Efficacy of Pazopanib in Gastrointestinal Stromal Tumors (GIST)
NCT ID: NCT01323400
Last Updated: 2016-02-25
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
81 participants
Study Classification
INTERVENTIONAL
Study Start Date
2011-03-31
Study Completion Date
2016-02-29
Brief Summary
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The purpose of this study is to evaluate the antitumor activity of pazopanib in patients with metastatic and/or locally advanced unresectable Gastrointestinal Stromal Tumors (GIST) resistant to imatinib and sunitinib. This is a phase II, randomized, multicentre study.
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Detailed Description
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Complete resection, with or without associated anticancer therapy, is the standard treatment of GIST. Even though the prognosis of advanced GIST has been tremendously improved by the introduction of tyrosine kinase inhibitors (TKI-imatinib, sunitinib...), the vast majority of patients will develop secondary resistance to these agents. The therapeutic options for patients with advanced GIST with resistance (or intolerance) to imatinib and sunitinib remain very limited. Some new molecules are currently being evaluated in patients with metastatic or locally advanced - imatinib-resistant disease. Nilotinib, for instance, has been evaluated in phase I/II trials and compassionate use programs with a median progression-free survival (PFS) close to 3 months and a median overall survival close to 8.5 months. A phase III trial comparing nilotinib vs. best supportive care (BSC) +/- imatinib or sunitinib (investigators choice) has just been completed and results are pending. Another molecule, Sorafenib, has been evaluated in 4th line treatment in compassionate use studies, with a median PFS close to 5 months and a median overall survival of 10-13 months. There are currently no recognized standard options after failure of 2nd line treatment, and the recently updated guidelines from the NCCN or ESMO (2009) suggest the possible reintroduction of TKI in an attempt to control the progression of sensitive cell clones.
Pazopanib is a broad spectrum TKI targeting KIT, PDGFR and VEGFR which has been tested in phase II trials in advanced sarcomas and has demonstrated promising antitumor activity. Whether pazopanib would be useful in patients with GIST is not known.
In the present study, we propose to analyze the antitumor activity of pazopanib in patients with GIST refractory to imatinib and sunitinib. The drug will be tested against BSC in a randomized setting, with possible crossing-over to the no-treatment arm.
Pazopanib is a broad spectrum TKI targeting KIT, PDGFR and VEGFR which has been tested in phase II trials in advanced sarcomas and has demonstrated promising antitumor activity. Whether pazopanib would be useful in patients with GIST is not known.
In the present study, we propose to analyze the antitumor activity of pazopanib in patients with GIST refractory to imatinib and sunitinib. The drug will be tested against BSC in a randomized setting, with possible crossing-over to the no-treatment arm.
Conditions
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GIST
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Pazopanib
Pazopanib (800 mg/day) + Best supportive care according to the investigator's judgement.
Pazopanib treatment is started on the day after randomization until radiological progression according to RECIST or until documented toxicity. In case of radiological progression, pazopanib may be continued (if the investigator wishes so) if a clinical benefit (pain reduction, 1 point increase in performance status) is observed.
Group Type
EXPERIMENTAL
Pazopanib
Intervention Type
DRUG
Pazopanib is administered orally at 800 mg/day (one dose every morning). A dose modification is possible in case of documented toxicity, according to specific algorithms.
Best supportive care
Intervention Type
OTHER
Best supportive care according to the investigator's judgment (chemotherapy, immunotherapy, hormone therapy are not allowed).
Non-targeted radiation therapy is tolerated, as antalgic strategy. Surgery is tolerated in case of emergency.
Best supportive care
Best supportive care according to the investigator's judgment. Upon progression, compassionate treatment by pazopanib is possible according to eligibility criteria.
Group Type
OTHER
Best supportive care
Intervention Type
OTHER
Best supportive care according to the investigator's judgment (chemotherapy, immunotherapy, hormone therapy are not allowed).
Non-targeted radiation therapy is tolerated, as antalgic strategy. Surgery is tolerated in case of emergency.
Interventions
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Pazopanib
Pazopanib is administered orally at 800 mg/day (one dose every morning). A dose modification is possible in case of documented toxicity, according to specific algorithms.
Intervention Type
DRUG
Best supportive care
Best supportive care according to the investigator's judgment (chemotherapy, immunotherapy, hormone therapy are not allowed).
Non-targeted radiation therapy is tolerated, as antalgic strategy. Surgery is tolerated in case of emergency.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
1. Age ≥ 18 years.
2. Histologically confirmed, unresectable, metastatic and/or locally advanced GIST.
3. Progression or intolerance after treatment with at least imatinib (400 mg and 600/800 mg/d) then sunitinib at either 50mg/d on a 4w/6w schedule or 37.5mg/d continuous dosing. Intolerance is defined as documented grade 3 or higher toxicity requiring treatment interruption as documented in patient record.
4. Measurable disease according to RECIST v1.1.
5. Performance status ≤ 2 (WHO).
6. Left Ventricular Ejection Fraction (LVEF) in accordance with local standards.
7. Adequate organ system functions as defined below:
* Haematologic parameters
* Absolute neutrophil count (ANC) ≥ 1.5 G/L
* Haemoglobin ≥ 9 g/dL
* Platelets ≥ 100 G/L
* Prothrombin time (PT) or international normalized ratio (INR) ≤ 1.2 X upper limit of normal (ULN) NB: Subjects receiving anticoagulation therapy are eligible if INR is stable and within the recommended range.
* Partial thromboplastin time (PTT) ≤ 1.2 X ULN
* Hepatic parameters
* Total bilirubin ≤ 1.5 X ULN
* AST and ALT ≤ 2.5 X ULN
* Renal parameters
* Serum creatinine ≤ 1.5 mg/dL (133 µmol/L) or, if greater than 1.5 mg/dL: calculated creatinine clearance ≥ 50 mL/min
* Urine Protein to Creatinine ratio (UPC) \< 1. If UPC ≥ 1, subjects must have a 24-hour urine protein value \<1g to be eligible.
* Biochemical parameters
* Kaliemia ≥ 1 X lower limit of normal (LLN)
8. a) Females of non-childbearing potential (i.e., physiologically incapable of becoming pregnant).
b) Females of childbearing potential provided that they are not pregnant or lactating, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and who agrees to use adequate contraception.
9. Affiliation with a health insurance company.
10. Subjects must provide written informed consent
2. Histologically confirmed, unresectable, metastatic and/or locally advanced GIST.
3. Progression or intolerance after treatment with at least imatinib (400 mg and 600/800 mg/d) then sunitinib at either 50mg/d on a 4w/6w schedule or 37.5mg/d continuous dosing. Intolerance is defined as documented grade 3 or higher toxicity requiring treatment interruption as documented in patient record.
4. Measurable disease according to RECIST v1.1.
5. Performance status ≤ 2 (WHO).
6. Left Ventricular Ejection Fraction (LVEF) in accordance with local standards.
7. Adequate organ system functions as defined below:
* Haematologic parameters
* Absolute neutrophil count (ANC) ≥ 1.5 G/L
* Haemoglobin ≥ 9 g/dL
* Platelets ≥ 100 G/L
* Prothrombin time (PT) or international normalized ratio (INR) ≤ 1.2 X upper limit of normal (ULN) NB: Subjects receiving anticoagulation therapy are eligible if INR is stable and within the recommended range.
* Partial thromboplastin time (PTT) ≤ 1.2 X ULN
* Hepatic parameters
* Total bilirubin ≤ 1.5 X ULN
* AST and ALT ≤ 2.5 X ULN
* Renal parameters
* Serum creatinine ≤ 1.5 mg/dL (133 µmol/L) or, if greater than 1.5 mg/dL: calculated creatinine clearance ≥ 50 mL/min
* Urine Protein to Creatinine ratio (UPC) \< 1. If UPC ≥ 1, subjects must have a 24-hour urine protein value \<1g to be eligible.
* Biochemical parameters
* Kaliemia ≥ 1 X lower limit of normal (LLN)
8. a) Females of non-childbearing potential (i.e., physiologically incapable of becoming pregnant).
b) Females of childbearing potential provided that they are not pregnant or lactating, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and who agrees to use adequate contraception.
9. Affiliation with a health insurance company.
10. Subjects must provide written informed consent
Exclusion Criteria
1. Prior malignant disease (other than GIST) within 3 years prior to entry, with the exception of in situ breast cell carcinoma or in situ carcinoma of the cervix or basocellular carcinoma or spinocellular carcinoma or bladder neoplasm, treated at least 6 months before and with no evidence of relapse.
2. History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for patients with previously-treated CNS metastases, who are asymptomatic and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug. CNS screening with computed tomography \[CT\] or magnetic resonance imaging \[MRI\] is required only if clinically indicated or if the subject has a history of CNS metastases.
3. Treatment with any of the following anti-cancer therapies:
* radiation therapy, surgery or tumour embolisation within 14 days prior to the first dose of pazopanib OR
* chemotherapy, biological therapy or investigational therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib.
The analgesic radiation therapy is allowed (the irradiated lesions won't be chosen as target lesions during the evaluation)
4. Any ongoing toxicity from prior anti-cancer therapy that is \> Grade 1 followed and/or progressing in severity, except alopecia.
5. Other uncontrolled severe medical conditions.
6. Presence of uncontrolled infection.
7. Clinically significant gastrointestinal abnormalities
* that may increase the risk for gastrointestinal bleeding.
* that may affect absorption of investigational product.
8. Poorly controlled hypertension \[defined as systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg\].
NB: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. BP must be re-assessed on two occasions at \> 1 hour interval; on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be \<140/90 mmHg for the subject to be eligible to the study.
9. History of any cardiovascular pathology within the past 6 months.
10. Corrected QT interval (QTcB) \> 480 msec using Bazett's formula.
11. History of cerebrovascular accident, including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT), within the past 6 months.
NB: Subjects with recent DVT treated with therapeutic anti-coagulating agents at least 6 weeks before inclusion are eligible.
12. Major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture or ulcer (procedures such as catheter placement are not considered to be major).
13. Evidence of active bleeding or bleeding diathesis.
14. Haemoptysis within 8 weeks before inclusion.
15. Platelet transfusion in the past 7 days.
16. Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels.
17. Concomitant bilirubin and AST/ALT elevations above ULN.
18. Treatment with anti-vitamin K (LMWH are allowed).
19. Inability or unwillingness to discontinue prohibited medications for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study.
20. Inability to swallow.
21. Pregnant or lactating woman
22. Impossibility to comply with protocol constraints
2. History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for patients with previously-treated CNS metastases, who are asymptomatic and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug. CNS screening with computed tomography \[CT\] or magnetic resonance imaging \[MRI\] is required only if clinically indicated or if the subject has a history of CNS metastases.
3. Treatment with any of the following anti-cancer therapies:
* radiation therapy, surgery or tumour embolisation within 14 days prior to the first dose of pazopanib OR
* chemotherapy, biological therapy or investigational therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib.
The analgesic radiation therapy is allowed (the irradiated lesions won't be chosen as target lesions during the evaluation)
4. Any ongoing toxicity from prior anti-cancer therapy that is \> Grade 1 followed and/or progressing in severity, except alopecia.
5. Other uncontrolled severe medical conditions.
6. Presence of uncontrolled infection.
7. Clinically significant gastrointestinal abnormalities
* that may increase the risk for gastrointestinal bleeding.
* that may affect absorption of investigational product.
8. Poorly controlled hypertension \[defined as systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg\].
NB: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. BP must be re-assessed on two occasions at \> 1 hour interval; on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be \<140/90 mmHg for the subject to be eligible to the study.
9. History of any cardiovascular pathology within the past 6 months.
10. Corrected QT interval (QTcB) \> 480 msec using Bazett's formula.
11. History of cerebrovascular accident, including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT), within the past 6 months.
NB: Subjects with recent DVT treated with therapeutic anti-coagulating agents at least 6 weeks before inclusion are eligible.
12. Major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture or ulcer (procedures such as catheter placement are not considered to be major).
13. Evidence of active bleeding or bleeding diathesis.
14. Haemoptysis within 8 weeks before inclusion.
15. Platelet transfusion in the past 7 days.
16. Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels.
17. Concomitant bilirubin and AST/ALT elevations above ULN.
18. Treatment with anti-vitamin K (LMWH are allowed).
19. Inability or unwillingness to discontinue prohibited medications for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study.
20. Inability to swallow.
21. Pregnant or lactating woman
22. Impossibility to comply with protocol constraints
Minimum Eligible Age
18 Years
Maximum Eligible Age
90 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Sponsor Role
collaborator
Centre Leon Berard
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jean-Yves BLAY, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Léon Bérard, LYON, FRANCE
Locations
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Institut Bergonié
Bordeaux, , France
Site Status
Centre Georges François Leclerc
Dijon, , France
Site Status
Centre Oscar Lambret
Lille, , France
Site Status
Centre Léon Bérard
Lyon, , France
Site Status
Hôpital de la Timone
Marseille, , France
Site Status
Institut Paoli Calmette
Marseille, , France
Site Status
Centre Alexis Vautrin
Nancy, , France
Site Status
Institut de Cancérologie de l'Ouest
Nantes, , France
Site Status
Hôpital St Antoine
Paris, , France
Site Status
Hôpital Tenon
Paris, , France
Site Status
CHU de Reims
Reims, , France
Site Status
Institut Cancerologie Neuwirth
Saint-Priest-en-Jarez, , France
Site Status
Institut Gustave Roussy
Villejuif, , France
Site Status
Countries
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France
References
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Blay JY, Bonvalot S, Casali P, Choi H, Debiec-Richter M, Dei Tos AP, Emile JF, Gronchi A, Hogendoorn PC, Joensuu H, Le Cesne A, McClure J, Maurel J, Nupponen N, Ray-Coquard I, Reichardt P, Sciot R, Stroobants S, van Glabbeke M, van Oosterom A, Demetri GD; GIST consensus meeting panelists. Consensus meeting for the management of gastrointestinal stromal tumors. Report of the GIST Consensus Conference of 20-21 March 2004, under the auspices of ESMO. Ann Oncol. 2005 Apr;16(4):566-78. doi: 10.1093/annonc/mdi127.
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Casali PG, Jost L, Reichardt P, Schlemmer M, Blay JY; ESMO Guidelines Working Group. Gastrointestinal stromal tumors: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol. 2008 May;19 Suppl 2:ii35-8. doi: 10.1093/annonc/mdn080. No abstract available.
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BACKGROUND
Demetri GD, Benjamin RS, Blanke CD, Blay JY, Casali P, Choi H, Corless CL, Debiec-Rychter M, DeMatteo RP, Ettinger DS, Fisher GA, Fletcher CD, Gronchi A, Hohenberger P, Hughes M, Joensuu H, Judson I, Le Cesne A, Maki RG, Morse M, Pappo AS, Pisters PW, Raut CP, Reichardt P, Tyler DS, Van den Abbeele AD, von Mehren M, Wayne JD, Zalcberg J; NCCN Task Force. NCCN Task Force report: management of patients with gastrointestinal stromal tumor (GIST)--update of the NCCN clinical practice guidelines. J Natl Compr Canc Netw. 2007 Jul;5 Suppl 2:S1-29; quiz S30.
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DeMatteo RP, Lewis JJ, Leung D, Mudan SS, Woodruff JM, Brennan MF. Two hundred gastrointestinal stromal tumors: recurrence patterns and prognostic factors for survival. Ann Surg. 2000 Jan;231(1):51-8. doi: 10.1097/00000658-200001000-00008.
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Rubin BP, Singer S, Tsao C, Duensing A, Lux ML, Ruiz R, Hibbard MK, Chen CJ, Xiao S, Tuveson DA, Demetri GD, Fletcher CD, Fletcher JA. KIT activation is a ubiquitous feature of gastrointestinal stromal tumors. Cancer Res. 2001 Nov 15;61(22):8118-21.
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Heinrich MC, Corless CL, Duensing A, McGreevey L, Chen CJ, Joseph N, Singer S, Griffith DJ, Haley A, Town A, Demetri GD, Fletcher CD, Fletcher JA. PDGFRA activating mutations in gastrointestinal stromal tumors. Science. 2003 Jan 31;299(5607):708-10. doi: 10.1126/science.1079666. Epub 2003 Jan 9.
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Blay JY, Le Cesne A, Ray-Coquard I, Bui B, Duffaud F, Delbaldo C, Adenis A, Viens P, Rios M, Bompas E, Cupissol D, Guillemet C, Kerbrat P, Fayette J, Chabaud S, Berthaud P, Perol D. Prospective multicentric randomized phase III study of imatinib in patients with advanced gastrointestinal stromal tumors comparing interruption versus continuation of treatment beyond 1 year: the French Sarcoma Group. J Clin Oncol. 2007 Mar 20;25(9):1107-13. doi: 10.1200/JCO.2006.09.0183.
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Verweij J, Casali PG, Zalcberg J, LeCesne A, Reichardt P, Blay JY, Issels R, van Oosterom A, Hogendoorn PC, Van Glabbeke M, Bertulli R, Judson I. Progression-free survival in gastrointestinal stromal tumours with high-dose imatinib: randomised trial. Lancet. 2004 Sep 25-Oct 1;364(9440):1127-34. doi: 10.1016/S0140-6736(04)17098-0.
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Blanke CD, Rankin C, Demetri GD, Ryan CW, von Mehren M, Benjamin RS, Raymond AK, Bramwell VH, Baker LH, Maki RG, Tanaka M, Hecht JR, Heinrich MC, Fletcher CD, Crowley JJ, Borden EC. Phase III randomized, intergroup trial assessing imatinib mesylate at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumors expressing the kit receptor tyrosine kinase: S0033. J Clin Oncol. 2008 Feb 1;26(4):626-32. doi: 10.1200/JCO.2007.13.4452.
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Blanke CD, Demetri GD, von Mehren M, Heinrich MC, Eisenberg B, Fletcher JA, Corless CL, Fletcher CD, Roberts PJ, Heinz D, Wehre E, Nikolova Z, Joensuu H. Long-term results from a randomized phase II trial of standard- versus higher-dose imatinib mesylate for patients with unresectable or metastatic gastrointestinal stromal tumors expressing KIT. J Clin Oncol. 2008 Feb 1;26(4):620-5. doi: 10.1200/JCO.2007.13.4403.
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Heinrich MC, Maki RG, Corless CL, Antonescu CR, Harlow A, Griffith D, Town A, McKinley A, Ou WB, Fletcher JA, Fletcher CD, Huang X, Cohen DP, Baum CM, Demetri GD. Primary and secondary kinase genotypes correlate with the biological and clinical activity of sunitinib in imatinib-resistant gastrointestinal stromal tumor. J Clin Oncol. 2008 Nov 20;26(33):5352-9. doi: 10.1200/JCO.2007.15.7461. Epub 2008 Oct 27.
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BACKGROUND
Kumar R, Knick VB, Rudolph SK, Johnson JH, Crosby RM, Crouthamel MC, Hopper TM, Miller CG, Harrington LE, Onori JA, Mullin RJ, Gilmer TM, Truesdale AT, Epperly AH, Boloor A, Stafford JA, Luttrell DK, Cheung M. Pharmacokinetic-pharmacodynamic correlation from mouse to human with pazopanib, a multikinase angiogenesis inhibitor with potent antitumor and antiangiogenic activity. Mol Cancer Ther. 2007 Jul;6(7):2012-21. doi: 10.1158/1535-7163.MCT-07-0193.
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BACKGROUND
Sternberg CN, Davis ID, Mardiak J, Szczylik C, Lee E, Wagstaff J, Barrios CH, Salman P, Gladkov OA, Kavina A, Zarba JJ, Chen M, McCann L, Pandite L, Roychowdhury DF, Hawkins RE. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol. 2010 Feb 20;28(6):1061-8. doi: 10.1200/JCO.2009.23.9764. Epub 2010 Jan 25.
Reference Type
BACKGROUND
Hutson TE, Davis ID, Machiels JP, De Souza PL, Rottey S, Hong BF, Epstein RJ, Baker KL, McCann L, Crofts T, Pandite L, Figlin RA. Efficacy and safety of pazopanib in patients with metastatic renal cell carcinoma. J Clin Oncol. 2010 Jan 20;28(3):475-80. doi: 10.1200/JCO.2008.21.6994. Epub 2009 Dec 14.
Reference Type
BACKGROUND
Mir O, Cropet C, Toulmonde M, Cesne AL, Molimard M, Bompas E, Cassier P, Ray-Coquard I, Rios M, Adenis A, Italiano A, Bouche O, Chauzit E, Duffaud F, Bertucci F, Isambert N, Gautier J, Blay JY, Perol D; PAZOGIST study group of the French Sarcoma Groupe-Groupe d'Etude des Tumeurs Osseuses (GSF-GETO). Pazopanib plus best supportive care versus best supportive care alone in advanced gastrointestinal stromal tumours resistant to imatinib and sunitinib (PAZOGIST): a randomised, multicentre, open-label phase 2 trial. Lancet Oncol. 2016 May;17(5):632-41. doi: 10.1016/S1470-2045(16)00075-9. Epub 2016 Apr 5.
Reference Type
DERIVED
Other Identifiers
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PAZOGIST
Identifier Type: -
Identifier Source: org_study_id
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NOT_YET_RECRUITING
PHASE2
DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumor (GIST)
NCT04276415
TERMINATED
PHASE1
A Study of Nilotinib Versus Imatinib in GIST Patients
NCT00785785
COMPLETED
PHASE3
Rivoceranib Plus Paclitaxel in Patients With Gastrointestinal Stromal Tumor
NCT05905887
RECRUITING
PHASE2
Tasigna Neoadjuvant Gastrointestinal Stromal Tumor (GIST)
NCT01270893
WITHDRAWN
PHASE2
Ripretinib Used for Resectable Metastatic GIST After Failure of Imatinib Therapy
NCT05132738
UNKNOWN
NA
Efficacy of Nilotinib in Adult Patients With Gastrointestinal Stromal Tumors Resistant to Imatinib and Sunitinib.
NCT01289028
COMPLETED
PHASE3
A Study to Evaluate Rivoceranib Plus Best Supportive Care Compared to Placebo Plus Best Supportive Care in Participants With Gastric Cancer
NCT03042611
COMPLETED
PHASE3
French Long Term Registry With Longitudinal Follow up of PDGFRA D842V-GIST Patients
NCT04927260
ACTIVE_NOT_RECRUITING
An Efficacy Study in Gastric and Gastroesophageal Junction Cancer Comparing Ipilimumab Versus Standard of Care Immediately Following First Line Chemotherapy
NCT01585987
COMPLETED
PHASE2
PDR001 Plus Imatinib for Metastatic or Unresectable GIST
NCT03609424
COMPLETED
PHASE1/PHASE2
Phase II Study Aiming to Evaluate the Efficacy and Safety of Nilotinib Patients With Gastrointestinal Stromal Tumors (GIST) Resistant or Intolerant to Imatinib and or to 2nd Line Tyrosine Kinas (TK) Inhibitor
NCT00633295
COMPLETED
PHASE2
Efficacy and Safety of Anlotinib in Patients With Advanced Gastrointestinal Stromal Tumor After Failure of Imatinib: a Prospective, Single Arm and Multicenter Trial
NCT04106024
UNKNOWN
PHASE2
Nivolumab With or Without Ipilimumab in Treating Patients With Gastrointestinal Stromal Tumor That Is Metastatic or Cannot Be Removed by Surgery
NCT02880020
COMPLETED
PHASE2
A Study of DCC-2618 (Ripretinib) In Patients With With Advanced Gastrointestinal Stromal Tumors (GIST)
NCT04282980
COMPLETED
PHASE2
(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors
NCT05208047
ACTIVE_NOT_RECRUITING
PHASE3
First-in-human Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors
NCT05489237
RECRUITING
PHASE1
Efficacy and Safety of AMN107 in Patients With GastroIntestinal Stromal Tumors (GIST) Who Have Failed Both Imatinib and Sunitinib
NCT00718562
COMPLETED
PHASE2
Treatment of Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line With Nilotinib
NCT00756509
COMPLETED
PHASE4
Ph II of Capecitabine, Carboplatin & Bevacizumab for Gastroesophageal Junction & Gastric Carcinoma
NCT00780494
COMPLETED
PHASE2
Efficacy of Irinotecan and Capecitabine Versus(vs) Cisplatin and Capecitabine in Patients With Esophago-Gastric Cancer
NCT00675194
COMPLETED
PHASE2
A Study of Pazopanib With CAPEOX in AGC Patients
NCT01130805
COMPLETED
PHASE2