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Gastrointestinal Stromal Tumor (GIST)Phase 3ENESTg1NCT00785785

A Study of Nilotinib Versus Imatinib in GIST Patients

A Phase 3 study testing Nilotinib (AMN107) and imatinib (STI571) in people with Gastrointestinal Stromal Tumor (GIST), run by Novartis Pharmaceuticals at 165 sites in 35 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 evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastrointestinal Stromal Tumor (GIST)
What is being tested?
Nilotinib (AMN107) and imatinib (STI571)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
644 participants
Where
165 sitesin 35 countries
Study dates
Mar 2009to Oct 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histologically confirmed diagnosis of GIST which is unresectable and/or metastatic and either:
  • have not received any prior anti-neoplastic therapy other than adjuvant imatinib. Note: newly diagnosed patients may have received up to 14 days of treatment with imatinib for disease management while awaiting entry to the study or
  • recurrent GIST after stopping adjuvant treatment with imatinib and no subsequent treatment with any other therapies.
  • At least one measurable site of disease on CT/MRI scan
  • Performance status ≤ 2 (capable of self-care but unable to carry out any work)
  • Normal organ, electrolyte and marrow function

Who cannot join

  • Any prior anti-neoplastic therapy with the exception of patients who have received adjuvant imatinib or patients with newly diagnosed metastatic/ unresectable GIST whose disease requires therapy while awaiting entry to the study.
  • Disease progression during adjuvant therapy with imatinib
  • History of active malignancy (other than GIST) within 10 years prior to study entry with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ.
  • Impaired cardiac function
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

165 sites in 35 countries.

165 sites in 35 countries

United States28 sites

  • University of Michigan Comprehensive Cancer Center DeptofMichiganCancerCenter(6)

    Ann Arbor, Michigan, 48109-0944

  • University of Colorado Dept. of Univ. of Colorado

    Aurora, Colorado, 80045

  • Texas Oncology, P.A. Tex Onc (2)

    Bedford, Texas, 76022

  • Birmingham Hematology and Oncology Associates

    Birmingham, Alabama, 35205

  • Dana Farber Cancer Institute Centerfor Sarcoma&BoneOncology

    Boston, Massachusetts, 02215

  • Northwestern University Clinical Research Office (2)

    Chicago, Illinois, 60611

  • Kootenai Medical Center Dept.ofKootenai Med.Ctr.

    Coeur d'Alene, Idaho, 83814

  • Texas Oncology Wichita Falls

    Dallas, Texas, 75246

  • University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(3)

    Dallas, Texas, 75390-8527

  • City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(4)

    Duarte, California, 91010-3000

  • City of Hope National Medical Center Regulatory Document

    Duarte, California, 91010-3000

  • Northern Arizona Hematology/Oncology Associates, P.C. Dept. of No. AZ Hem-Onc

    Flagstaff, Arizona, 86001

  • Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer

    Greenwood Village, Colorado

  • University of Texas/MD Anderson Cancer Center Dept. of MD Anderson (13)

    Houston, Texas, 77030-4009

  • University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (2)

    La Jolla, California, 92093-0658

  • University of California at Los Angeles GI Oncology Program

    Los Angeles, California, 90095

  • Minnesota Oncology Hematology, P.A. SC

    Minneapolis, Minnesota, 55404

  • Vanderbilt Univeristy Ingram Cancer Ctr.

    Nashville, Tennessee, 37232

  • Ocala Oncology Center Dept. of Ocala Oncology Center

    Ocala, Florida, 34474

  • University of Pennsylvania Medical Center CAMN107G2301

    Philadelphia, Pennsylvania, 19104-4283

  • Mayo Clinic - Rochester Division of Hematology

    Rochester, Minnesota, 55905

  • University of Utah / Huntsman Cancer Institute Dept.ofHuntsmanCancerInst.(3)

    Salt Lake City, Utah, 84112

  • Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)

    San Antonio, Texas, 78229

  • Stanford University Medical Center Stanford Cancer Center

    Stanford, California, 94304

  • New York Oncology Hematology, P.C. NYOH Amsterdam

    Troy, New York, 12180

  • New York Oncology Hematology, P.C. NYOH@AlbanyMedicalCenter(2)

    Troy, New York, 12180

  • Tyler Cancer Center Dept.ofTylerCancerCtr. (2)

    Tyler, Texas, 75702

  • Washington Hospital Center Wash Hospital

    Washington D.C., District of Columbia, 20010

Other trials in United States

Japan15 sites

  • Novartis Investigative Site

    Chuo-ku, Tokyo, 104-0045

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 812-8582

  • Novartis Investigative Site

    Gifu, Gifu, 501-1194

  • Novartis Investigative Site

    Kashiwa, Chiba, 277-8577

  • Novartis Investigative Site

    Kumamoto, Kumamoto, 860-8556

  • Novartis Investigative Site

    Kurashiki, Okayama-ken, 701-0192

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 464-8681

  • Novartis Investigative Site

    Niigata, Niigata, 951-8520

  • Novartis Investigative Site

    Osaka, Osaka, 540-0006

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-8648

  • Novartis Investigative Site

    Sendai, Miyagi, 980-8574

  • Novartis Investigative Site

    Suita, Osaka, 565-0871

  • Novartis Investigative Site

    Sunto-gun, Shizuoka, 411-8777

  • Novartis Investigative Site

    Toyama, Toyama, 930-0194

  • Novartis Investigative Site

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

Italy10 sites

  • Novartis Investigative Site

    Aviano, PN, 33081

  • Novartis Investigative Site

    Bologna, BO, 40138

  • Novartis Investigative Site

    Candiolo, TO, 10060

  • Novartis Investigative Site

    Florence, FI, 50134

  • Novartis Investigative Site

    Genova, GE, 16132

  • Novartis Investigative Site

    Milan, MI, 20133

  • Novartis Investigative Site

    Modena, MO, 41100

  • Novartis Investigative Site

    Palermo, PA, 90127

  • Novartis Investigative Site

    San Giovanni Rotondo, FG, 71013

  • Novartis Investigative Site

    Torino, TO, 10153

Other trials in Italy

France9 sites

  • Novartis Investigative Site

    Bordeaux, 33076

  • Novartis Investigative Site

    Chambray-lès-Tours, 37170

  • Novartis Investigative Site

    Lyon, 69373

  • Novartis Investigative Site

    Marseille, 13385

  • Novartis Investigative Site

    Paris, 75651

  • Novartis Investigative Site

    Saint-Herblain Cédex, 44805

  • Novartis Investigative Site

    Toulouse, 31054

  • Novartis Investigative Site

    Vandœuvre-lès-Nancy, 54511

  • Novartis Investigative Site

    Villejuif, 94805

Other trials in France

Canada8 sites

  • Novartis Investigative Site

    Halifax, Nova Scotia, B3H 1V7

  • Novartis Investigative Site

    Hamilton, Ontario, L8V 5C2

  • Novartis Investigative Site

    Montreal, Quebec, H1T 2M4

  • Novartis Investigative Site

    Montreal, Quebec, H3A 1A1

  • Novartis Investigative Site

    Ottawa, Ontario, K1H 8L6

  • Novartis Investigative Site

    Québec, Quebec, G1R 2J6

  • Novartis Investigative Site

    Toronto, Ontario, M5G1X5

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Germany7 sites

  • Novartis Investigative Site

    Bad Saarow, 15526

  • Novartis Investigative Site

    Düsseldorf, 40479

  • Novartis Investigative Site

    Essen, 45122

  • Novartis Investigative Site

    Hanover, 30625

  • Novartis Investigative Site

    Mannheim, 68167

  • Novartis Investigative Site

    München, 81377

  • Novartis Investigative Site

    Weiden, 92637

Other trials in Germany

China6 sites

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 100730

  • Novartis Investigative Site

    Beijing, 100036

  • Novartis Investigative Site

    Guangzhou, 510060

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210002

  • Novartis Investigative Site

    Shanghai, 200032

  • Novartis Investigative Site

    Shanghai, 200433

Other trials in China

Sweden6 sites

  • Novartis Investigative Site

    Gothenburg, SE-413 45

  • Novartis Investigative Site

    Linköping, SE-581 85

  • Novartis Investigative Site

    Lund, SE-221 85

  • Novartis Investigative Site

    Stockholm, SE-171 76

  • Novartis Investigative Site

    Umeå, SE-901 85

  • Novartis Investigative Site

    Uppsala, SE-751 85

Other trials in Sweden

Turkey (Türkiye)6 sites

  • Novartis Investigative Site

    Adana, Turkey, 01330

  • Novartis Investigative Site

    Ankara, Turkey, 06100

  • Novartis Investigative Site

    Ankara, Turkey, 06500

  • Novartis Investigative Site

    Balcova / Izmir, 35340

  • Novartis Investigative Site

    Izmir, Turkey, 35040

  • Novartis Investigative Site

    Kartal, 34890

Other trials in Turkey (Türkiye)

United Kingdom6 sites

  • Novartis Investigative Site

    Cambridge, CB2 2QQ

  • Novartis Investigative Site

    Glasgow, G12 0YN

  • Novartis Investigative Site

    London, NW1 2BU

  • Novartis Investigative Site

    London, SW3 6JJ

  • Novartis Investigative Site

    Manchester, M20 4BX

  • Novartis Investigative Site

    Newcastle upon Tyne, Newcastle-upon-Tyne, NE7 7DN

Other trials in United Kingdom

Austria5 sites

  • Novartis Investigative Site

    Graz, 8036

  • Novartis Investigative Site

    Innsbruck, Tyrol, 6020

  • Novartis Investigative Site

    Leoben, A-8700

  • Novartis Investigative Site

    Vienna, A-1090

  • Novartis Investigative Site

    Wels, 4600

Other trials in Austria

South Africa5 sites

  • Novartis Investigative Site

    Cape Town, 7500

  • Novartis Investigative Site

    Johannesburg, 2199

  • Novartis Investigative Site

    Pretoria, 0001

  • Novartis Investigative Site

    Pretoria, 0002

  • Novartis Investigative Site

    Pretoria, 0027

Other trials in South Africa

Brazil4 sites

  • Novartis Investigative Site

    Campinas, São Paulo, 13083-970

  • Novartis Investigative Site

    Florianópolis, Santa Catarina, 88034-000

  • Novartis Investigative Site

    São Paulo, São Paulo, 04023-900

  • Novartis Investigative Site

    Uberlândia, Minas Gerais, 38408-150

Other trials in Brazil

Romania4 sites

  • Novartis Investigative Site

    Bucharest, 022328

  • Novartis Investigative Site

    Cluj-Napoca, 3400

  • Novartis Investigative Site

    Craiova, Dolj, 200535

  • Novartis Investigative Site

    Iași, 700106

Other trials in Romania

Russia4 sites

  • Novartis Investigative Site

    Kazan', Tatarstan Republic, 420029

  • Novartis Investigative Site

    Moscow, 115478

  • Novartis Investigative Site

    Saint Petersburg, 198255

  • Novartis Investigative Site

    Yekaterinburg, 620036

Other trials in Russia

Spain4 sites

  • Novartis Investigative Site

    Barcelona, Barcelona, 08041

  • Novartis Investigative Site

    Madrid, Madrid, 28046

  • Novartis Investigative Site

    Oviedo, Principality of Asturias, 33006

  • Novartis Investigative Site

    Sabadell, Barcelona, 08208

Other trials in Spain

Taiwan4 sites

  • Novartis Investigative Site

    Linkou District, 33305

  • Novartis Investigative Site

    Niaosong Township, Taiwan, 83301

  • Novartis Investigative Site

    Taipei, Taiwan, 10002

  • Novartis Investigative Site

    Taipei, Taiwan, ROC, 112

Other trials in Taiwan

Thailand4 sites

  • Novartis Investigative Site

    Bangkok, 10330

  • Novartis Investigative Site

    Bangkok, 10700

  • Novartis Investigative Site

    Khon Kaen, 40002

  • Novartis Investigative Site

    Songkhla, 90110

Other trials in Thailand

Argentina3 sites

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1264AAA

  • Novartis Investigative Site

    Caba, Buenos Aires, C1426ANZ

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000PBH

Other trials in Argentina

Mexico3 sites

  • Novartis Investigative Site

    Chihuahua City, Chihuahua, 31000

  • Novartis Investigative Site

    León, Guanajuato, 37000

  • Novartis Investigative Site

    Mexico City, Mexico City, 14080

Other trials in Mexico

South Korea3 sites

  • Novartis Investigative Site

    Seoul, Korea, 05505

  • Novartis Investigative Site

    Seoul, Korea, 06351

  • Novartis Investigative Site

    Suwon, Gyeonggi-do, 443-380

Other trials in South Korea

Bulgaria2 sites

  • Novartis Investigative Site

    Sofia, 1784

  • Novartis Investigative Site

    Varna, 9010

Other trials in Bulgaria

Denmark2 sites

  • Novartis Investigative Site

    Århus C, DK-8000

  • Novartis Investigative Site

    Herlev, DK-2730

Other trials in Denmark

Egypt2 sites

  • Novartis Investigative Site

    Alexandria

  • Novartis Investigative Site

    Cairo

Other trials in Egypt

Hungary2 sites

  • Novartis Investigative Site

    Budapest, 1062

  • Novartis Investigative Site

    Budapest, 1097

Other trials in Hungary

Israel2 sites

  • Novartis Investigative Site

    Haifa, 3525408

  • Novartis Investigative Site

    Ramat Gan, 5266202

Other trials in Israel

Poland2 sites

  • Novartis Investigative Site

    Krakow, 31-501

  • Novartis Investigative Site

    Warsaw, 02-781

Other trials in Poland

Singapore2 sites

  • Novartis Investigative Site

    Singapore, Singapore, 119228

  • Novartis Investigative Site

    Singapore, Singapore, 169610

Other trials in Singapore

Colombia1 site

  • Novartis Investigative Site

    Pereira

Other trials in Colombia

Czechia1 site

  • Novartis Investigative Site

    Olomouc, 775 20

Other trials in Czechia

Hong Kong1 site

  • Novartis Investigative Site

    Hong Kong SAR

Other trials in Hong Kong

Netherlands1 site

  • Novartis Investigative Site

    Leiden, 2300 RC

Other trials in Netherlands

Norway1 site

  • Novartis Investigative Site

    Oslo, NO-0310

Other trials in Norway

Slovakia1 site

  • Novartis Investigative Site

    Bratislava, Slovak Republic, 83310

Other trials in Slovakia

Venezuela1 site

  • Novartis Investigative Site

    Caracas, Distrito Federal, 1010

Other trials in Venezuela

About this study

Official title: A Randomized, Open Label, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Nilotinib Versus Imatinib in Adult Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST)

This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).

Being tested
Nilotinib (AMN107), imatinib (STI571)
Keywords
Unresectable GIST, metastatic GIST, nilotinib, AMN107, imatinib, STI571
Medical subject headings
Gastrointestinal Stromal Tumors

What participants receive

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

  • Nilotinib (AMN107)Drug

  • imatinib (STI571)Drug

    Also called Glivec/Gleevec

Study groups in NCT00785785
Study groupRoleWhat they receive
NilotinibExperimentalnilotinib 400 mg twice a day
Receives: Drug: Nilotinib (AMN107)
ImatinibActive comparatorimatinib 400 mg once daily
Receives: Drug: imatinib (STI571)

What is being measured

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

  1. Time to Progression Free Survival (PFS)

    PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

    Measured: up to month 37

Timeline

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

  1. First posted5 Nov 2008 (estimated)
  2. Study startMar 2009
  3. Primary completionOct 2014
  4. Study completionOct 2014

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
644 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00785785
Sponsor's protocol ID
CAMN107G2301
Other IDs
2008-004758-34, 2008
Acronym
ENESTg1
Status last verified
May 2016
First submitted
4 Nov 2008
Last updated
16 Jun 2016

Publications

  • Blay JY, Shen L, Kang YK, Rutkowski P, Qin S, Nosov D, Wan D, Trent J, Srimuninnimit V, Papai Z, Le Cesne A, Novick S, Taningco L, Mo S, Green S, Reichardt P, Demetri GD. Nilotinib versus imatinib as first-line therapy for patients with unresectable or metastatic gastrointestinal stromal tumours (ENESTg1): a randomised phase 3 trial. Lancet Oncol. 2015 May;16(5):550-60. doi: 10.1016/S1470-2045(15)70105-1. Epub 2015 Apr 14.

    PubMed 25882987

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nilotinib (AMN107) and imatinib (STI571) in people with Gastrointestinal Stromal Tumor (GIST), run by Novartis Pharmaceuticals at 165 sites in 35 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 6 inclusion and 5 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 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 165 sites in United States, Japan, Italy, France, Canada and 30 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time to Progression Free Survival (PFS) (time frame: up to month 37). 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 NCT00785785, 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 16 Jun 2016.

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