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



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/13/2019
Start Date:November 14, 2017
End Date:August 27, 2021
Contact:Novartis Pharmaceuticals
Email:Novartis.email@novartis.com
Phone:1-888-669-6682

Use our guide to learn which trials are right for you!

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

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.


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
- 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
We found this trial at
3
sites
Caba, Buenos Aires
?
mi
from
Caba,
Click here to add this to my saved trials
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Saby George
Phone: 716-845-8452
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
Hackensack, New Jersey 07601
Principal Investigator: Robert Alter
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials