Condition category
Cancer
Date applied
29/03/2012
Date assigned
29/03/2012
Last edited
09/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Steve Johnson

ORCID ID

Contact details

PaZ02 trials office
Cancer Research UK Clinical Trials Unit (CRCTU)
School of Cancer Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
-
info@isrctn.com

Additional identifiers

EudraCT number

2011-001211-31

ClinicalTrials.gov number

Protocol/serial number

11827

Study information

Scientific title

A study of PaZopanib efficacy and safety in patients with advanced clear-cell renal cell carcinoma and ECOG Performance Status 2 (PaZ02): A non-randomised phase II trial

Acronym

PaZ02

Study hypothesis

New treatments which are active and well tolerated are needed for patients with advanced renal cancer who suffer from symptoms that are bad enough to affect their quality of life and ability to carry on with their daily routine. These patients are classed as ‘Performance Status 2’. The objective of this study is to see if a new drug called pazopanib can prevent the renal cancer from growing and see if it is well tolerated by patients with advanced renal cancer who are classed as ‘Performance Status 2’.

Pazopanib works by disrupting the capillaries and blood vessels which supply the tumour tissue with blood and nutrients. In previous clinical trials pazopanib has demonstrated a significant effectiveness in advanced renal cell cancer patients who are less affected by their symptoms and is currently used for their treatment. It has not yet been tested in patients with ‘Performance Status 2’.

More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=11827

Ethics approval

East Midlands - Nottingham 2 Committee First MREC approval date 24th February 2012, ref: 11/EM/0450

Study design

Non-randomised; Interventional; Design type: Diagnosis, Prevention, Process of Care, Screening, Treatment

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: National Cancer Research Network; Subtopic: Renal Cancer; Disease: Kidney

Intervention

Pazopanib, Patients will receive pazopanib 800 mg once daily (OD) orally continuous dosing.

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

Efficacy and tolerability
1. Efficacy: proportion of patients who are progression free and alive at 6 months
2. Tolerability: Ratio of patients free of grade 3, grade 4 adverse events which are related to the study medication and deemed to be clinically relevant

Secondary outcome measures

1. Overall survival
2. Progression Free Survival (PFS)
3. Response and clinical benefit rates
4. Duration of response
5. Treatment safety dose

Overall trial start date

01/04/2011

Overall trial end date

01/04/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Written informed consent
2. Histologically confirmed diagnosis of renal cell carcinoma with clear cell component
3. Locally advanced (defined as not amenable of curative surgery) or metastatic disease
4. Measurable disease as per Response Evaluation Criteria In Solid Tumors (RECIST) Criteria 1.1
5. Performance Status 2 assessed using the ECOG scale
6. No prior systemic therapy
7. Female patients of childbearing potential will be eligible if they agree to adequate contraception. Pregnancy test must be negative 1 week before first drug dose
8. Adequate organ function as defined by the following criteria:
8.1. Total serum bilirubin ≤1.5 x upper limit normal (ULN). Patients with Gilbert’s disease are eligible if the total bilirubin is <3.0 x ULN and direct bilirubin is ≤ 35%.
8.2. Serum transaminases (AST and ALT) <2.5 x ULN, unless liver metastases are documented in which case AST and ALT must be ≤ 5 x ULN
8.3. Calculated creatinine clearance ≥ 30mL/min (Cockroft Gault method)
8.4. Urine Protein to Creatinine Ratio (UPC) < 1. If UPC ≥ 1 then a 24 hour urine protein must be assessed. Only patients with 24 hour urine protein < 1g will be eligible
8.5. Total serum calcium concentration < 2.9 mmol/l
8.6. Absolute neutrophil count (ANC) ≥ 1500/mm3
8.7. Haemoglobin ≥ 9g/dl
8.9. Platelets ≥ 100,000/mm3
8.10. INR (International Normalised ratio) ≤ 1.2 x ULN. Subjects receiving anticoagulant therapy are eligible if their INR is stable and within the recommended range
9. Age ≥18
10. Life expectancy ≥ 12 weeks
11. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 75; UK Sample Size: 75

Participant exclusion criteria

1. Pregnant or lactating female patients. Patients who agree to discontinue nursing 14 days prior to commencing treatment and do not nurse throughout all the treatment period are eligible
2. Previous systemic treatment for renal cell carcinoma (RCC) (licensed or investigational) including adjuvant or neoadjuvant therapy
3. Major surgery or trauma < 4 weeks or radiotherapy and/or presence of any nonhealing wound, fracture, or ulcer. Radiotherapy < 2 weeks prior to starting treatment
4. History or clinical evidence of brain metastases or active seizure disorders
5. Previous malignancies within the last 5 years, with the exception of successfully treated superficial or in situ carcinomas and of invasive tumours treated with curative intent and in remission for at least 5 years
6. Current use of drugs which are known strong CYP4A inhibitors (7.10)
7. Use of any prohibited medications within 14 days of the first dose of study medication (
8. Uncontrolled hypertension defined as systolic blood pressure ≥ 150 mm Hg or diastolic blood pressure ≥ 95 mm Hg. Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry
9. Presence of uncontrolled infection
10. Prolongation of the QT interval (QTc) > 480 msecs
11. History of malabsorption, major gastrointestinal tract resection or other pathology likely to affect study drug absorption
12. History of any one or more of the following cardiovascular conditions within the past 6 months:
12.1. Cardiac angioplasty or stenting
12.2. Myocardial infarction
12.3. Unstable angina
12.4. Coronary artery bypass graft surgery
12.5. Symptomatic peripheral vascular disease
12.6. Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) Functional Classification
13. History of cerebrovascular accident (CVA) including transient ischemic attack (TIA) within the past 12 months
14. History of pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Patients with recent DVT who have been treated with therapeutic anticoagulating agents for at least 6 weeks are eligible
15. Evidence of active bleeding or bleeding diathesis
16. Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
17. Any serious and/or unstable preexisting medical, psychiatric, or other conditions that could interfere with subject’s safety, obtaining informed consent or compliance to the study 18)Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drug chemically related to pazopanib

Recruitment start date

01/04/2011

Recruitment end date

01/04/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

PaZ02 trials office
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Institute of Research and Development
Institute of Research and Development
Birmingham Research Park Vincent Drive
Birmingham
B15 2SQ
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

GlaxoSmithKline Research and Development (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

09/05/2016: No publications found, study status unverified.