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Savolitinib vs. Sunitinib in MET-driven PRCC.

AstraZeneca logo

AstraZeneca

Status and phase

Active, not recruiting
Phase 3

Conditions

Carcinoma, Renal Cell
Kidney Diseases
Protein Kinase Inhibitors
Neoplasms by Site
Kidney Neoplasms
Carcinoma
Enzyme Inhibitors
Urologic Neoplasms

Treatments

Drug: Savolitinib
Drug: Sunitinib

Study type

Interventional

Funder types

Industry
Other

Identifiers

NCT03091192
2016-004108-73 (EudraCT Number)
D5082C00003

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 130 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Savolitinib
Experimental group
Description:
See: intervention description
Treatment:
Drug: Savolitinib
Sunitinib
Active Comparator group
Description:
See: intervention description
Treatment:
Drug: Sunitinib

Trial documents
2

Trial contacts and locations

59

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Data sourced from clinicaltrials.gov

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