A Prospective International Multicenter Phase II Study to Evaluate the Efficacy, Safety and Quality of Life of Pazopanib in Patients With Advanced and/or Metastatic Renal Cell Carcinoma After Previous Therapy With Checkpoint Inhibitor Treatment

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A Prospective International Multicenter Phase II Study to Evaluate the Efficacy, Safety and Quality of Life of Pazopanib in Patients With Advanced and/or Metastatic Renal Cell Carcinoma After Previous Therapy With Checkpoint Inhibitor Treatment

Condition: Advanced Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma

Intervention:

  • Drug: pazopanib

Purpose: An international, multicenter, single arm Phase II trial to determine the efficacy, safety and quality of life of pazopanib treatment after previous therapy with immune checkpoint treatment. Approximately 100 patients will be enrolled, with approximately 40 of those patients receiving pazopanib as 2nd-line therapy. Patients will receive treatment with standard dose pazopanib until disease progression, unacceptable toxicity, pregnancy, death, discontinuation from the study treatment for any other reason or until study end. All patients will be followed for survival. Patients who discontinue treatment without documented disease progression will be followed for efficacy.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03200717

Sponsor: Novartis Pharmaceuticals

Primary Outcome Measures:

  • Measure: Progression free survival based on local investigator assessment
  • Time Frame: Date of first treatment to date of progression or death up to approximately 36 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Overall response rate and clinical benefit rate based on local investigator assessment
  • Time Frame: After all patients have received a minimum of 6 cycles of study treatment or have discontinued study treatment early (note: 1 cycle = 28 days) and at the end of the study (~36 months from FPFV)
  • Safety Issue:
  • Measure: Overall survival
  • Time Frame: After all patients have received a minimum of 6 cycles of study treatment or have discontinued study treatment early (note: 1 cycle = 28 days) and at the end of the study (~36 months from FPFV)
  • Safety Issue:
  • Measure: Duration of response in patients with confirmed complete response or partial response
  • Time Frame: After all patients have received a minimum of 6 cycles of study treatment or have discontinued study treatment early (note: 1 cycle = 28 days) and at the end of the study (~36 months from FPFV)
  • Safety Issue:
  • Measure: Incidence of Treatment-emergent Adverse Events (safety and tolerability)
  • Time Frame: After all patients have received a minimum of 6 cycles of study treatment or have discontinued study treatment early (note: 1 cycle = 28 days) and at the end of the study (~36 months from FPFV)
  • Safety Issue:
  • Measure: Change from baseline in FSKI-DRS score
  • Time Frame: From baseline to Cycle 2, 3, 4, 5, 6, 7, 9, 11, 13 and every 3rd cycle thereafter until the end of study (~36 months from FPFV)
  • Safety Issue:
  • Measure: Change from baseline in EQ-5D-5L score
  • Time Frame: From baseline to Cycle 2, 3, 4, 5, 6, 7, 9, 11, 13 and every 3rd cycle thereafter until the end of study (~36 months from FPFV)
  • Safety Issue:

Estimated Enrollment: 100

Study Start Date: November 14, 2017

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Patient is ≥ 18 years old at the time of informed consent.
  • Patient has histologically confirmed locally recurrent or metastatic predominantly clear cell renal cell carcinoma.
  • Patient must have measurable disease based on RECIST 1.1 criteria
  • Patient must have received prior systemic therapy with an immune checkpoint inhibitor (monotherapy or combination) as 1st or 2nd line RCC treatment. Note: patients with prior mTOR inhibitor or TKI treatment as monotherapy or in combination with immune checkpoint inhibitor are allowed; however, treatment with immune checkpoint inhibitor (monotherapy or in combination) must have been the last treatment prior to study entry.
  • Last dose of immune checkpoint inhibitor therapy must have been received 4 or more weeks before start of study treatment
  • Patient must have a Karnofsky performance status ≥70%.

Exclusion Criteria:

  • Renal cell carcinoma without any clear (conventional) cell component
  • History or evidence of central nervous system (CNS) metastases (patients with pretreated metastases are eligible under certain conditions)
  • Prior treatment with pazopanib
  • Prior treatment with bevacizumab that was not given in combination with immune checkpoint inhibitor therapy.
  • Prior treatment with more than 2 lines of therapy (combination treatments are considered 1 line of therapy)
  • Patient has not recovered from toxicity from prior immune checkpoint inhibitor therapy. Recovery is defined as ≤ NCI-CTCAE Grade 1, except for liver function test levels which must be < li>
  • Disease recurrence less than 6 months from the last dose of prior neoadjuvant or adjuvant therapy (including VEGF-R TKI)
  • Patients receiving prohibited concomitant medications that cannot be discontinued or replaced by safe alternative medication at least 5 half-lives of the concomitant medication or 7 days, whichever is longer, prior to the start of pazopanib treatment.
  • Administration of any investigational drug within 4 weeks prior to the first dose of study treatment

Contact:

  • Novartis Pharmaceuticals
  • 1-888-669-6682

Locations:

  • Hackensack Univ Medical Ctr – John Theurer Cancer Ctr
  • Hackensack New Jersey 07601 United States
  • Roswell Park Cancer Institute
  • Buffalo New York 14263 United States
  • Novartis Investigative Site
  • Caba Buenos Aires C1280AEB Argentina
  • Novartis Investigative Site
  • Caba Buenos Aires C1426ANZ Argentina
  • Novartis Investigative Site
  • Rosario Sante Fe S200KZE Argentina
  • Novartis Investigative Site
  • Graz 8036 Austria
  • Novartis Investigative Site
  • Salzburg 5020 Austria
  • Novartis Investigative Site
  • Wien A-1090 Austria
  • Novartis Investigative Site
  • Calgary Alberta T2N 4N2 Canada
  • Novartis Investigative Site
  • Temuco Araucania 4810469 Chile
  • Novartis Investigative Site
  • Santiago 8420383 Chile
  • Novartis Investigative Site
  • Brno Czech Republic 656 53 Czechia
  • Novartis Investigative Site
  • Olomouc CZE 775 20 Czechia
  • Novartis Investigative Site
  • Paris 75015 France
  • Novartis Investigative Site
  • Quimper 29107 France
  • Novartis Investigative Site
  • Saint Herblain cedex 44805 France
  • Novartis Investigative Site
  • Strasbourg Cedex 67091 France
  • Novartis Investigative Site
  • Valenciennes 59300 France
  • Novartis Investigative Site
  • Berlin 10117 Germany
  • Novartis Investigative Site
  • Dresden 01307 Germany
  • Novartis Investigative Site
  • Erlangen 91054 Germany
  • Novartis Investigative Site
  • Greifswald 17487 Germany
  • Novartis Investigative Site
  • Hamburg 20246 Germany
  • Novartis Investigative Site
  • Hannover 30625 Germany
  • Novartis Investigative Site
  • Jena 07740 Germany
  • Novartis Investigative Site
  • Leipzig 04103 Germany
  • Novartis Investigative Site
  • Muenster 48149 Germany
  • Novartis Investigative Site
  • Tübingen 72076 Germany
  • Novartis Investigative Site
  • Budapest H 1122 Hungary
  • Novartis Investigative Site
  • Sevilla Andalucia 41013 Spain
  • Novartis Investigative Site
  • Valencia Comunidad Valenciana 46009 Spain
  • Novartis Investigative Site
  • Caceres Extremadura 10003 Spain
  • Novartis Investigative Site
  • Leon 24071 Spain
  • Novartis Investigative Site
  • Madrid 28041 Spain
  • Novartis Investigative Site
  • Madrid 28046 Spain
  • Novartis Investigative Site
  • London NW3 2QG United Kingdom
  • Novartis Investigative Site
  • Manchester M20 2BX United Kingdom
  • Novartis Investigative Site
  • Preston PR2 9HT United Kingdom

View trial on ClinicalTrials.gov

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