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Carcinoma, Pancreatic DuctalPhase 2NCT00902291

A Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer

A Phase 2 study testing AGS-1C4D4 and Gemcitabine in people with Carcinoma, Pancreatic Ductal and Pancreatic Cancer, run by Astellas Pharma Inc at 36 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A study to evaluate AGS-1C4D4 administered in combination with Gemcitabine chemotherapy in subjects with Metastatic Pancreatic Cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AGS-1C4D4 and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
205 participants
Where
36 sitesin 5 countries
Study dates
Apr 2009to Apr 2012
Phase
Phase 2
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 adenocarcinoma of the pancreas (AJCC Stage IV). Subjects with islet cell neoplasms are excluded
  • Non-measurable or measurable disease based on the RECIST criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Life expectancy of > 3 months
  • Hematologic function, as follows:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
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  • Platelet count ≥ 100 x 109/L
  • Hemoglobin ≥ 9 g/dL (transfusion independent)
  • Renal function, as follows:
  • Creatinine ≤ 2.0 mg/dL
  • Hepatic function, as follows:
  • Aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤ 5 x ULN if known liver metastases.
  • Alanine aminotransferase (ALT) ≤ 2.5 x ULN or ≤ 5 x ULN if known liver metastases
  • Bilirubin ≤ 2 x ULN
  • INR < 1.3 (or ≤ 3 if on warfarin for therapeutic anti-coagulation)

Who cannot join

  • Prior systemic therapy for metastatic pancreatic cancer
  • Subjects who have received adjuvant treatment with gemcitabine and who had relapse metastatically are allowed
  • Subjects with advanced local disease who have received treatment with gemcitabine and in whom progression has been observed with the onset of metastases less than 6 months are excluded
  • Chemotherapy and/or radiation within 4 weeks of study enrollment
  • Prior monoclonal antibody therapy within 60 days of study enrollment
  • Known brain or leptomeningeal disease
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  • History of other primary malignancy, unless:
  • Curatively resected non-melanomatous skin cancer
  • Other malignancy curatively treated with no known active disease present and no treatment administered for the last 3 years
  • Active angina or Class III or IV Congestive Heart Failure (New York Heart Association CHF Functional Classification System)
  • Use of any investigational product within 4 weeks of study enrollment
  • Major surgery (that requires general anesthesia) within 4 weeks before study enrollment
  • Women who are pregnant (confirmed by positive pregnancy test) or lactating
  • Man or woman of childbearing potential not consenting to use adequate contraceptive precautions during the course of the study and for 4 weeks after the last AGS-1C4D4 and/or gemcitabine infusion administration
  • Subject known to be human immunodeficiency, hepatitis B or hepatitis C virus positive
  • Active serious infection not controlled with antibiotics

Trial locations and contacts

36 sites in 5 countries.

36 sites in 5 countries

United States15 sites

  • Annapolis Oncology Center

    Annapolis, Maryland, 21401

  • Medical Oncology LLC

    Baton Rouge, Louisiana, 70809

  • Dana Farber Cancer Center

    Boston, Massachusetts, 02115

  • Palm Beach Institute of Hematology and Oncology

    Boynton Beach, Florida, 33435

  • Cancer Centers of the Carolinas

    Greenville, South Carolina, 29605

  • Baptist Regional Cancer Center

    Knoxville, Tennessee, 37920

  • University of California San Diego Medical Center

    La Jolla, California, 92093

  • Alan B. Pearson Regional Cancer Center Lynchburg Hematology Oncology Clinic

    Lynchburg, Virginia, 24501

  • University of Miami

    Miami, Florida, 33136

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Virginia G. Piper Cancer Center

    Minneapolis, Minnesota, 55407

  • Vanderbilt University Medical Center, Div. of Medical Oncology

    Nashville, Tennessee, 37232

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

  • Kaiser Permanente Northwest Region Oncology Hematology

    Portland, Oregon, 97227

  • Regional Oncology Center

    Syracuse, New York, 13210

Other trials in United States

Russia9 sites

  • State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"

    Arkhangelsk

  • Regional Oncology Dispensary

    Ivanovo

  • Clinical Oncology Dispensary of Republic of Tatarstan

    Kazan'

  • State Healthcare Institution "Leningrad Regional Oncologic Dispensary"

    Kuzmolovo

  • Non-state Healthcare Institution N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway"

    Moscow

  • Medical Radiology Research Center of Russian Medical Academy

    Obninsk

  • State Healthcare Institution of Omsk Region "Clinical Oncologic Dispensary"

    Omsk

  • Saint Petersburg State Healthcare Institution "Municipal Clinical Oncology Dispensary"

    Saint Petersburg

  • State Educational Institution "S.M. Kirov Military Medical Academy of Ministry of Defense of Russia"

    Saint Petersburg

Other trials in Russia

France6 sites

  • Chu Estaing

    Clermont-Ferrand

  • Centre Jean Bernard, Oncologie médicale

    Le Mans

  • Centre Régional de Lutte Contre le Cancer-Centre Oscar Lambret

    Lille

  • Hôpital du Haut Lèvêque, Service d'Hepato Gastroentérologie

    Pessac

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers

  • Hôpital Charles Nicolle

    Rouen

Other trials in France

Canada3 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Spain3 sites

  • Hospital Clinic i Provincial de Barcelona, Servicio de Oncologia

    Barcelona

  • Study site

    Madrid

  • Hospital Virgen de la Salud, Servicio Oncologia

    Toledo

Other trials in Spain

About this study

Official title: A Global, Multi-center, Open-label, Phase 2 Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer

A study to evaluate AGS-1C4D4 administered in combination with Gemcitabine chemotherapy in subjects with Metastatic Pancreatic Cancer.

Read the detailed description

A disease assessment will be performed at study week 8 (± 3 days) by the investigator. The assessment will be based both on changes in clinical symptoms, and radiographic images. Subjects without evidence of disease progression may continue to receive treatment based on their original treatment assignment until disease progression or intolerability. Disease assessments will be performed every 8 weeks during the extended period. A safety follow-up visit will occur 4 weeks after the last dose infusion of AGS-1C4D4 and/or gemcitabine.

Post-Treatment: Subjects terminating from protocol therapy for reasons unrelated to documented disease progression will be followed by telephone contact every 2 months until they begin a new anticancer therapy, their disease progresses, they die, become lost to follow-up or withdrawal consent for further follow-up, whichever of these events occurs first.

Overall survival: All subjects will be followed by telephone contact every 2 months until death, loss to follow-up, or withdrawal of consent, whichever of these events occurs first.

Being tested
AGS-1C4D4, Gemcitabine
Keywords
Clinical Trial, Phase II, Combination Drug Therapy, Gemcitabine, AGS-1C4D4, Pancreatic Cancer
Medical subject headings
Carcinoma, Pancreatic Ductal, Pancreatic Neoplasms, Pancreatic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AGS-1C4D4Biological

    IV infusion

  • GemcitabineBiological

    IV infusion

Study groups in NCT00902291
Study groupRoleWhat they receive
1. Gemcitabine monotherapyActive comparatorNot described
Receives: Biological: Gemcitabine
2. Gemcitabine plus AGS-1C4D4ExperimentalNot described
Receives: Biological: AGS-1C4D4; Biological: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival rate at 6 months

    Measured: 6 months

Secondary outcomes (6)

  1. Overall Survival (OS)

    Measured: Throughout treatment period and post-treatment every 2 months until death, or subject discontinues the study

  2. Progression free survival (PFS)

    Measured: Throughout treatment period or post-treatment every 2 months until disease progression or death, respectively, or subject discontinues the study

  3. Change in level of serum tumor marker CA 19-9

    Measured: Week 1, Week 4, Week 7 and every 3 weeks during the extended treatment period

  4. Incidence of anti-AGS-1C4D4 antibody formation

    Measured: Week 1, Week 7 and every 8 weeks during the extended treatment period

  5. Objective Response Rate (Partial Response or better per RECIST criteria version 1.1

    Measured: Week 8, and every 8 weeks during the extended treatment period

  6. Disease Control (Stable Disease or better per RECIST criteria)

    Measured: Week 8, and every 8 weeks during the extended treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionApr 2012
  4. Study completionApr 2012

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
205 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00902291
Sponsor's protocol ID
2008002
Other IDs
2009-009194-99, 2009
Status last verified
Aug 2015
First submitted
13 May 2009
Last updated
14 Sep 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Wolpin BM, O'Reilly EM, Ko YJ, Blaszkowsky LS, Rarick M, Rocha-Lima CM, Ritch P, Chan E, Spratlin J, Macarulla T, McWhirter E, Pezet D, Lichinitser M, Roman L, Hartford A, Morrison K, Jackson L, Vincent M, Reyno L, Hidalgo M. Global, multicenter, randomized, phase II trial of gemcitabine and gemcitabine plus AGS-1C4D4 in patients with previously untreated, metastatic pancreatic cancer. Ann Oncol. 2013 Jul;24(7):1792-1801. doi: 10.1093/annonc/mdt066. Epub 2013 Feb 28.

    PubMed 23448807

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AGS-1C4D4 and Gemcitabine in people with Carcinoma, Pancreatic Ductal and Pancreatic Cancer, run by Astellas Pharma Inc at 36 sites in 5 countries.

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 15 inclusion and 16 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 14 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States, Russia, France, Canada, Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Survival rate at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00902291, which also lists 1 linked publication.

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 14 Sep 2015.

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