Trial record 1 of 4 for:
DCC | GIST
A Study of DCC-2618 vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib (intrigue)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03673501 |
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Recruitment Status :
Recruiting
First Posted : September 17, 2018
Last Update Posted : February 20, 2020
|
Sponsor:
Deciphera Pharmaceuticals LLC
Information provided by (Responsible Party):
Deciphera Pharmaceuticals LLC
- Study Details
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Brief Summary:
This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of DCC-2618 to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 358 patients will be randomized in a 1:1 ratio to DCC-2618 150 mg once daily (QD) (continuous dosing for 6 week cycles) or sunitinib 50 mg QD (6 week cycles, 4 weeks on, 2 weeks off).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastrointestinal Stromal Tumors | Drug: DCC-2618 Drug: Sunitinib | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 358 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of DCC-2618 vs Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumors After Treatment With Imatinib |
| Actual Study Start Date : | February 11, 2019 |
| Estimated Primary Completion Date : | June 2021 |
| Estimated Study Completion Date : | March 2022 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Gastrointestinal stromal tumor
| Arm | Intervention/treatment |
|---|---|
|
Experimental: DCC-2618
150 mg QD DCC-2618
|
Drug: DCC-2618
Oral KIT/PDGFRA kinase inhibitor
Other Name: ripretinib |
|
Active Comparator: sunitinib
50 mg QD sunitinib
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Drug: Sunitinib
Oral receptor tyrosine kinase (RTK) inhibitor
Other Name: Sutent |
Primary Outcome Measures :
- Progression free survival (PFS) [ Time Frame: 30 months ]PFS Based on independent radiologic review using modified RECIST
Secondary Outcome Measures :
- Objective response rate (ORR) [ Time Frame: 30 months ]Objective response rate as determined by confirmed CR + confirmed PR by independent radiologic review
- Overall Survival (OS) [ Time Frame: 30 months ]Measure of overall survival
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients ≥ 18 years of age at the time of informed consent.
- Histologic diagnosis of GIST and must be able to provide an archival tumor tissue sample, otherwise, a fresh biopsy is required.
- Molecular pathology report must be available. If molecular pathology report is not available or insufficient, an archival tumor tissue sample or fresh biopsy is required for mutation status confirmation by the central laboratory prior to randomization.
- Patients must have progressed on imatinib or have documented intolerance to imatinib.
- Eastern Cooperative Oncology Group (ECOG) PS of ≤ 2 at screening.
- Female patients of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test at screening and negative pregnancy test at Cycle 1 Day 1 prior to the first dose of study drug.
- Patients of reproductive potential must agree to follow the contraception requirements outlined in the study protocol.
- Patients must have at least 1 measurable lesion according to mRECIST Version 1.1 (non nodal lesions must be ≥ 1.0 cm in the long axis or ≥ double the slice thickness in the long axis) within 21 days prior to the first dose of study drug.
- Adequate organ function and bone marrow reserve as indicated by the central laboratory assessments performed at screening.
- Resolution of all toxicities from prior therapy to ≤ Grade 1 (or patient baseline) within 1 week prior to the first dose of study drug (excluding alopecia and ≤ Grade 3 clinically asymptomatic lipase, amylase, and creatine phosphokinase [CPK] laboratory abnormalities).
- The patient is capable of understanding and complying with the protocol and the patient has signed the informed consent document. Signed informed consent form (ICF) must be obtained before any study-specific procedures are performed.
Exclusion Criteria:
- Treatment with any other line of therapy in addition to imatinib for advanced GIST. Imatinib-containing combination therapy in the first-line setting is not allowed.
- Patients with a prior or concurrent malignancy whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of this clinical trial are not eligible.
- Patient has known active central nervous system metastases.
- New York Heart Association class II-IV heart disease, myocardial infarction within 6 months of cycle 1 day 1, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure.
- Left ventricular ejection fraction (LVEF) < 50% at screening.
- Arterial thrombotic or embolic events such as cerebrovascular accident (including ischemic attacks) or hemoptysis within 6 months before the first dose of study drug.
- Venous thrombotic events (e.g. deep vein thrombosis) or pulmonary arterial events (e.g. pulmonary embolism) within 1 month before the first dose of study drug. Patients on stable anticoagulation therapy for at least one month are eligible.
- 12-lead ECG demonstrating QT interval corrected (QTc) by Fridericia's formula > 450 ms in males or > 470 ms in females at screening or history of long QTc syndrome
- Use of known substrates or inhibitors of BCRP transporters within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of study drug.
- Major surgeries (e.g. abdominal laparotomy) within 4 weeks of the first dose of study drug. All major surgical wounds must be healed and free of infection or dehiscence before the first dose of study drug.
- Any other clinically significant comorbidities.
- Known human immunodeficiency virus or hepatitis C infection only if the patient is taking medications that are excluded per protocol, active hepatitis B, or active hepatitis C infection.
- If female, the patient is pregnant or lactating.
- Known allergy or hypersensitivity to any component of the study drug.
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Gastrointestinal abnormalities including but not limited to:
- inability to take oral medication
- malabsorption syndromes
- requirement for intravenous (IV) alimentation
- Any active bleeding excluding hemorrhoidal or gum bleeding.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03673501
Contacts
| Contact: Clinical Team | 785-830-2100 | clinicaltrials@deciphera.com |
Locations
Hide 106 study locations
| United States, Arizona | |
| Mayo Clinic Scottsdale | Recruiting |
| Scottsdale, Arizona, United States, 85259 | |
| Contact: Mahesh Seetharam | |
| United States, California | |
| University of California San Diego Medical Center | Recruiting |
| La Jolla, California, United States, 92103 | |
| Contact: Adam Burgoyne | |
| UCLA Hematology Oncology Center - Main Site | Recruiting |
| Los Angeles, California, United States, 90024 | |
| Contact: Arun Singh | |
| Stanford Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Kristen Ganjoo | |
| United States, Colorado | |
| University of Colorado Hospital - Anschutz Cancer Pavillion | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Anthony Elias | |
| Rocky Mountain Cancer Centers | Recruiting |
| Denver, Colorado, United States, 80220 | |
| Contact: Allen Cohn | |
| United States, Connecticut | |
| Smilow Cancer Hospital at Yale | Recruiting |
| New Haven, Connecticut, United States, 06511 | |
| Contact: Hari Deshpande | |
| United States, Florida | |
| Mayo Clinic Florida | Recruiting |
| Jacksonville, Florida, United States, 32224 | |
| Contact: Steven Attia 904-953-7292 | |
| Sylvester Comprehensive Cancer Center | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Jonathan Trent | |
| Miami Cancer Institute at Baptist Health, Inc. | Recruiting |
| Miami, Florida, United States, 33176 | |
| Contact: Santiago Aparo | |
| Principal Investigator: Santiago Aparo | |
| Orlando Health UF Health Cancer Center | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Thomas Sajeve | |
| Moffitt Cancer Center | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Mihaela Druta | |
| United States, Georgia | |
| Winship Cancer Institute | Recruiting |
| Atlanta, Georgia, United States, 30332 | |
| Contact: William Read | |
| Georgia Cancer Specialists | Recruiting |
| Sandy Springs, Georgia, United States, 30342 | |
| Contact: Bordoni | |
| United States, Illinois | |
| Northwestern Memorial Hospital | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Mark Agulnik | |
| University of Chicago Medical Center | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Hedy Kindler | |
| United States, Indiana | |
| IU Simon Cancer Center | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Daniel Rushing | |
| United States, Iowa | |
| University of Iowa Hospital and Clinics | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Varun Monga | |
| United States, Kentucky | |
| Norton Cancer Institute, Audubon Hospital Campus | Recruiting |
| Louisville, Kentucky, United States, 40241 | |
| Contact: John Hamm | |
| United States, Maryland | |
| Johns Hopkins Hospital | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Christian Meyer | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Suzanne George | |
| United States, Michigan | |
| Henry Ford Health System | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Ira Wollner | |
| United States, Minnesota | |
| University of Minnesota Medical Center-Fairview | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Keith Skubitz | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Siontis | |
| United States, Missouri | |
| Washington University School of Medicine - Siteman Cancer Center | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Brian Van Tine | |
| United States, New York | |
| Montefiore Medical Center-Montefiore Medical Park | Recruiting |
| Bronx, New York, United States, 10467 | |
| Contact: Jennifer Chuy | |
| The Monter Cancer Center | Recruiting |
| Lake Success, New York, United States, 11042 | |
| Contact: Tony Philip | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Ping Chi | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Richard Riedel | |
| United States, Ohio | |
| The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Solove Research Institute | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Gabriel Tinoco | |
| University of Toledo | Completed |
| Toledo, Ohio, United States, 43606 | |
| United States, Oklahoma | |
| Stephenson Cancer Center | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Sagila George | |
| United States, Oregon | |
| Oregon Health & Science University Center for Health and Healing | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Michael Heinrich | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | Recruiting |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Contact: vonMehren | |
| United States, Tennessee | |
| Henry-Joyce Cancer Clinic | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Vicki Keedy | |
| United States, Texas | |
| Texas Oncology-Baylor Charles A. Sammons Cancer Center | Recruiting |
| Dallas, Texas, United States, 75246 | |
| Contact: Paulson | |
| University of Texas MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Neeta Somaiah | |
| United States, Virginia | |
| Emily Couric Clinical Cancer Center | Recruiting |
| Charlottesville, Virginia, United States, 22903 | |
| Contact: Reilley | |
| Virginia Commonwealth University Massey Cancer Center | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: Sosipatros Boikos | |
| United States, Washington | |
| University of Washington Medical Center | Recruiting |
| Seattle, Washington, United States, 98195 | |
| Contact: Michael Wagner | |
| United States, Wisconsin | |
| Froedtert Hospital-Medical College of Wisconsin | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: John Charlson | |
| Argentina | |
| Sanatorio Allende | Recruiting |
| Córdoba, Cordoba, Argentina, X5000JHQ | |
| Contact: Gustavo Jarchum | |
| Instituto Medicao Especializado Alexander Fleming | Recruiting |
| Buenos Aires, Argentina | |
| Contact: Matias Chacon | |
| Australia, New South Wales | |
| Border Medical Oncology Research Unit | Recruiting |
| Albury, New South Wales, Australia | |
| Contact: Craig Underhill | |
| Prince of Wales Hospital | Recruiting |
| Randwick, New South Wales, Australia, 2031 | |
| Contact: David Goldstein | |
| Australia, Queensland | |
| Princess Alexandra Hospital | Recruiting |
| Woolloongabba, Queensland, Australia | |
| Contact: Warren Joubert | |
| Australia, South Australia | |
| Ashford Cancer Centre Research | Recruiting |
| Kurralta Park, South Australia, Australia, 5037 | |
| Contact: Dusan Kotasek | |
| Ashford Cancer Centre Research | Recruiting |
| Kurralta Park, South Australia, Australia | |
| Contact: Sarwan Bishnoi | |
| Australia, Victoria | |
| The Alfred Hospital | Recruiting |
| Melbourne, Victoria, Australia, 3004 | |
| Contact: John Zalcberg | |
| Belgium | |
| Institut Jules Bordet | Recruiting |
| Bruxelles, Belgium | |
| Contact: Thierry Gil | |
| UZ Leuven | Recruiting |
| Leuven, Belgium | |
| Contact: Patrick Schoffski | |
| Canada, Alberta | |
| Cross Cancer Institute | Recruiting |
| Edmonton, Alberta, Canada | |
| Contact: Karen Mulder | |
| Canada, Manitoba | |
| CancerCare Manitoba | Recruiting |
| Winnipeg, Manitoba, Canada | |
| Contact: Shantanu Banerji | |
| Canada, Ontario | |
| Juravinski Cancer Centre | Recruiting |
| Hamilton, Ontario, Canada | |
| Contact: Kevin Zbuk | |
| The Ottawa Hospital Cancer Centre | Recruiting |
| Ottawa, Ontario, Canada | |
| Contact: Timothy Asmis | |
| Princess Margaret Cancer Centre | Recruiting |
| Toronto, Ontario, Canada, M5G 2C1 | |
| Contact: Albiruni Razak | |
| Chile | |
| Clinica San Carlos de Apoquindo Red Salud UC Christs | Recruiting |
| Santiago, Chile | |
| Contact: Marcelo Adan Garrido Salvo | |
| Czechia | |
| Fakultni nemocnice v Motole | Recruiting |
| Prague, Czechia | |
| Contact: Jana Prausova | |
| France | |
| Institut Bergonnié | Recruiting |
| Bordeaux, France | |
| Contact: Antoine Italiano | |
| Centre Georges François Leclerc | Recruiting |
| Dijon, France | |
| Contact: Alice Hervieu | |
| Centre Oscar Lambret | Recruiting |
| Lille Cedex, France | |
| Contact: Nicolas Penel | |
| Centre Léon Bérard | Recruiting |
| Lyon, France | |
| Contact: Jean-Yves Blay | |
| Hopital La Timone | Recruiting |
| Marseille, France | |
| Contact: Florence Duffaud | |
| IPC | Recruiting |
| Marseille, France | |
| Contact: Francois Bertucci | |
| IGR | Recruiting |
| Paris, France | |
| Contact: Axel Le Cesne | |
| ICO - Site René Gauducheau | Recruiting |
| Saint Herblain, France | |
| Contact: Emmanuelle Bompas | |
| Germany | |
| HELIOS Klinikum Berlin-Buch | Recruiting |
| Berlin, Germany | |
| Contact: Peter Reichardt | |
| West German Cancer Center | Recruiting |
| Essen, Germany | |
| Contact: Sebastian Bauer | |
| Hungary | |
| Magyar Honvedseg Egeszsegugyi Kozpont | Recruiting |
| Budapest, Hungary | |
| Contact: Zsuzsanna Papai | |
| Debreceni Egyetem | Recruiting |
| Debrecen, Hungary | |
| Contact: Peter Arkosy | |
| Italy | |
| Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi | Recruiting |
| Bologna, Italy | |
| Contact: Maria Pantaleo | |
| stituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori | Recruiting |
| Meldola, Italy | |
| Contact: Toni Ibrahim | |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Recruiting |
| Milan, Italy | |
| Contact: Elena Fumagalli | |
| IOV - Istituto Oncologico Veneto IRCCS | Recruiting |
| Padova, Italy | |
| Contact: Antonella Brunello | |
| Università Campus Bio-Medico di Roma | Recruiting |
| Rome, Italy | |
| Contact: Bruno Vincenzi | |
| Korea, Republic of | |
| Asan Medical Center | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Yoon-Koo Kang | |
| Samsung Medical Center | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Joon Oh Park | |
| Seoul National University Hospital | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Kyung-Hun Lee | |
| Principal Investigator: Tae-Young Kim | |
| Ajou University Hospital | Recruiting |
| Suwon, Korea, Republic of | |
| Contact: Seok Yun Kang | |
| Netherlands | |
| Antoni van Leeuwenhoek | Recruiting |
| Amsterdam, Netherlands | |
| Contact: Ingrid Desar | |
| The Netherlands Cancer Institute | Recruiting |
| Amsterdam, Netherlands | |
| Contact: Neeltje Steeghs | |
| Leiden University Medical Centre | Recruiting |
| Leiden, Netherlands | |
| Contact: Hans Gelderblom | |
| Norway | |
| Oslo University Hospital | Recruiting |
| Oslo, Norway | |
| Contact: Kjetil Boye | |
| Poland | |
| Centrum Onkologii-Instytut im. M. Sklodowskiej Curie | Recruiting |
| Warsaw, Poland | |
| Contact: Piotr Rutowski | |
| Singapore | |
| National Cancer Centre | Recruiting |
| Singapore, Singapore, 169610 | |
| Contact: Nagavalli Somasundaram | |
| Principal Investigator: Eileen Poon Ying Ling | |
| Spain | |
| Hospital de la Santa Creu i Sant Pau | Recruiting |
| Barcelona, Spain | |
| Contact: Antonio Lopez Pousa | |
| Hospital Universitari Vall d'Hebron | Recruiting |
| Barcelona, Spain | |
| Contact: Cesar Garcia Serrano | |
| Hospital de Basurto | Recruiting |
| Bilbao, Spain | |
| Contact: Maria Angelas Sala Gonzalez | |
| Hospital Universitario Clinico San Carlos | Recruiting |
| Madrid, Spain | |
| Contact: Antonio Casado Herraez | |
| Hospital Universitario HM Madrid Sanchinarro | Recruiting |
| Madrid, Spain | |
| Contact: Antonio Cubillo Gracian | |
| Hospital Universitario La Paz | Recruiting |
| Madrid, Spain | |
| Contact: Virginia Martinez Marin | |
| Hospital Universitario Ramon y Cajal | Recruiting |
| Madrid, Spain | |
| Contact: Maria Angeles Vaz Salgado | |
| Hospital Clinico Universitario Virgen de la Victoria | Recruiting |
| Malaga, Spain | |
| Contact: Isabel Garcia Sevilla | |
| Hospital Universitario Virgen del Rocio | Recruiting |
| Sevilla, Spain | |
| Contact: Nadia Hindi | |
| Instituto Valenciano de Oncología, | Recruiting |
| Valencia, Spain | |
| Contact: Javier Lavernia Giner | |
| Complejo Hospitalario Universitario de Vigo | Recruiting |
| Vigo, Spain | |
| Contact: Juan Antonio Carrasco Alvarez | |
| Sweden | |
| Karolinska universitetssjukhuset | Recruiting |
| Solna, Sweden | |
| Contact: Antroula Papakonstantinou | |
| Taiwan | |
| Chang Gung Memorial Hospital | Recruiting |
| Linkou, Taoyuan County, Taiwan | |
| Contact: Chun-Nan Yeh | |
| China Medical University Hospital | Recruiting |
| Taichung, Taiwan | |
| Contact: Li-Yuan Bai | |
| National Chen Kung University Hospital | Recruiting |
| Tainan, Taiwan | |
| Contact: Chia-Jui Yen | |
| Taipei Veterans General Hospital | Recruiting |
| Taipei, Taiwan | |
| Contact: Yen Chueh-Chuan | |
| United Kingdom | |
| Beatson West of Scotland Cancer Centre | Recruiting |
| Glasgow, United Kingdom | |
| Contact: Jeffrey White | |
| St James's University Hospital | Recruiting |
| Leeds, United Kingdom | |
| Contact: Daniel Stark | |
| Royal Marsden Hospital - Fulham | Recruiting |
| London, United Kingdom | |
| Contact: Robin Jones | |
| University College London Hospitals | Recruiting |
| London, United Kingdom | |
| Contact: Palma Dileo | |
| Weston Park Hospital | Recruiting |
| Sheffield, United Kingdom | |
| Contact: Robin Young | |
Sponsors and Collaborators
Deciphera Pharmaceuticals LLC
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Deciphera Pharmaceuticals LLC |
| ClinicalTrials.gov Identifier: | NCT03673501 |
| Other Study ID Numbers: |
DCC-2618-03-002 |
| First Posted: | September 17, 2018 Key Record Dates |
| Last Update Posted: | February 20, 2020 |
| Last Verified: | February 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
|
Gastrointestinal Stromal Tumors Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Imatinib Mesylate |
Sunitinib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |