A Phase II Trial to Evaluate the Efficacy of AZD6094 (HMPL-504) in Patients With Papillary Renal Cell Carcinoma (PRCC)
Condition: Papillary Renal Cell Cancer
MeSH terms: Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label, single-arm, multicentre, global, phase II study designed to evaluate
      the efficacy and safety of AZD6094 in patients with papillary renal cell carcinoma (PRCC) who
      are treatment naïve or previously treated.

      An independent central pathology review of tumour samples will be used to confirm the
      diagnosis of PRCC of all patients enrolling. However, locally available pathology results
      confirming PRCC will be allowed for timely study entry.
    

Detailed description: 
      The study will comprise two stages. In Stage 1 approximately 20 patients will be enrolled.
      This group is considered sufficient to provide preliminary assessment of the anti-tumour
      activity of AZD6094 in the form of non-binding futility analysis.

      If ≤ 2 tumour responses are observed in the first 20 evaluable patients termination of the
      study will be considered taking into account the relevant molecular profile of the patients
      and additional information from related studies in the drug development programme.

      All patients entering the study will take AZD6094 600 mg by mouth (PO) once daily (QD).
      Treatment will be given continuously.

      Following the baseline assessment, efficacy will be assessed by objective tumour assessments
      every 6 weeks (±7 days), for the first 12 months and every 12 weeks thereafter until
      objective disease progression as defined by RECIST v1.1 There will be a data cut-off after
      all patients have completed at least 12 weeks of treatment with AZD6094 or withdrawn. The
      database will be locked and data analysis will be performed on this dataset.

      Any patients still receiving study drug at the time of data cut-off will be able to continue
      to receive AZD6094 while deriving clinical benefit. Such patients will continue to be
      monitored for the occurrence of serious adverse events up to 28 days after the last dose of
      AZD6094.

      After database lock (DBL) tumour assessments will be performed every 12 weeks (±7 days) until
      objective disease progression as defined by RECIST v1.1.

      Patients discontinuing treatment due to documented disease progression will enter a survival
      follow-up period, where they will be followed for the initiation of subsequent anti-cancer
      therapies every 3 months until death, loss to follow-up or withdrawal of consent, whichever
      comes first.

      Patients discontinuing treatment prior to documented disease progression will enter a
      progression-free survival follow-up period where they will continue to have disease
      assessments every 6 weeks (±7 days) for the first 12 months of follow-up and every 12 weeks
      thereafter until objective disease progression as defined by RECIST v1.1, death, loss to
      follow-up or withdrawal of consent, whichever comes first. After DBL, tumour assessments will
      be performed in the progression free survival patient population every 12 weeks (±7 days)
      until objective disease progression as defined by RECIST v1.1
    

Intervention name(s): AZD6094
Intervention type(s): Drug
Intervention description(s): AZD6094 is a potent and selective small molecule mesenchymal epithelial transition (c-MET) kinase inhibitor.
Other intervention name(s): Savolitinib; HMPL - 504
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AZD6094; Savolitinib; Papillary Renal Cell Cancer