study Start

July 1, 2010

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

August 27, 2013

Record last verified: 2013-08

Locations

US(7)