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HYPAZ: An Open-label Investigation Into Hypertension Induced by Pazopanib Therapy

This study is currently Recruiting

June 2011 By Cambridge University Hospitals NHS Foundation Trust

First Recieved on June 30, 2011

Last Updated on July 11, 2011

Sponsor: Cambridge University Hospitals NHS Foundation Trust
Collaborators: University of Cambridge
Information provided by: Cambridge University Hospitals NHS Foundation Trust
Identifier: NCT01392352

Purpose

Pazopanib is a new cancer drug that works by limiting the growth of new blood vessels in tumours. About half of patients who take pazopanib develop high blood pressure (hypertension). This side effect can make patients have to reduce or stop their cancer treatment, and can cause other health problems. The aim of this study is to find out exactly how the drug causes high blood pressure.

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: 1. Patients must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up. 2. Patients with the following tumour types where VEGF inhibition would be appropriate therapy: a Renal cell carcinoma (1L, 2L, excluding previous Tyrosine Kinase Inhibitors Rx) b Ovarian carcinoma with a rising CA-125, 2nd or subsequent lines c Ovarian carcinoma with residual disease after chemotherapy in the absence of rising CA-125, 2nd or subsequent lines d Cervical cancer, metastatic or recurrent, and progressing after conventional chemotherapy e Glioblastoma, progressing after conventional chemotherapy f Advanced or metastatic soft tissue sarcoma, residual disease post chemotherapy in the absence of progression, 2nd or subsequent lines g Non-small cell lung cancer, 1st or subsequent lines h ErbB2 positive, advanced or metastatic breast cancer, 2nd or subsequent lines i Gemcitabine-refractory pancreatic cancer, 2nd or subsequent lines j Non-cutaneous (ocular or mucosal) melanoma and cutaneous melanoma any line k GI tract 2nd line residual disease or subsequent lines l Small Cell Lung cancer 3rd line m Other solid tumours in which anti-VEGF therapy is judged by the CI to be of possible clinical benefit 3. Measurable disease as per RECIST 1.1. 4. ECOG performance status 0 or 1. 5. Age ?18 years. 6. Adequate organ system function 7. Female participant, or female partner of male participant, are of non-childbearing potential or agree to protocol-specified contraceptive measures Exclusion Criteria: 1. Known hypertension (blood pressure >140/90 mmHg) at baseline 2. On anti-hypertensive therapy 3. History of any one or more of the following cardiovascular conditions: a Cardiac angioplasty or stenting b Myocardial infarction c Unstable angina d Coronary artery bypass graft surgery e Peripheral vascular disease or Raynaud's phenomenon f Cerebrovascular accident (CVA) including transient ischaemic attack (TIA), g Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) 4. Hypersensitivity to agents used in forearm blood flow studies 5. Difficult upper limb arterial access 6. Diabetes, on oral therapy/insulin 7. Anticoagulant therapy (warfarin). 8. Pregnant or lactating female 9. Central nervous system (CNS) metastases. 10. Gastrointestinal abnormalities that may increase the risk for GI bleeding 11. Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product 12. Presence of uncontrolled infection 13. Corrected QT interval (QTc) > 480 msecs using Bazett's formula 14. History of pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months 15. Prior major surgery or trauma within 28 days prior to first dose and/or presence of any non-healing wound, fracture, or ulcer. 16. Evidence of active bleeding or bleeding diathesis 17. Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels 18. Significant haemoptysis within prior 6 weeks 19. Pre-existing medical, psychiatric, or other condition that could interfere with patient's safety, provision of informed consent, or compliance to study procedures. 20. Unable or unwilling to discontinue use of prohibited medications for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib and for the duration of the study. 21. Treatment with any of the following anti-cancer therapies: a radiation therapy, surgery or tumour embolization within 14 days prior to the first dose of pazopanib OR b chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib c pazopanib or other antiangiogenic treatment (e.g. bevacizumab) 22. Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia. 23. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib

Investigators

Locations

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, Cambridgeshire CB2 0QQ United Kingdom

Conditions related to this trial:

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