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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Gastric Neoplasms, Pancreatic Neoplasms

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of adverse events and laboratory abnormalities

Outcome Time Frame:

Through 1 month after last dose

Safety Issue:

Yes

Principal Investigator

Nancy Whiting, PharmD, BCOP

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

ASG5ME-002

NCT ID:

NCT01166490

Start Date:

July 2010

Completion Date:

October 2013

Related Keywords:

  • Gastric Neoplasms
  • Pancreatic Neoplasms
  • Monomethyl auristatin E (MMAE)
  • Immunotherapy
  • AGS-5 Antigen
  • SLC44A4 Antigen
  • Gastric Neoplasms
  • Pancreatic Neoplasms
  • Antibody-Drug Conjugate
  • Antibodies, Monoclonal
  • Drug Therapy
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Stomach Neoplasms
  • Pancreatic Neoplasms

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
University of ChicagoChicago, Illinois  60637
University of California at San FranciscoSan Francisco, California  94115
Texas Oncology - TylerTyler, Texas  75702
Texas Oncology - Baylor Sammons Cancer CenterDallas, Texas  75426
TGEN Clinical Research Service at Scottsdale HealthcareScottsdale, Arizona  85258
Seattle Cancer Care Alliance / University of WashingtonSeattle, Washington  98109-1023