A Study to evaluate the effectiveness and safety of Pazopanib in a real world scenario in patients with advanced stage of renal cell carcinoma.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/04/008347
• Date of registration: 13-04-2017
• Prospective Registration: Yes
• Primary sponsor: Novartis Healthcare Pvt Ltd
• Public title: A Study to evaluate the effectiveness and safety of Pazopanib in a real world scenario in patients with advanced stage of renal cell carcinoma.
• Scientific title: PAzopanib Real-world Assessment of Clinical effectiveness and safety in patients wHo have Undergone Treatment in different sEttings in advanced renal cell carcinoma; a prospective, non-interventional, observational study - PARACHUTE
• Date of first enrolment: 01-05-2017
• Target sample size: 250
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=17981
• Study type: Observational
• Study design: Single Arm Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: Phase 4

Countries of recruitment

Algeria, Egypt, Hong Kong, India, Lebanon, Malaysia, Singapore, Taiwan, Viet Nam

Contacts

• Name: Dr Manish Mistry
• Affiliation: Novartis India Limited

• Name: Dr Manish Mistry
• Affiliation: Novartis India Limited

Key inclusion & exclusion criteria

Inclusion criteria: 1-Documented diagnosis of advanced or metastatic RCC of any histology and treated

according to local practice and treated with pazopanib.

2-Clinical decision made to initiate new treatment with pazopanib or at least 15 days prior to

enrollment in the study.

3-Patients naïve to any prior anti-VEGF therapy (prior immunotherapy including cytokines

are allowed).

4-Patients who provide written informed consent according to local guidelines.

-Note: Patients will be allowed to participate in other interventional clinical studies

5-Before starting pazopanib therapy (except trials involving VEGF-TKI treatments

where the patient is randomized/included into the VEGF-TKI arm).

6-During the course of the study as long as the therapy is not a VEGF-TKI.


Exclusion criteria: 1-Prior treatment with VEGF-TKI before starting pazopanib therapy

2-Life expectancy < 12 weeks based on the Treating Physicianâ??s assessment.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- patients with advanced or metastatic RCC of any histology who are treated according to local practices and treated for the first time with pazopanib

Primary Outcome(s)

To describe the clinical effectiveness of pazopanib in the real-life setting in patients naïve

to VEGF-TKI therapy based on the proportion of patients remaining progression free at

12 months.Timepoint: To describe the clinical effectiveness of pazopanib in the real-life setting in patients naïve

to VEGF-TKI therapy based on the proportion of patients remaining progression free at

12 months.

Secondary Outcome(s)

To describe other clinical effectiveness factors for pazopanib.

Overall response rate (ORR) at 12 months.

Progression-free survival (PFS) at end of study (EOS). Overall survival (OS) at EOS.

Response (ORR and progression-free (PF) response) according to Memorial Sloan-

Kettering Cancer Center (MSKCC)/Heng criteria and age category.

To assess the safety and tolerability of pazopanib at 12 months.

Timepoint: Outcomes will be assessed at 3 months, 9 months, 12 months and at the end of the study around 30 months

Secondary ID(s)

NIL

Source(s) of Monetary Support

Novartis Healthcare Private Limited, Sandoz House, Shivsagar Estate, Worli, Mumbai - 400012

Ethics review

Status: Approved
Approval date: 18/03/2017
Contact:

Institutional Ethics Committee

Status: Approved
Approval date: 04/04/2017
Contact:

Health Care Global Enterprises Limited Institutional Ethics Committee (HCG-IEC)

Status: Approved
Approval date: 23/05/2017
Contact:

Ethics Committee, Unique Hospital Multispeciality and Research Institute

Status: Approved
Approval date: 15/09/2017
Contact:

Ethics Committee-V S Hospital

Status: Approved
Approval date: 16/09/2017
Contact:

Institutional Ethics Committee, Apollo Gleneagles Hospitals

Status: Approved
Approval date: 08/01/2018
Contact:

institutional review board Tata Medical Centre

Status: Approved
Approval date: 19/03/2018
Contact:

Institutional Ethics Committee Sanjay Gandhi Postgraduate Institute of Medical Sciences