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

4 mars 2016 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

123

Phase

  • Phase 2
  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Homme

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Arm 1 (TAK-700)
Médicament: 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
Expérimental: Arm 2 (TAK-700 at 400 mg & 5 mg prednisone)
Médicament: 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
Expérimental: Arm 3 (TAK-700 at 600 mg & 5 mg prednisone)
Médicament: 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
Expérimental: Arm 4 (TAK-700 at 600 mg)
Médicament: 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Safety and tolerability of TAK-700 by evaluating adverse events, vital signs, physical examination findings, concomitant medications and laboratory tests.
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Délai
Efficacy and pharmacokinetics (PSA response and/or objective disease response)
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Millennium Pharmaceuticals, Inc.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2008

Achèvement primaire (Réel)

1 janvier 2013

Achèvement de l'étude (Réel)

1 février 2013

Dates d'inscription aux études

Première soumission

4 décembre 2007

Première soumission répondant aux critères de contrôle qualité

4 décembre 2007

Première publication (Estimation)

6 décembre 2007

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

4 avril 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 mars 2016

Dernière vérification

1 mars 2016

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • TAK-700_201
  • TAK-700-201

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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