- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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)
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Odotettu)
Yhteystiedot ja paikat
Opiskelupaikat
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Basildon, Yhdistynyt kuningaskunta
- Basildon and Thurrock University Hospitals NHS Foundation Trust
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Coventry, Yhdistynyt kuningaskunta
- University Hospitals Coventry & Warwickshire NHS Trust
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Glasgow, Yhdistynyt kuningaskunta
- The Beatson West of Scotland Cancer Centre
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London, Yhdistynyt kuningaskunta
- Barts and London Hospital NHS Trust
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London, Yhdistynyt kuningaskunta
- Oncology & Clinical Haematology Trials Unit, Royal Free Hospital
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London, Yhdistynyt kuningaskunta
- Oncology & Haematology Clinical Trials Unit, Guy's Hospital
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Oxford, Yhdistynyt kuningaskunta
- Department of Oncology Oxford Cancer Centre
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Southampton, Yhdistynyt kuningaskunta
- Southampton General Hospital
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Southend, Yhdistynyt kuningaskunta
- Southend University Hospital Trust
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Clinical benefit of 14 weeks of pre-operative pazopanib therapy, prior to nephrectomy using RECIST 1.1 criteria
Aikaikkuna: Interim analysis after 34 patients have 12 weeks of treatment
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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.
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Interim analysis after 34 patients have 12 weeks of treatment
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Surgical complications (blood loss, post operative complications, hospital stay)
Aikaikkuna: After the first 20 patients have had a nephrectomy
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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.
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After the first 20 patients have had a nephrectomy
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Overall Survival
Aikaikkuna: After three years of study
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Overall survival will be measured from start of treatment to time of death.
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After three years of study
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Progression free survival
Aikaikkuna: After all patients have progresssed
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Progression free survival will be measured from start of study treatment to time of disease progression.
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After all patients have progresssed
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Local response of primary tumour to pazopanib
Aikaikkuna: After 12 weeks of study drug
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After 12 weeks of study drug
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Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Odotettu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 2009-016675-29
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