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Pancreatic CancerPhase 2NCT01472198

A Study to Evaluate the Efficacy and Safety of Simtuzumab Combined With Gemcitabine for Metastatic Pancreatic Adenocarcinoma

A Phase 2 study testing Simtuzumab and Gemcitabine in people with Pancreatic Cancer, run by Gilead Sciences at 57 sites in 2 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

This study will compare the efficacy of simtuzumab (GS-6624) versus placebo in combination with gemcitabine in adults with pancreatic cancer. The treatment phase of this study will be comprised of 2 sequential parts: an open label treatment phase and a double-blinded treatment phase. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Simtuzumab and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
250 participants
Where
57 sitesin 2 countries
Study dates
Nov 2011to Feb 2015
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

  • Initial diagnosis of metastatic pancreatic cancer must have occurred ≤6 weeks prior to the completion of screening.
  • The presence of measurable metastatic pancreatic cancer documented by contrast enhanced CT (or MRI) scan in addition to 1 of the following:
  • Histological diagnosis of pancreatic adenocarcinoma confirmed by pathologist OR
  • Pathologist confirmed histological/cytological diagnosis of adenocarcinoma consistent with pancreatic origin in conjunction with either:
  • The presence of a mass in the pancreas OR
  • A history of resected pancreatic carcinoma
Show all 9Show fewer
  • Measurable disease per RECIST (ver. 1.1)
  • ECOG Performance Status of 0 or 1.
  • Adequate hepatic, hematologic and renal functions.

Who cannot join

  • A history or evidence of clinically significant disorder other than metastatic cancer of the pancreas.
  • A diagnosis of pancreatic islet neoplasms.
  • Subject has undergone major surgery other than diagnosis surgery within 4 weeks of randomization
  • Presence of biliary obstruction requiring external drainage
  • Brain metastases.
  • Unstable cardiovascular function within the last 6 months of screening
Show all 13Show fewer
  • Clinically active liver disease, including active viral hepatitis (HBV or HCV) or cirrhosis
  • Known HIV infection.
  • Uncontrolled hypertension at Screening
  • History or presence of any form of cancer, other than pancreatic cancer, within the 3 years prior to enrollment
  • Prior or concurrent anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) for the treatment of inoperable locally advanced or metastatic pancreatic cancer; prior radiotherapy and chemotherapy given as pre-operative neoadjuvant therapy or radio sensitizers for locally advanced pancreatic cancer are allowed.
  • Uncontrolled systemic fungal, bacterial or viral infection
  • Participation in an investigational drug or device trial with therapeutic intent within 30 days prior to study

Trial locations and contacts

57 sites in 2 countries.

57 sites in 2 countries

United States44 sites

  • Central Hematology Oncology Medical Group, Inc.

    Alhambra, California

  • Anne Arundel Medical Center, Annapolis Oncology Center

    Annapolis, Maryland

  • Georgia Cancer Specialists, P.C.

    Atlanta, Georgia, 30341

  • Comprehensive Blood and Cancer Center

    Bakersfield, California

  • Birmingham Hematology and Oncology Associates, LLC

    Birmingham, Alabama

  • Oncology Hematology Care, Inc.

    Blue Ash, Ohio, 45242

  • Charleston Hematology Oncology Associates, PA

    Charleston, South Carolina

  • Northwestern University

    Chicago, Illinois

  • South Carolina Oncology Associates

    Columbia, South Carolina

  • Coastal Bend Cancer Center

    Corpus Christi, Texas

  • Oncology Hematology Care, Inc.

    Crestview Hills, Kentucky, 41017

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas

  • Duke University Medical Center, Comprehensive Cancer Center

    Durham, North Carolina

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia

  • San Antonio Military Medical Center

    Fort Sam Houston, Texas, 78234

  • Center for Cancer and Blood Disorders, PC

    Fort Worth, Texas

  • California Cancer Associates for Research and Excellence (CCARE)

    Fresno, California, 93720

  • Saint Mary's Regional Cancer Center

    Grand Junction, Colorado

  • PinnacleHealth

    Harrisburg, Pennsylvania, 17109

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada

  • Emerywood Hematology and Oncology

    High Point, North Carolina

  • West Michigan Cancer Center

    Kalamazoo, Michigan

  • Tennessee Cancer Specialists

    Knoxville, Tennessee

  • Pacific Shores Medical Group

    Long Beach, California

  • UCLA Community Oncology Practice

    Los Angeles, California

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas

  • Montana Cancer Institute Foundation c/o Montana Cancer Specialists

    Missoula, Montana

  • University of South Alabama Mitchell Cancer Institute

    Mobile, Alabama, 36604

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37206

  • Saint Luke's-Roosevelt Hospital Center

    New York, New York, 10003

  • Beth Israel Comprehensive Cancer Center

    New York, New York

  • Stanford University Medical Center

    Palo Alto, California

  • Wilshire Oncology Medical Group, Inc.

    Rancho Cucamonga, California, 91730

  • Virginia Cancer Institute

    Richmond, Virginia

  • Saint Joseph Oncology, Inc.

    Saint Joseph, Missouri

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • Sharp Health Care

    San Diego, California, 92123

  • San Jose Medical Group

    San Jose, California, 95116

  • Providence Cancer Center Oncology and Hematology Care Clinic-Eastside Portland

    Southfield, Michigan, 48075

  • Washington University School of Medicine

    St Louis, Missouri, 63108

  • Hematology Oncology Associates, PC

    Stamford, Connecticut

  • Florida Cancer Specialists

    Tampa, Florida, 33607

  • Hematology and Oncology Associates at BridgePoint

    Tupelo, Mississippi

  • Abington Hematology Oncology Associates, Inc.

    Willow Grove, Pennsylvania, 19090

Other trials in United States

Russia13 sites

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

    Arkhangelsk, Primorskiy (Maritime) Kray, 163045

  • Regional Oncology Dispensary

    Ivanovo, Ivanovo Oblast, 153040

  • Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan

    Kazan', Tatarstan Republic, 420029

  • Kursk Regional Oncologic Dispensary

    Kursk, Kursk Oblast, 305035

  • Blokhin Cancer Research Center of Russia, Dept. of clinical pharmacology

    Moscow, Moscow, 115478

  • State Institution "Blokhin Cancer Research Centre RAMS"

    Moscow, Moscow, 115478

  • Non-State Institution of healthcare "Central Clinical Hospital #1 OAO RZD

    Moscow, Moscow, 125367

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

    Moscow, Moscow, 129128

  • State Budgetary Healthcare Institution "Nizhny Novgorod Regional Oncological Dispensary"

    Nizhny Novgorod, 603081

  • Medical Radiological Research Center of Russian Academy of Medical Sciences, Obninsk

    Obninsk, Kaluga Oblast, 249036

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

    Omsk, 644013

  • Petrov Research Oncology Institute

    Saint Petersburg, 197758

  • Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan

    Ufa, Bashkortostan Republic, 450054

Other trials in Russia

About this study

Official title: A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined With Gemcitabine as First Line Treatment for Metastatic Pancreatic Adenocarcinoma

This study will compare the efficacy of simtuzumab (GS-6624) versus placebo in combination with gemcitabine in adults with pancreatic cancer. The treatment phase of this study will be comprised of 2 sequential parts: an open label treatment phase and a double-blinded treatment phase.

Being tested
Simtuzumab, Gemcitabine, Placebo to match simtuzumab
Keywords
GSI, Gilead, Gilead Sciences, Pancreatic Cancer, PC, Gemcitabine, Phase 2, Phase II, GS-6624, Oncology, Monoclonal Antibody
Medical subject headings
Pancreatic Neoplasms, Neoplasms

What participants receive

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

  • SimtuzumabDrug

    Also called GS-6624

    Simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)

  • GemcitabineDrug

    Also called Gemzar®

    Gemcitabine 1000 mg/m^2 administered intravenously on Days 1, 8, and 15 of each 28-day cycle

  • Placebo to match simtuzumabDrug

    Placebo to match simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)

Study groups in NCT01472198
Study groupRoleWhat they receive
Simtuzumab (open-label)ExperimentalParticipants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years.
Receives: Drug: Simtuzumab; Drug: Gemcitabine
Simtuzumab 200 mg (randomized)ExperimentalParticipants will receive simtuzumab 200 mg plus gemcitabine in cycles of 28 days for up to 3 years.
Receives: Drug: Simtuzumab; Drug: Gemcitabine
Simtuzumab 700 mg (randomized)ExperimentalParticipants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years.
Receives: Drug: Simtuzumab; Drug: Gemcitabine
Placebo (randomized)Placebo comparatorParticipants will receive placebo to match simtuzumab plus gemcitabine in cycles of 28 days for up to 3 years.
Receives: Drug: Gemcitabine; Drug: Placebo to match simtuzumab

What is being measured

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

  1. Progression free survival

    Progression free survival is measured as time from date of randomization to the earliest event time of death regardless of cause or first indication of disease progression.

    Measured: Up to 3 years

Secondary outcomes (2)

  1. Overall survival

    Overall survival is measured as time from date of randomization to death regardless of cause.

    Measured: Up to 3 years

  2. Objective response

    Objective response is assessed by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 as complete response, partial response, stable disease, or progressive disease.

    Measured: Up to 3 years

Timeline

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

  1. First posted16 Nov 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionOct 2013
  4. Study completionFeb 2015

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01472198
Sponsor's protocol ID
GS-US-324-0101
Status last verified
Feb 2015
First submitted
10 Nov 2011
Last updated
10 Mar 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Benson AB 3rd, Wainberg ZA, Hecht JR, Vyushkov D, Dong H, Bendell J, Kudrik F. A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Simtuzumab or Placebo in Combination with Gemcitabine for the First-Line Treatment of Pancreatic Adenocarcinoma. Oncologist. 2017 Mar;22(3):241-e15. doi: 10.1634/theoncologist.2017-0024. Epub 2017 Feb 28.

    PubMed 28246206

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Simtuzumab and Gemcitabine in people with Pancreatic Cancer, run by Gilead Sciences at 57 sites in 2 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 9 inclusion and 13 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 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Russia. 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. Some participants in this study may receive a placebo. 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?

Progression free survival (time frame: Up to 3 years). 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 NCT01472198, 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 10 Mar 2015.

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