SWOG clinical trial number
S1500

A Randomized, Phase II Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005], Savolitinib [NSC #785348], and Sunitinib [NSC #736511])in Metastatic Papillary Renal Carcinoma (PAPMET)

Closed
Phase
II
Accrual
100%
Abbreviated Title
PhII: MET inhibitors for papillary RCC
Status Notes
Arms 3 and 4 of the study referenced above are permanently closed to accrual effective 12/5/18. Arms 1 and 2 are active to accrual effective 1/22/19.

Activated
04/05/2016
Participants
ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Research committees

Genitourinary Cancer

Treatment

Sunitinib Cabozantinib Crizotinib Savolitinib

Eligibility Criteria Expand/Collapse

Histologically or cytologically confirmed papillary histology renal cell carcinoma that is metastatic or locally advanced disease not amenable to surgical resection. Measurable disease. Eval for tumor measurement within 28 days prior to reg. Bone scan if suspicion for bone mets. No cavitating pulmonary lesions. No tumor invading the GI tract or evidence of endotracheal or endobronchial tumor within 28 days prior to reg. May have received prior surgery. May have received up to one prior systemic therapy for advanced or metastatic renal cell carcinoma with the exception of another VEGF inhibitor FDA-approved for advanced RCC. See Section 5.2.b for details. May have received prior radiation therapy but must have measurable disease outside the radiation port. Must not be taking strong CYP3A4 inhibitors, strong CYP3A4 inducers, potent inhibitors of CYP1A2, or drugs known to be CYP3A4 substrates with a narrow therapeutic range. Not receiving any other investigational agents. Within 28 days prior to reg: complete physical exam and medical history; adequate hematologic function; adequate hepatic function; adequate kidney function; echocardiogram; EKG; baseline urinalysis; electrolytes. Zubrod 0-1. No clinical evidence of CHF at reg. No unstable angina pectoris, clinically significant cardiac arrhythmias, or stroke within 3 months prior to reg. No myocardial infarction or thromboembolic event requiring anticoagulation with 6 months prior to reg. No inadequately controlled hypertension. Must be able to take orals meds. No clinically-significant GI bleeding within 6 months prior to reg. No GI disorder that bears a high risk of perforation or fistula. No hemoptysis within 3 months prior to reg. No signs of pulmonary hemorrhage within 3 months prior to reg. Imaging must not indicate the presence of tumor invading or encasing any major blood vessels. Not pregnant or nursing. No combination antiretroviral therapy. Must have tissue available and be willing to submit for central path review.

Publication Information Expand/Collapse

2021

A comparison of sunitinib with cabozantinib, crizotinib, and savolitinib for treatment of advanced papillary renal cell carcinoma: a randomised, open-label, phase 2 trial

S Pal;C Tangen;I Thompson;N Balzer-Haas;D George;D Heng;B Shuch;M Stein;M Tretiakova;P Humphrey;A Adeniran;V Narayan;G Bjarnason;U Vaishampayan;A Alva;T Zhang;S Cole;M Plets;J Wright;P Lara Lancet Feb 20;397(10275):695-703. doi: 10.1016/S0140-6736(21)00152-5. Epub 2021 Feb 13.

PMid: PMID33592176

Sunitinib versus cabozantinib, crizotinib or savolitinib in metastatic papillary renal cell carcinoma (pRCC): Results from the randomized phase II SWOG 1500 study

SK Pal;C Tangen;IM Thompson;N Balzer-Haas;D George;D Heng;B Shuch;M Stein;M Tretiakova;P Humphrey;A Adeniran;V Narayan;G Bjarnason;U Vaishampayan;A Alva;T Zhang;S Cole;M Plets;J Wright;P Lara J Clin Oncol 39, 2021 (suppl 6; abstr 270); ASCO GU Cancers Sympos (Feb 13-15, 2021), oral

2017

A randomized, phase II efficacy assessment of multiple MET kinase inhibitors (Cabozantinib [NSC #761968], crizotinib [NSC #749005], savolitinib [NSC #785348], and sunitinib [NSC #736511]) in metastatic papillary renal carcinoma (PAPMET): SWOG S1500, NCT02761057

S Pal;C Tangen;IM Thompson;B Shuch;N Balzer-Haas;DJ George;M Stein;M Plets;P Lara J Clin Oncol 35, 2017 (suppl; abstr TPS4599); American Society of Clinical Oncology Annual Meeting (June 2-6, 2017, Chicago, IL), poster session

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