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Study of Efficacy, Safety, and Quality of Life of Pazopanib in Patients With Advanced and/or Metastatic Renal Cell Carcinoma After Prior Checkpoint Inhibitor Treatment (IO-PAZ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03200717
Recruitment Status : Active, not recruiting
First Posted : June 27, 2017
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Renal Cell Carcinoma Metastatic Renal Cell Carcinoma Drug: pazopanib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 14, 2017
Actual Primary Completion Date : December 18, 2019
Estimated Study Completion Date : July 15, 2021


Arm Intervention/treatment
Experimental: pazopanib 800 mg
administered after checkpoint inhibitor treatment
Drug: pazopanib

Pazopanib is taken orally and will be administered daily as a fixed dose. Enrollment of 3rd-line patients will be restricted to ensure approximately 40 patients receive pazopanib as 2nd-line therapy.

Number of Cycles: until progression, unacceptable toxicity develops, death, pregnancy, start of new anti-cancer therapy, doctor/patient discontinuation, lost to follow-up, end of study, or study termination by sponsor.





Primary Outcome Measures :
  1. 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 ]
    Progression free survival (PFS) is defined as the time from the start date of pazopanib treatment to the date of the first documented progression or death due to any cause. PFS will be assessed via local review according to RECIST 1.1.


Secondary Outcome Measures :
  1. 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) ]
    Overall response rate defined as the proportion of patients with best overall response of confirmed complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST v1.1 Clinical benefit rate defined as the proportion of patients with a best overall response of CR or PR or an overall lesion response of stable disease (SD), or Non-CR/Non-PD lasting ≥ 24 weeks based on local investigator's assessment according to RECIST v1.1.

  2. 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) ]
    Overall survival defined as the time from the first administration of study treatment until death due to any cause

  3. 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) ]
    Duration of response defined as the time from the date of first documented response (confirmed CR or PR) to the date of tumor progression

  4. 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) ]
    Type, frequency and severity of adverse events per NCI-CTCAE v4.03 and type, frequency and severity of laboratory toxicities per NCI-CTCAE v4.03 will be summarized.

  5. Change from baseline in FSKI-DRS score [ Time Frame: From baseline until the end of study (~36 months from FPFV) ]

    Quality of life measured through the Functional Assessment of Cancer Therapy- Kidney Symptom Index (FSKI-DRS).

    FKSI-DRS is a validated tool developed specifically to assess symptoms experienced by patients with advanced kidney cancer. The symptoms covered by the 9-item FKSI-DRS include fatigue, pain, weight loss, dyspnea, cough, fever and hematuria. The FKSI-DRS will be scored according to the developers' instructions.


  6. Change from baseline in EQ-5D-5L score [ Time Frame: From baseline until the end of study (~36 months from FPFV) ]
    Quality of life measured through the EQ-5D-5L questionnaire. The EQ-5D-5L is a general health status and health utility measure. It measures 5 dimensions of health state: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression each assessed by a single question on a five point ordinal scale. Descriptive statistics will be used to summarize the scored scales at each scheduled assessment time point. Additionally, changes from baseline in the scores at the time of each assessment will be descriptively analyzed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%.
  • Patient must have potassium, sodium, calcium and magnesium within normal limits of the central laboratory

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 <Grade 1.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200717


Locations
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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Argentina
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1280AEB
Austria
Novartis Investigative Site
Graz, Austria, 8036
Novartis Investigative Site
Salzburg, Austria, 5020
Novartis Investigative Site
Wien, Austria, A-1090
Canada, Alberta
Novartis Investigative Site
Calgary, Alberta, Canada, T2N 4N2
Chile
Novartis Investigative Site
Temuco, Araucania, Chile, 4810469
Novartis Investigative Site
Santiago, Chile, 8420383
Czechia
Novartis Investigative Site
Brno, Czech Republic, Czechia, 656 53
Novartis Investigative Site
Olomouc, CZE, Czechia, 775 20
France
Novartis Investigative Site
Paris, France, 75015
Novartis Investigative Site
Saint Herblain cedex, France, 44805
Novartis Investigative Site
Strasbourg Cedex, France, F 67098
Novartis Investigative Site
Valenciennes, France, 59300
Germany
Novartis Investigative Site
Hamburg, Germany, 20246
Novartis Investigative Site
Hannover, Germany, 30625
Novartis Investigative Site
Jena, Germany, 07740
Novartis Investigative Site
Tübingen, Germany, 72076
Hungary
Novartis Investigative Site
Budapest, Hungary, H 1122
Spain
Novartis Investigative Site
Sevilla, Andalucia, Spain, 41013
Novartis Investigative Site
Valencia, Comunidad Valenciana, Spain, 46009
Novartis Investigative Site
Madrid, Spain, 28041
United Kingdom
Novartis Investigative Site
London, United Kingdom, NW3 2QG
Novartis Investigative Site
Manchester, United Kingdom, M20 2BX
Novartis Investigative Site
Preston, United Kingdom, PR2 9HT
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03200717    
Other Study ID Numbers: CPZP034A2410
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
renal cell carcinoma
metastatic renal cell
pazopanib
checkpoint inhibitor therapy
RCC
hypernephroma
renal adenocarcinoma
kidney cancer
renal cancer
adult
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases