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
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
2 other identifiers
interventional
62
11 countries
22
Brief Summary
The main purpose of this study was to assess the progression-free survival (PFS) based on local investigator assessment of pazopanib in participants with advanced and/or metastatic renal cell carcinoma (mRCC) following prior treatment with immune checkpoint inhibitors (ICI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2017
Typical duration for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2017
CompletedFirst Posted
Study publicly available on registry
June 27, 2017
CompletedStudy Start
First participant enrolled
November 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2021
CompletedResults Posted
Study results publicly available
March 21, 2023
CompletedAugust 21, 2023
August 1, 2023
3.7 years
June 20, 2017
July 15, 2022
August 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
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 was assessed via local review according to RECIST 1.1. PFS was censored at the date of the last adequate tumor assessment if no PFS event (disease progression or death due to any cause) was observed prior to the analysis cut-off date. The PFS distribution was estimated using the Kaplan-Meier method.
Date of first treatment to date of progression or death up to approximately 38 months
Secondary Outcomes (6)
Overall Response Rate (ORR) Based on Local Investigator Assessment According to RECIST v1.1
Up to approximately 38 months
Clinical Benefit Rate (CBR) Based on Local Investigator Assessment According to RECIST v1.1.
Up to approximately 38 months
Overall Survival (OS)
From date of first treatment to date of death, up to approximately 44 months
Duration of Response (DOR) Based on Local Investigators Assessment According to RECIST v1.1
From the date of first documented response (confirmed CR or PR) to the date of tumor progression, up to approximately 36 months
Change From Baseline in Functional Assessment of Cancer Therapy- Kidney Symptom (FKSI-DRS) Score
Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 9, 11, 13, 16 and every 3rd cycle thereafter until end of treatment, and end of treatment, assessed up to approximately 38 months. Cycle=28 days
- +1 more secondary outcomes
Study Arms (2)
Pazopanib- 2nd line treatment
EXPERIMENTALParticipants received pazopanib as 2nd line treatment
Pazopanib- 3rd line treatment
EXPERIMENTALParticipants received pazopanib as 3rd line treatment
Interventions
Participants received 800mg of pazopanib once daily orally. Pazopanib was supplied as aqueous film-coated tablets containing 200 mg or 400 mg.
Eligibility Criteria
You may qualify if:
- Histologically confirmed locally recurrent or metastatic predominantly clear cell renal cell carcinoma.
- Measurable disease based on RECIST 1.1 criteria
- 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 were 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 received 4 or more weeks before start of study treatment
- Karnofsky performance status ≥70%.
- Potassium, sodium, calcium and magnesium within normal limits of the central laboratory
You may not qualify if:
- Renal cell carcinoma without any clear (conventional) cell component
- History or evidence of central nervous system (CNS) metastases (patients with pretreated metastases were 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 were considered 1 line of therapy)
- Not recovered from toxicity from prior immune checkpoint inhibitor therapy. Recovery was 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 could not be discontinued or replaced by safe alternative medication at least 5 half-lives of the concomitant medication or 7 days, whichever was 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Novartis Investigative Site
Caba, Buenos Aires, C1280AEB, Argentina
Novartis Investigative Site
Graz, 8036, Austria
Novartis Investigative Site
Salzburg, 5020, Austria
Novartis Investigative Site
Vienna, A-1090, Austria
Novartis Investigative Site
Calgary, Alberta, T2N 4N2, Canada
Novartis Investigative Site
Temuco, Región de la Araucanía, 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
Strasbourg, F 67098, France
Novartis Investigative Site
Valenciennes, 59300, France
Novartis Investigative Site
Hanover, 30625, Germany
Novartis Investigative Site
Jena, 07740, Germany
Novartis Investigative Site
Tübingen, 72076, Germany
Novartis Investigative Site
Budapest, H 1122, Hungary
Novartis Investigative Site
Seville, Andalusia, 41013, Spain
Novartis Investigative Site
Madrid, 28041, 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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study director
- Organization
- Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2017
First Posted
June 27, 2017
Study Start
November 14, 2017
Primary Completion
August 10, 2021
Study Completion
August 10, 2021
Last Updated
August 21, 2023
Results First Posted
March 21, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.