- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01512186
A Phase II Study Investigating Upfront Pazopanib In Metastatic Renal Cancer Renal Cancer (Panther) (Panther)
A Phase II Study Investigating Upfront Pazopanib In Metastatic Clear Cell Renal Cancer (Panther)
Studie Overzicht
Toestand
Gedetailleerde beschrijving
This is a Phase II, open label study evaluating pre-operative pazopanib treatment in previously untreated patients with metastatic clear cell renal cancer. This study follows a Simon 2 stage design
Patients will take pazopanib for 14 weeks followed by a nephrectomy. The drug will continue after nephrectomy until disease progression is documented. Patients will come off study once disease progression occurs, where they will then be followed for survival. Subsequent treatment at the discretion of the treating physician will be documented.
After surgery, all patients will be radiologically evaluated 8 weekly until progression. Standard radical nephrectomy with lymph node dissection will be performed on those patients who are deemed operable. The surgery can be laparoscopic or open. Those not deemed suitable for nephrectomy after 14 weeks of treatment will be offered a repeat biopsy.
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
-
-
-
Basildon, Verenigd Koninkrijk
- Basildon and Thurrock University Hospitals NHS Foundation Trust
-
Coventry, Verenigd Koninkrijk
- University Hospitals Coventry & Warwickshire NHS Trust
-
Glasgow, Verenigd Koninkrijk
- The Beatson West of Scotland Cancer Centre
-
London, Verenigd Koninkrijk
- Barts and London Hospital NHS Trust
-
London, Verenigd Koninkrijk
- Oncology & Clinical Haematology Trials Unit, Royal Free Hospital
-
London, Verenigd Koninkrijk
- Oncology & Haematology Clinical Trials Unit, Guy's Hospital
-
Oxford, Verenigd Koninkrijk
- Department of Oncology Oxford Cancer Centre
-
Southampton, Verenigd Koninkrijk
- Southampton General Hospital
-
Southend, Verenigd Koninkrijk
- Southend University Hospital Trust
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
Histopathologically confirmed clear cell carcinoma with measurable metastases on CT/MRI imaging (by RECIST v1.1). Only a component of clear cell is required.
- No prior systemic treatment or nephrectomy for RCC. Palliative radiotherapy is acceptable to non target lesions.
Adequate organ function as defined by the following criteria:
i. Total serum bilirubin ≤1.5 x uln (patients with gilbert's disease exempt) ii. Serum transaminases (ALT) <3 x uln iii. Calculated creatinine clearance >30ml/min iv. Absolute neutrophil count (ANC) ≥1000/mm3 without growth factor support v. Platelets ≥ 75,000/mm3
- Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrolment.
- Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures
- ECOG performance status of 0, 1 or 2.
- 18 years or above (no upper age limit) Male or female
Exclusion Criteria:
Congestive heart failure (class III or IV NYHA), myocardial infarction or coronary artery bypass graft/ stenting or stroke in the previous six months, ongoing severe or unstable arrhythmia requiring medication.
- Previous treatment for renal cancer
- Pregnancy or breastfeeding. Female patients must be surgically sterile, be postmenopausal, or must agree to use adequate contraception during the period of therapy.
- Male patients must be surgically sterile or agree to use adequate contraception during the period of therapy.
- Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would in the judgement of the investigator, impart excess risk associated with study participation or study drug administration, or which, in the judgement of the investigator, would make the patient inappropriate for entry into this study
- Prolonged QT interval >480msecs or a history of prolonged QT interval >480msecs
- Ongoing major gastrointestinal disease including ulcerative colitis, bleeding peptic ulcer disease or inflammatory bowel disease.
- Bleeding diathesis
- Current uncontrolled hypertension
- Another malignancy requiring treatment within the last 5 years. Local prostate cancer not requiring hormone therapy or an asymptomatic raised PSA is acceptable.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Clinical benefit of 14 weeks of pre-operative pazopanib therapy, prior to nephrectomy using RECIST 1.1 criteria
Tijdsspanne: Interim analysis after 34 patients have 12 weeks of treatment
|
12 week CT scan will be compared to the baseline CT scan using RESIST criteria 1.1 to assess whether the patients have benefited from the upfront pazopanib treatment.
|
Interim analysis after 34 patients have 12 weeks of treatment
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Surgical complications (blood loss, post operative complications, hospital stay)
Tijdsspanne: After the first 20 patients have had a nephrectomy
|
Following surgery information regarding the quantity of blood loss, time the surgery took, length of hospital stay and whether there were any surgical complications will be recorded.
|
After the first 20 patients have had a nephrectomy
|
Overall Survival
Tijdsspanne: After three years of study
|
Overall survival will be measured from start of treatment to time of death.
|
After three years of study
|
Progression free survival
Tijdsspanne: After all patients have progresssed
|
Progression free survival will be measured from start of study treatment to time of disease progression.
|
After all patients have progresssed
|
Local response of primary tumour to pazopanib
Tijdsspanne: After 12 weeks of study drug
|
After 12 weeks of study drug
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2009-016675-29
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Gemetastaseerde nierkanker met heldere cellen
-
Peking University First HospitalWervingNiercelcarcinoom, Clear Cell, SomatischChina
-
Radboud University Medical CenterDutch Cancer SocietyVoltooidNierneoplasmata | Clear-cell gemetastaseerd niercelcarcinoomNederland
-
Bristol-Myers SquibbOno Pharmaceutical Co. LtdVoltooidNiercelcarcinoom | Clear-cell gemetastaseerd niercelcarcinoomVerenigde Staten, Canada
-
PfizerVoltooidCarcinoom, niercel | Clear-cell gemetastaseerd niercelcarcinoomKalkoen
-
AIO-Studien-gGmbHBristol-Myers SquibbVoltooidCarcinoom, niercel | Clear-cell gemetastaseerd niercelcarcinoomSpanje, Frankrijk, Italië, Duitsland, Verenigd Koninkrijk, België, Tsjechië, Oostenrijk
-
Cliniques universitaires Saint-Luc- Université...BeëindigdClear-cell gemetastaseerd niercelcarcinoomBelgië
-
Fondazione IRCCS Istituto Nazionale dei Tumori,...BeëindigdClear-cell gemetastaseerd niercelcarcinoomItalië
-
Celldex TherapeuticsBeëindigdNeoplasmata | Neoplasmata per histologisch type | Nierneoplasmata | Carcinoom, niercel | Urologische neoplasmata | Urogenitale neoplasmata | Nier Ziekten | Urologische ziekten | Clear-cell gemetastaseerd niercelcarcinoomVerenigde Staten
-
Millennium Pharmaceuticals, Inc.VoltooidClear-cell gemetastaseerd niercelcarcinoomSpanje, Tsjechië, Verenigde Staten, Canada, Italië, Verenigd Koninkrijk, Frankrijk, Polen
-
Association Pour La Recherche des Thérapeutiques...VoltooidClear-cell gemetastaseerd niercelcarcinoom | Niercarcinoom met heldere cellenFrankrijk