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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03091192
Other study ID # D5082C00003
Secondary ID 2016-004108-73
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date July 25, 2017
Est. completion date December 31, 2024

Study information

Verified date April 2024
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date December 31, 2024
Est. primary completion date August 18, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 130 Years
Eligibility Inclusion Criteria: 1. 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. 2. 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 3. 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 4. Adequate haematological, renal, cardiac and liver functions 5. Karnofsky performance status = 80 Exclusion Criteria: 1. 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. 2. Prior treatment with a MET inhibitor (e.g. foretinib, crizotinib, cabozantinib, onartuzumab or previous savolitinib) or sunitinb. 3. 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). 4. Wide field radiotherapy administered =28 days or limited field radiation for palliation =7 days prior to the date of randomisation 5. Major surgical procedures =28 days of randomisation or minor surgical procedures =7 days. No waiting is required following port-a-cath placement. 6. Previously untreated brain metastases 7. Serious active infection or gastrointestinal disease 8. Presence of other active cancers, or history of treatment for invasive cancer within the last 5 years. 9. 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 Design


Intervention

Drug:
Savolitinib
600 mg (400 mg if <50 kg) by mouth (PO) with a meal once daily (QD), continuously
Sunitinib
50 mg by mouth (PO) once daily (QD), with or w/o food, 4 weeks on/2weeks off

Locations

Country Name City State
Brazil Research Site Barretos
Brazil Research Site Curitiba
Brazil Research Site Passo Fundo
Brazil Research Site Pelotas
Brazil Research Site Porto Alegre
Brazil Research Site Porto Alegre
Brazil Research Site Porto Alegre
Brazil Research Site Rio de Janeiro
Brazil Research Site São José do Rio Preto
Brazil Research Site Sao Paulo
Brazil Research Site São Paulo
France Research Site Bordeaux
France Research Site Vandoeuvre les Nancy
France Research Site Villejuif
Italy Research Site Arezzo
Italy Research Site Meldola
Italy Research Site Milano
Italy Research Site Modena
Italy Research Site Orbassano
Italy Research Site Pavia
Italy Research Site Roma
Korea, Republic of Research Site Daejeon
Korea, Republic of Research Site Goyang-si
Korea, Republic of Research Site Hwasun-gun
Korea, Republic of Research Site Incheon
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Russian Federation Research Site Krasnoyarsk
Russian Federation Research Site Moscow
Russian Federation Research Site Moscow
Russian Federation Research Site Moscow
Russian Federation Research Site Moscow
Russian Federation Research Site Murmansk
Russian Federation Research Site Nizhnii Novgorod
Russian Federation Research Site Obninsk
Russian Federation Research Site Omsk
Russian Federation Research Site Saint Petersburg
Russian Federation Research Site Sankt-Peterburg
Russian Federation Research Site St. Petersburg
Russian Federation Research Site Volgograd
Ukraine Research Site Dnipro
Ukraine Research Site Dnipro
Ukraine Research Site Ivano-Frankivsk
Ukraine Research Site Kharkiv Region
Ukraine Research Site Kyiv
Ukraine Research Site Kyiv
Ukraine Research Site Odesa
Ukraine Research Site Sumy
United States Research Site Atlanta Georgia
United States Research Site Boston Massachusetts
United States Research Site Chicago Illinois
United States Research Site Iowa City Iowa
United States Research Site Kansas City Missouri
United States Research Site La Jolla California
United States Research Site Nashville Tennessee
United States Research Site New York New York

Sponsors (2)

Lead Sponsor Collaborator
AstraZeneca Hutchinson MediPharma (HMP)

Countries where clinical trial is conducted

United States,  Brazil,  France,  Italy,  Korea, Republic of,  Russian Federation,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of randomisation until the date of PD (defined by Recist 1.1 and confirmed by BICR) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression. RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.
Secondary Overall Survival (OS) Time between the date of randomisation and the date of death due to any cause. RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.
Secondary Objective Response Rate (ORR) by BICR Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR prior to progression or any further therapy. RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.
Secondary Duration of Response (DoR) by BICR Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR is the time from the date of first documented response until the date of documented progression or death in the absence of disease progression. RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.
Secondary Disease Control Rate (DCR) at 6 Months by BICR Disease control rate at 6 months is defined as the percentage of patients who have a best objective response of Complete Response or Partial Response in that period or who have demonstrated Stable Disease for a minimum interval of 23 weeks. RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.
Secondary Disease Control Rate (DCR) at 12 Months by BICR Disease control rate at 12 months is defined as the percentage of patients who have a best objective response of complete responses or partial responses in that period or who have demonstrated stable disease for a minimum interval of 47 weeks. RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.
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