Kidney Cancer Clinical Trial

Savolitinib vs. Sunitinib in MET-driven PRCC.

Summary

This study is designed for patients diagnosed with MET-driven, unresectable and locally advanced or metastatic Papillary Renal Cell Carcinoma. The purpose of this study is to see if an investigational new anti-cancer medication, savolitinib, is effective in treating patients with MET-driven PRCC, how it compares with another medication frequently used to treat this disease called sunitinib, and what side effects it might cause.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed PRCC, which is unresectable/locally advanced or metastatic with measurable disease as per RECIST 1.1. Patients with papillary urothelial carcinoma or renal pelvis cancer of the kidney are not considered PRCC and are not eligible.
Confirmation of MET-driven PRCC without co-occurring FH or VHL mutations from an FFPE tumour sample using the sponsor-designated central laboratory validated NGS assay
Patients who have received no prior systemic therapy as well as those who have received prior systemic therapy for PRCC in the advanced setting.* Patients can be treatment-naïve, or previously treated, but cannot have previously received sunitinib or a MET inhibitor. Patients who have received prior systemic therapy must have had disease progression in soft tissue disease or bone within 6 months of the last dose of the most recent systemic therapy
Adequate haematological, renal, cardiac and liver functions
Karnofsky performance status ≥ 80

Exclusion Criteria:

Most recent cytotoxic chemotherapy, immunotherapy, chemo-immunotherapy, or investigational agents <28 days from the date of randomisation. Most recent non cytotoxic targeted therapy <14 days from the date of randomisation.
Prior treatment with a MET inhibitor (e.g. foretinib, crizotinib, cabozantinib, onartuzumab or previous savolitinib) or sunitinb.
Treatment with strong inducers or inhibitors of CYP3A4 or strong inhibitors of CYP1A2, taken within 2 weeks or not possible to be stopped for at least 2 week before the date of randomisation. Herbal medications cannot be taken within 7 days of the date of randomisation (3 weeks for St John's wort).
Wide field radiotherapy administered ≤28 days or limited field radiation for palliation ≤7 days prior to the date of randomisation
Major surgical procedures ≤28 days of randomisation or minor surgical procedures ≤7 days. No waiting is required following port-a-cath placement.
Previously untreated brain metastases
Serious active infection or gastrointestinal disease
Presence of other active cancers, or history of treatment for invasive cancer within the last 5 years.
Mean resting QTcF >470 msec for women and >450 msec for men on the Part 2 screening triplicate ECGs or factors that may increase the risk of QTcF prolongation such as chronic hypokalaemia not correctable with supplements, congenital or familial long QT syndrome, or family history of unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

60

Study ID:

NCT03091192

Recruitment Status:

Active, not recruiting

Sponsor:

AstraZeneca

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There are 59 Locations for this study

See Locations Near You

Research Site
La Jolla California, 92093, United States
Research Site
Atlanta Georgia, 30322, United States
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Chicago Illinois, 60637, United States
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Iowa City Iowa, 52242, United States
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Boston Massachusetts, 02215, United States
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Kansas City Missouri, 64132, United States
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New York New York, 10021, United States
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Nashville Tennessee, 37203, United States
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Barretos , 14784, Brazil
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Curitiba , 81520, Brazil
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Passo Fundo , 99010, Brazil
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Pelotas , 09601, Brazil
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Porto Alegre , 90050, Brazil
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Porto Alegre , 90610, Brazil
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Porto Alegre , 91350, Brazil
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Rio de Janeiro , 22793, Brazil
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Sao Paulo , 01323, Brazil
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São José do Rio Preto , 15090, Brazil
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São Paulo , 01246, Brazil
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Bordeaux , 33000, France
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Vandoeuvre les Nancy , 54519, France
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Villejuif , 94805, France
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Arezzo , 52100, Italy
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Meldola , 47014, Italy
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Milano , 20133, Italy
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Modena , 41100, Italy
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Orbassano , 10043, Italy
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Pavia , 27100, Italy
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Roma , 00152, Italy
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Daejeon , 35015, Korea, Republic of
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Goyang-si , 10408, Korea, Republic of
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Hwasun-gun , 58128, Korea, Republic of
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Incheon , 21565, Korea, Republic of
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Seoul , 03080, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Seoul , 06273, Korea, Republic of
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Seoul , 120-7, Korea, Republic of
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Seoul , 6351, Korea, Republic of
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Krasnoyarsk , 66013, Russian Federation
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Moscow , 10507, Russian Federation
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Moscow , 11547, Russian Federation
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Moscow , 11552, Russian Federation
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Moscow , RU-12, Russian Federation
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Murmansk , 18304, Russian Federation
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Nizhnii Novgorod , 60310, Russian Federation
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Obninsk , 24903, Russian Federation
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Omsk , 64401, Russian Federation
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Saint Petersburg , 19527, Russian Federation
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Sankt-Peterburg , 19660, Russian Federation
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St. Petersburg , 19401, Russian Federation
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Volgograd , 40013, Russian Federation
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Dnipro , 49005, Ukraine
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Dnipro , 49102, Ukraine
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Ivano-Frankivsk , 76018, Ukraine
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Kharkiv Region , 61070, Ukraine
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Kyiv , 03022, Ukraine
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Kyiv , 03115, Ukraine
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Odesa , 65055, Ukraine
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Sumy , 40022, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

60

Study ID:

NCT03091192

Recruitment Status:

Active, not recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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