Gastric NeoplasmsPhase 1NCT01166490
A Phase 1 Dose Escalation Trial of ASG-5ME in Pancreatic or Gastric Adenocarcinoma
A Phase 1 study testing ASG-5ME in people with Gastric Neoplasms and Pancreatic Neoplasms, run by Seagen Inc. at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Neoplasms, Pancreatic Neoplasms
- What is being tested?
- ASG-5ME
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 7 sitesUnited States
- Study dates
- Jul 2010to Jul 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University of Chicago
Chicago, Illinois, 60637-1470
Texas Oncology - Baylor Sammons Cancer Center
Dallas, Texas, 75246
University of California at San Francisco
San Francisco, California, 94115
TGen Clinical Research Service at Scottsdale Healthcare
Scottsdale, Arizona, 85259
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, 98109-1023
Texas Oncology - Tyler
Tyler, Texas, 75702
About this study
Official title: A Phase 1, Open-Label, Dose Escalation Study of ASG-5ME in Patients With 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.
- Conditions
- Gastric Neoplasms, Pancreatic Neoplasms
- Being tested
- ASG-5ME
- Keywords
- Monomethyl auristatin E (MMAE), Immunotherapy, AGS-5 Antigen, SLC44A4 Antigen, Gastric Neoplasms, Pancreatic Neoplasms, Antibody-Drug Conjugate, Antibodies, Monoclonal, Drug Therapy
- Medical subject headings
- Stomach Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASG-5MEDrug
0.3-3.0 mg/kg IV on Days 1, 8, and 15 of 28-day cycles
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ASG-5ME Receives: Drug: ASG-5ME |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events and laboratory abnormalities
Measured: Through 1 month after last dose
Secondary outcomes (4)
Best clinical response
Measured: Every 2 months
Overall and progression-free survival
Measured: Every month until death or study closure
Concentrations of ASG-5ME and metabolites in blood
Measured: Through 1 month after last dose
Incidence of antitherapeutic antibodies in blood
Measured: Through 1 month after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Agensys, Inc.
- Responsible party
- Sponsor
- Investigators
- Nancy Whiting, PharmD, BCOP, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166490
- Sponsor's protocol ID
- ASG5ME-002
- Status last verified
- Aug 2013
- First submitted
- 19 Jul 2010
- Last updated
- 27 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Dose Escalation Study of ASG-5ME in Patients With Pancreatic or Gastric Adenocarcinoma
- ClinicalTrials.gov ID
- NCT01166490
- Acronym / sponsor ID
- ASG5ME-002
- Conditions
- Gastric Neoplasms, Pancreatic Neoplasms
- Keywords
- Monomethyl auristatin E (MMAE), Immunotherapy, AGS-5 Antigen, SLC44A4 Antigen, Gastric Neoplasms, Pancreatic Neoplasms, Antibody-Drug Conjugate, Antibodies, Monoclonal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Collaborators
- Agensys, Inc.
- Study start
- Jul 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 21 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ASG-5MEASG-5ME |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASG-5ME0.3-3.0 mg/kg IV on Days 1, 8, and 15 of 28-day cycles | Drug | 1 |
Primary outcome
Incidence of adverse events and laboratory abnormalities
Time frame: Through 1 month after last dose
4 secondary outcomes
Best clinical response
Time frame: Every 2 months
Overall and progression-free survival
Time frame: Every month until death or study closure
Concentrations of ASG-5ME and metabolites in blood
Time frame: Through 1 month after last dose
Incidence of antitherapeutic antibodies in blood
Time frame: Through 1 month after last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Whiting, PharmD, BCOP study director
Seagen Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASG-5ME in people with Gastric Neoplasms and Pancreatic Neoplasms, run by Seagen Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events and laboratory abnormalities (time frame: Through 1 month after last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2013.