- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01385228
Pazopanib, Docetaxel, Prednisone Prostate
Phase I Study of Docetaxel, Prednisone and Pazopanib in Men With Metastatic Castrate-Resistant Prostate Cancer (mCRPC) and Poor-Risk Factors
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This Phase I study will consist of a dose escalation portion which includes a dose escalation phase of 10 dose levels: (1a) docetaxel 60 mg/m2, pazopanib 400 mg daily, prednisone 5 mg BID; (2a) docetaxel 75 mg/m2, pazopanib 400 mg daily, prednisone 5 mg BID; and (3a) docetaxel 75 mg/m2, pazopanib 600 mg daily, prednisone 5 mg BID; (4a) docetaxel 75mg/m2, pazopanib 800 mg daily, (5a) docetaxel 75mg/m2, pazopanib 1000mg daily, prednisone 5 mg; (1b) docetaxel 60 mg/m2, pazopanib 400 mg daily x 17 days, prednisone 5 mg BID; (2b) docetaxel 75 mg/m2, pazopanib 400 mg daily x 17 days, prednisone 5 mg BID; and (3b) docetaxel 75 mg/m2, pazopanib 600 mg daily x 17 days, prednisone 5 mg BID; (4b) docetaxel 75mg/m2, pazopanib 800 mg daily x 17 days, (5b) docetaxel 75mg/m2, pazopanib 1000mg daily x 17 days, prednisone 5 mg. If the investigators see > 1 dose limiting toxicity (DLT) at Dose level 3 then the investigators would investigate docetaxel 75 mg/m2, pazopanib 600 mg daily, prednisone 5 mg BID (Dose level 3a). If < 1 DLT are seen at Dose level 3 and Pharmacokinetic (PK) analysis is complete and acceptable, then the investigators will proceed to dose level 4) docetaxel 75 mg/m2, pazopanib 1000 mg daily, prednisone 5 mg BID.
The investigators will dose escalate in a classic 3+3 design. The maximum tolerated dose (MTD) will be defined as the highest dose level that does not result in 2 or more dose limiting toxicities (DLTs). A dose expansion at the MTD of 10-15 patients (up to a total of 36 patients) will be accrued in order to further describe the safety profile.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Illinois
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Chicago, Illinois, Stati Uniti, 60637
- The University of Chicago
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North Carolina
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Durham, North Carolina, Stati Uniti, 27710
- Duke Cancer Institute
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Histologically confirmed carcinoma of the prostate. Histologic evidence may be confirmed through local or metastatic biopsy review. Non-adenocarcinomas are permitted.
- Radiographic evidence of metastatic disease; non-evaluable, bone only metastasis is permitted.
- Evidence of disease progression despite castrate levels of testosterone (<50 ng/dl).
- At the time of screening, at least 2 weeks since prior palliative radiation therapy and 4 weeks from major surgery, and resolution of all toxic effects of prior therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE); version 4.0 Grade < 1.
- Age >18 years
- Adequate laboratory parameters
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
- Life expectancy greater than 3 months
- Written, signed and dated Institutional Review Board (IRB) approved informed consent form.
Exclusion Criteria:
- History of or active central nervous system metastases
- The use of immunologic, biologic, or hormonal therapies within 2 weeks of study entry.
- Major surgery, open biopsy, traumatic injury within 4 weeks of the screening visit
- Subjects who have not recovered from prior biopsy, surgery, traumatic injury, and/or radiation therapy.
- Previous treatment with docetaxel, including in the neo-adjuvant or adjuvant setting
- Presence of non-healing wound or ulcer
- Grade 3 or greater hemorrhage within the past month.
- Uncontrolled hypertension
- American Heart Association Class 2-4 heart disease or any history of congestive heart failure with an ejection fraction <40%, recent cardiovascular event (within 12 months) including unstable angina, any exertional angina, myocardial infarction, exertional or rest claudication, or stroke/Cerebral Vascular Event/Transient Ischemic Attack. Patients with known moderate to severe documented carotid or peripheral vascular disease are excluded. Angioplasty or stenting of coronary or peripheral arteries are exclusionary if within the past 12 months.
- Anticoagulation with warfarin (therapeutic doses of warfarin for catheter patency are permitted up to 2 mg/day). Low molecular weight heparin is permitted.
- Diabetes mellitus with glycosylated hemoglobin A1c (HbgA1c) > 8% despite therapy
- Subjects with active autoimmune disorder(s) being treated with systemic immunosuppressive agents within 4 weeks prior to the screening visit.
- Active infection(s), active antimicrobial therapy or serious intercurrent illness.
- Does not agree to use medically acceptable contraceptive methods while on study and for 3 months after the last dose of pazopanib.
- Any other major medical or psychiatric illness that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in this study, including inability to absorb oral medications.
- Known hypersensitivity to any of the components in the docetaxel infusion or other medical reasons for not being able to receive adequate premedication (for example, antihistamine or anti-inflammatory agents).
- CalculatedQT (QTc) interval on baseline EKG > 500milliseconds
- History or presence of nephrotic syndrome
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Dose Level "Xa"
once daily pazopanib for Days 1-21 in combination with docetaxel given IV on Day 1 and prednisone daily.
Pegfilgrastim (Neulasta) every 21 days on Day 2, 3 or 4 of each cycle.
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Altri nomi:
Dose Level "Xa" - daily administration of pazopanib on days 1 through 21 starting at 400mg with a maximum dose of 1000mg.
Altri nomi:
Docetaxel given IV on Day 1 starting dose 60mg/m2 increase to 75mg/m2
Altri nomi:
Dose Level "Xb" - daily administration of pazopanib on days 3 through 19 starting at 400mg with a maximum dose of 1000mg.
Altri nomi:
5mg Prednisone given twice daily days 1-21.
|
Sperimentale: Dose Level "Xb"
once daily oral administration of pazopanib for Days 3-19 in combination with docetaxel given intravenous administration on Day 1 and prednisone daily.
Pegfilgrastim (Neulasta) every 21 days on Day 2, 3 or 4 of each cycle.
|
Altri nomi:
Dose Level "Xa" - daily administration of pazopanib on days 1 through 21 starting at 400mg with a maximum dose of 1000mg.
Altri nomi:
Docetaxel given IV on Day 1 starting dose 60mg/m2 increase to 75mg/m2
Altri nomi:
Dose Level "Xb" - daily administration of pazopanib on days 3 through 19 starting at 400mg with a maximum dose of 1000mg.
Altri nomi:
5mg Prednisone given twice daily days 1-21.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Number and Percent of Participants with Adverse Events as a Measure of Safety and Tolerability
Lasso di tempo: 15 months
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The primary objective for the phase I study is to assess the safety and tolerability of pazopanib, docetaxel, and prednisone given in combination in patients with metastatic castration resistant prostate cancer.
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15 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Establish the maximum tolerated dose
Lasso di tempo: 15 months
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Determine the dose levels of pazopanib and docetaxel that are the most tolerated.
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15 months
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Establish the optimal dosing schedule
Lasso di tempo: 15 months
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Establish the optimal dosing schedule for the combination of docetaxel, prednisone and pazopanib
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15 months
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Daniel J George, MD, Duke Cancer Institute
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Neoplasie
- Neoplasie urogenitali
- Neoplasie per sede
- Neoplasie genitali, maschio
- Malattie della prostata
- Neoplasie prostatiche
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti antinfiammatori
- Agenti antineoplastici
- Modulatori della tubulina
- Agenti antimitotici
- Modulatori della mitosi
- Glucocorticoidi
- Ormoni
- Ormoni, sostituti ormonali e antagonisti ormonali
- Agenti antineoplastici, ormonali
- Docetaxel
- Prednisone
Altri numeri di identificazione dello studio
- Pro00026577
- PZP113296 (Altro numero di sovvenzione/finanziamento: GSK)
- c09-039 (Altro identificatore: Prostate Cancer Clinical Trials Consortium)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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