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FASE II ONDERZOEK NAAR DE EFFECTIVITEIT VAN PAZOPANIB BIJ PATI╦NTEN MET BAARMOEDERKANKER.


- candidate number10522
- NTR NumberNTR3139
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-nov-2011
- Secondary IDs2011-000287-99 METC AMC
- Public TitleFASE II ONDERZOEK NAAR DE EFFECTIVITEIT VAN PAZOPANIB BIJ PATI╦NTEN MET BAARMOEDERKANKER.
- Scientific TitleAn open-label multicenter phase II study of pazopanib in metastatic and locally advanced hormone-resistant endometrial cancer.
- ACRONYMPAZEC
- hypothesisOral pazopanib once daily is safe and effective in advanced endometrial cancer for which no other therapies are available.
- Healt Condition(s) or Problem(s) studiedEndometrial carcinoma
- Inclusion criteria1. Written informed consent;
2. Age ≥ 18 years;
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
4. Histologically or cytologically confirmed diagnosis of endometrial cancer;
5. Metastatic disease or locally advanced tumor not amenable to local therapy;
6. Documented progressive disease before enrolment;
7. Measurable lesions outside irradiated field or progressive measurable lesions in irradiated area;
8. Not eligible for hormonal therapy (because of negative hormone receptor/poor differentiation, or after failure of hormonal therapy);
9. Previous failure of chemotherapy, or refusal to undergo chemotherapy or chemo-naive patients not suitable for chemotherapy;
10. Adequate organ system function.
- Exclusion criteria1. Prior malignancy. Note: Subjects who have had another malignancy and have been disease-free for 5 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible;
2. History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, with no radiological signs of progression and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug;
3. Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding or may affect absorption of investigational product;
4. Presence of uncontrolled infection;
5. Corrected QT interval (QTc) > 480 msecs using Bazettĺs formula;
6. History of major cardiovascular conditions within the past 6 months or poorly controlled hypertension, history of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible;
7. Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major);
8. Evidence of active bleeding or bleeding diathesis;
9. Treatment with any of the following anti-cancer therapies: radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-nov-2011
- planned closingdate1-nov-2013
- Target number of participants55
- InterventionsPazopanib 800 MG PO continuously until progression, unacceptable toxicity or patient refusal.
- Primary outcomePercentage of patients free of progression at 3 months.
- Secondary outcome1. Response rate;
2. Progression free survival;
3. Overall survival;
4. Tolerability/toxicity.
- Timepoints3 months for primary endpoint.
Until progression or death for other outcomes.
- Trial web sitewww.dgog.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. A.M. Westermann
- CONTACT for SCIENTIFIC QUERIESDr. A.M. Westermann
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
GlaxoSmithKline
- PublicationsN/A
- Brief summaryThis is a multicenter, open-label, non-randomized phase II study based on the optimal two-step Simon design. All eligible patients will be treated with pazopanib 800 mg PO daily until progression, unacceptable toxicity or patient refusal. After the end of study treatment, patients will be assessed for vital status every 3 months until death.
- Main changes (audit trail)
- RECORD15-nov-2011 - 21-nov-2011


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