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

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

ClinicalTrials.gov Identifier: NCT03200717

Novartis Reference Number: CPZP034A2410

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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 
Advanced Renal Cell Carcinoma
Metastatic Renal Cell Carcinoma
Phase 
Phase 2
Overall status 
Active, not recruiting
Enrollment count 
62 participants
Start date 
Nov 14, 2017
Completion date 
Jul 15, 2021
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

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.

Eligibility 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

Study Locations

United States
Roswell Park Cancer Institute
-
Buffalo, 14263
New York
United States
Argentina
Novartis Investigative Site
-
Caba, C1280AEB
Buenos Aires
Argentina
Austria
Novartis Investigative Site
-
Graz, 8036
-
Austria
Novartis Investigative Site
-
Salzburg, 5020
-
Austria
Novartis Investigative Site
-
Wien, A-1090
-
Austria
Canada
Novartis Investigative Site
-
Calgary, T2N 4N2
Alberta
Canada
Chile
Novartis Investigative Site
-
Temuco, 4810469
Araucania
Chile
Novartis Investigative Site
-
Santiago, 8420383
-
Chile
Czechia
Novartis Investigative Site
-
Brno, 656 53
Czech Republic
Czechia
Novartis Investigative Site
-
Olomouc, 775 20
CZE
Czechia
France
Novartis Investigative Site
-
Paris, 75015
-
France
Novartis Investigative Site
-
Strasbourg Cedex, F 67098
-
France
Novartis Investigative Site
-
Valenciennes, 59300
-
France
Germany
Novartis Investigative Site
-
Hannover, 30625
-
Germany
Novartis Investigative Site
-
Jena, 07740
-
Germany
Novartis Investigative Site
-
Tübingen, 72076
-
Germany
Hungary
Novartis Investigative Site
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Budapest, H 1122
-
Hungary
Spain
Novartis Investigative Site
-
Sevilla, 41013
Andalucia
Spain
Novartis Investigative Site
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Madrid, 28041
-
Spain
United Kingdom
Novartis Investigative Site
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London, NW3 2QG
-
United Kingdom
Novartis Investigative Site
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Manchester, M20 2BX
-
United Kingdom
Novartis Investigative Site
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Preston, PR2 9HT
-
United Kingdom

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