Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Safety Study of TAK-700 in Subjects With Prostate Cancer. (TAK-700)

4 marzo 2016 aggiornato da: Millennium Pharmaceuticals, Inc.

A Phase 1/2, Open-Label, Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of TAK-700 in Metastatic, Androgen-Independent Prostate Cancer Subjects

The purpose of this study is to determine the safety and tolerability of TAK-700 in patients with asymptomatic metastatic, androgen independent prostate cancer.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

123

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • California
      • Beverly Hills, California, Stati Uniti
        • USC Westside Prostate Cancer Center
      • Los Angeles, California, Stati Uniti
        • USC Norris Comprehensive Cancer Center
      • Los Angeles, California, Stati Uniti, 90048
        • University of Southern California
      • Los Angeles, California, Stati Uniti
        • The Angeles Clinic and Research Institute
    • Florida
      • Aventura, Florida, Stati Uniti
        • South Florida Medical Research
      • Fort Myers, Florida, Stati Uniti
        • Florida Cancer Specialists
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60637
        • University of Chicago
      • Chicago, Illinois, Stati Uniti, 60611
        • Northwestern University Medical Center
      • Chicago, Illinois, Stati Uniti
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, Stati Uniti
        • University of Chicago Pharmacy
      • Evanston, Illinois, Stati Uniti
        • Evanston Hospital
      • Evanston, Illinois, Stati Uniti
        • Northshore University Healthsystem
      • Evanston, Illinois, Stati Uniti
        • Kellogg Pharmacy - Evanston Hospital
      • Glenview, Illinois, Stati Uniti
        • Kellogg Cancer Care Center
    • New York
      • East Syracuse, New York, Stati Uniti
        • Hematology/Oncology Associates of Central New York
    • Ohio
      • Canton, Ohio, Stati Uniti
        • Gabrail Cancer Center
      • Cleveland, Ohio, Stati Uniti, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, Stati Uniti
        • Taussig Cancer Institute
    • Tennessee
      • Nashville, Tennessee, Stati Uniti
        • Tennessee Oncology

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Maschio

Descrizione

Inclusion Criteria:

  • Subject is male and at least 18 years of age.
  • Subject has histologically- or cytologically-confirmed prostate adenocarcinoma with metastatic, progressive disease while on androgen deprivation therapy.
  • Subject has radiograph-documented (computed tomography, magnetic resonance imaging or x-ray) metastatic disease.
  • Subject has undergone orchiectomy or is expected to continue receiving luteinizing hormone-releasing hormone analogue therapy, and has a testosterone level of <50 ng/dL at screening.
  • Subject has discontinued all antiandrogen therapy (within 30 days for flutamide and within 6 weeks for all others) prior to their first dose of study drug.
  • Subject has a prostate-specific antigen level ≥5 ng/mL.
  • Subject meets all screening laboratory values as specified in the protocol.
  • Subject has a screening ejection fraction that is above the lower limit of the institutional normal range.
  • Subject has ECOG performance status of 0 to 2.
  • Subject has normal or, in the opinion of the investigator, clinically insignificant, physical examination findings, ECG and chest x-ray results.
  • Subjects, even if surgically sterilized (ie, status postvasectomy), who: agree to practice effective barrier contraception during the entire study treatment period and for 4 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse.

Exclusion Criteria:

  • Subject has known hypersensitivity to TAK-700 or related compounds.
  • Subject has received prior therapy with aminoglutethimide or ketoconazole within 30 days prior to the first dose of study drug.
  • Subject has received prior chemotherapy for prostate cancer.
  • Subject has received any investigational compound within 30 days prior to first dose of study drug.
  • Subject has received prior herbal product known to decrease prostate-specific antigen levels (eg, Saw Palmetto, PC-SPES) within 30 days prior to the first dose of study drug.
  • Subject has received radiation therapy for prostate cancer within 30 days prior to first dose of study drug.
  • Chronic therapy with oral or other systemically administered corticosteroids, such as prednisone, within 30 days prior to Screening. Chronic therapy is defined as the use of corticosteroids for more than 7 days within a 30-day period.
  • Subject has current spinal cord compression, current bilateral hydronephrosis, or current bladder neck outlet obstruction.
  • Subject has a history of adrenal insufficiency.
  • Subject has a history of myocardial infarction, ischaemic symptomatic heart disease, cardiac arrhythmias or thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (e.g., pericardial effusion restrictive cardiomyopathy) within 12 months prior to first dose of study drug.
  • Subject has any symptoms which the investigator deems related to prostate cancer, i.e., bone pain, pelvic pain.
  • Subject has a history of congestive heart failure (New York Heart Association Class II or greater.
  • Subject has history of another malignancy other than basal cell carcinoma or state 1 squamous cell carcinoma of the skin, within the last 5 years.
  • Subject has uncontrolled hypertension.
  • Subject is known to have HIV infection, chronic Hepatitis B or C or any other serious medical condition or psychiatric illness that might affect life expectancy or make it difficult to successfully manage and follow the subject according to protocol.
  • Subject is unable to understand verbal or written English or any other language for which a certified translation of the institutional review board (IRB)-approved informed consent has been provided.
  • Subject is unwilling or unable to comply with the protocol or cooperate fully with the investigator and site personnel.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Arm 1 (TAK-700)
Droga: TAK-700

Phase 1 portion of study:

TAK-700 dose escalation. Tablets administered orally, twice daily until disease progression or occurrence of an unacceptable adverse event.

Phase 2 portion of study:

Patients will receive one of 4 treatments:

  • TAK-700 at 300 mg twice/day
  • TAK-700 at 400 mg and 5 mg prednisone twice/day
  • TAK-700 at 600 mg and 5 mg prednisone twice/day
  • TAK-700 at 600 mg once/day in the morning
Sperimentale: Arm 2 (TAK-700 at 400 mg & 5 mg prednisone)
Droga: TAK-700

Phase 1 portion of study:

TAK-700 dose escalation. Tablets administered orally, twice daily until disease progression or occurrence of an unacceptable adverse event.

Phase 2 portion of study:

Patients will receive one of 4 treatments:

  • TAK-700 at 300 mg twice/day
  • TAK-700 at 400 mg and 5 mg prednisone twice/day
  • TAK-700 at 600 mg and 5 mg prednisone twice/day
  • TAK-700 at 600 mg once/day in the morning
Sperimentale: Arm 3 (TAK-700 at 600 mg & 5 mg prednisone)
Droga: TAK-700

Phase 1 portion of study:

TAK-700 dose escalation. Tablets administered orally, twice daily until disease progression or occurrence of an unacceptable adverse event.

Phase 2 portion of study:

Patients will receive one of 4 treatments:

  • TAK-700 at 300 mg twice/day
  • TAK-700 at 400 mg and 5 mg prednisone twice/day
  • TAK-700 at 600 mg and 5 mg prednisone twice/day
  • TAK-700 at 600 mg once/day in the morning
Sperimentale: Arm 4 (TAK-700 at 600 mg)
Droga: TAK-700

Phase 1 portion of study:

TAK-700 dose escalation. Tablets administered orally, twice daily until disease progression or occurrence of an unacceptable adverse event.

Phase 2 portion of study:

Patients will receive one of 4 treatments:

  • TAK-700 at 300 mg twice/day
  • TAK-700 at 400 mg and 5 mg prednisone twice/day
  • TAK-700 at 600 mg and 5 mg prednisone twice/day
  • TAK-700 at 600 mg once/day in the morning

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Safety and tolerability of TAK-700 by evaluating adverse events, vital signs, physical examination findings, concomitant medications and laboratory tests.
Lasso di tempo: Cycle 1: Weeks 1, 2, 3 and 4, then every 4 weeks thereafter.
Cycle 1: Weeks 1, 2, 3 and 4, then every 4 weeks thereafter.

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Efficacy and pharmacokinetics (PSA response and/or objective disease response)
Lasso di tempo: Cycle 1: Weeks 1, 2, 3 and 4, then every 4 weeks thereafter.
Cycle 1: Weeks 1, 2, 3 and 4, then every 4 weeks thereafter.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Millennium Pharmaceuticals, Inc.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2008

Completamento primario (Effettivo)

1 gennaio 2013

Completamento dello studio (Effettivo)

1 febbraio 2013

Date di iscrizione allo studio

Primo inviato

4 dicembre 2007

Primo inviato che soddisfa i criteri di controllo qualità

4 dicembre 2007

Primo Inserito (Stima)

6 dicembre 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

4 aprile 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 marzo 2016

Ultimo verificato

1 marzo 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • TAK-700_201
  • TAK-700-201

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 .

Prove cliniche su TAK-700

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in United Arab Emirates

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi