A Phase 1 Dose Escalation Trial of ASG-5ME in Pancreatic or Gastric Adenocarcinoma
This study is currently recruiting participants.
Verified March 2013 by Seattle Genetics, Inc.
Sponsor:
Seattle Genetics, Inc.
Collaborator:
Agensys, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01166490
First received: July 19, 2010
Last updated: March 28, 2013
Last verified: March 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Gastric Neoplasms Pancreatic Neoplasms |
Drug: ASG-5ME |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Seattle Genetics, Inc.:
Primary Outcome Measures:
- Incidence of adverse events and laboratory abnormalities [ Time Frame: Through 1 month after last dose ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Best clinical response [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]
- Overall and progression-free survival [ Time Frame: Every month until death or study closure ] [ Designated as safety issue: No ]
- Concentrations of ASG-5ME and metabolites in blood [ Time Frame: Through 1 month after last dose ] [ Designated as safety issue: No ]
- Incidence of antitherapeutic antibodies in blood [ Time Frame: Through 1 month after last dose ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 52 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
ASG-5ME
|
Drug: ASG-5ME
0.3-3.0 mg/kg IV on Days 1, 8, and 15 of 28-day cycles
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166490
Contacts
| Contact: Terri Lowe | 866-333-7436 | clinicaltrials@seagen.com |
Locations
| United States, Arizona | |
| TGen Clinical Research Service at Scottsdale Healthcare | Recruiting |
| Scottsdale, Arizona, United States, 85259 | |
| Contact: Lynne Hull 480-323-1071 lhull@shc.org | |
| Principal Investigator: Daniel Von Hoff, M.D. | |
| United States, Illinois | |
| University of Chicago Comprehensive Cancer Center | Recruiting |
| Chicago, Illinois, United States, 60637-1470 | |
| Contact: Odessa Jones ojones@bsd.uchicago.edu | |
| Principal Investigator: Daniel Catenacci, M.D. | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Kara Sullivan 617-632-6313 KaraA_Sullivan@dfci.harvard.edu | |
| Principal Investigator: Brian Wolpin, M.D. | |
| United States, Texas | |
| Texas Oncology - Baylor Sammons Cancer Center | Recruiting |
| Dallas, Texas, United States, 75246 | |
| Contact: Claire Peterson 214-370-1949 claire.peterson@usoncology.com | |
| Principal Investigator: Carlos Becerra, M.D. | |
| Texas Oncology - Tyler | Recruiting |
| Tyler, Texas, United States, 75702 | |
| Contact: Karen Poe 903-579-9869 Karen.Poe@USOncology.com | |
| Principal Investigator: Donald Richards, M.D. | |
| United States, Washington | |
| Seattle Cancer Care Alliance / University of Washington | Recruiting |
| Seattle, Washington, United States, 98109-1023 | |
| Contact: Erica Peters 206-288-6538 etucker@seattlecca.org | |
| Principal Investigator: Andrew Coveler, MD | |
Sponsors and Collaborators
Seattle Genetics, Inc.
Agensys, Inc.
Investigators
| Study Director: | Nancy Whiting, PharmD, BCOP | Seattle Genetics, Inc. |
More Information
No publications provided
| Responsible Party: | Seattle Genetics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01166490 History of Changes |
| Other Study ID Numbers: | ASG5ME-002 |
| Study First Received: | July 19, 2010 |
| Last Updated: | March 28, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Seattle Genetics, Inc.:
|
Monomethyl auristatin E (MMAE) Immunotherapy AGS-5 Antigen SLC44A4 Antigen Gastric Neoplasms |
Pancreatic Neoplasms Antibody-Drug Conjugate Antibodies, Monoclonal Drug Therapy |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Neoplasms Stomach Neoplasms Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Cystic, Mucinous, and Serous |
Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013