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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)

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ClinicalTrials.gov Identifier: NCT03200717
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : May 21, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Estimated Primary Completion Date : July 29, 2019
Estimated Study Completion Date : February 26, 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 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) ]

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

    FKSI-DRS is a set of items selected which was developed and validated to specifically assess symptoms experienced by patients with advanced kidney cancer. Item development was conducted using both clinician and patient input to determine the 9 most important symptoms and concerns of people being treated for advanced kidney cancer. These 9 items were then validated by administering the symptom index to patients diagnosed 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 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) ]
    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 threepoint 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

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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%.

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


Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 Novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111 Novartis.email@novartis.com

Locations
Argentina
Novartis Investigative Site Recruiting
Caba, Buenos Aires, Argentina, C1280AEB
Austria
Novartis Investigative Site Recruiting
Graz, Austria, 8036
Novartis Investigative Site Recruiting
Salzburg, Austria, 5020
Novartis Investigative Site Recruiting
Wien, Austria, A-1090
Canada, Alberta
Novartis Investigative Site Recruiting
Calgary, Alberta, Canada, T2N 4N2
Chile
Novartis Investigative Site Recruiting
Temuco, Araucania, Chile, 4810469
Novartis Investigative Site Recruiting
Santiago, Chile, 8420383
Czechia
Novartis Investigative Site Recruiting
Brno, Czech Republic, Czechia, 656 53
Novartis Investigative Site Recruiting
Olomouc, CZE, Czechia, 775 20
Germany
Novartis Investigative Site Recruiting
Berlin, Germany, 10117
Novartis Investigative Site Recruiting
Dresden, Germany, 01307
Novartis Investigative Site Recruiting
Erlangen, Germany, 91054
Novartis Investigative Site Recruiting
Hamburg, Germany, 20246
Novartis Investigative Site Recruiting
Hannover, Germany, 30625
Novartis Investigative Site Recruiting
Jena, Germany, 07740
Novartis Investigative Site Recruiting
Leipzig, Germany, 04103
Novartis Investigative Site Recruiting
Muenster, Germany, 48149
Novartis Investigative Site Recruiting
Tübingen, Germany, 72076
Hungary
Novartis Investigative Site Recruiting
Budapest, Hungary, H-1122
Spain
Novartis Investigative Site Recruiting
Sevilla, Andalucia, Spain, 41013
Novartis Investigative Site Recruiting
Caceres, Extremadura, Spain, 10003
Novartis Investigative Site Recruiting
Leon, Spain, 24071
Novartis Investigative Site Recruiting
Madrid, Spain, 28041
Novartis Investigative Site Recruiting
Madrid, Spain, 28046
United Kingdom
Novartis Investigative Site Recruiting
London, United Kingdom, NW3 2QG
Novartis Investigative Site Recruiting
Preston, United Kingdom, PR2 9HT
Sponsors and Collaborators
Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03200717     History of Changes
Other Study ID Numbers: CPZP034A2410
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
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