- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00526149
BI 2536 in Treating Patients With Recurrent or Metastatic Solid Tumors
Multicenter Parallel Phase II Trial of BI 2536 Administered as One Hour IV Infusion Every 3 Weeks in Defined Cohorts of Patients With Various Solid Tumors. A New Drug Screening Program of the EORTC Network of Core Institutions (NOCI)
RATIONALE: BI 2536 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects and how well BI 2536 works in treating patients with recurrent or metastatic solid tumors.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
OBJECTIVES:
- Investigate if BI 2536 demonstrates antitumor activity in the selected tumor types.
- Further document its safety profile in the treated patient population.
- Describe the plasma concentration time-course following administration of a single administration of BI 2536 in patients with different tumor types using an appropriate population pharmacokinetic model.
OUTLINE: This is a multicenter study.
Patients receive BI 2536 IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Blood is collected periodically during study. Plasma samples are analyzed for pharmacokinetic studies by HPLC and tandem mass spectrometry.
After completion of study treatment, patients are followed every 3 months.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Leuven, Belgique, B-3000
- U.Z. Gasthuisberg
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
DISEASE CHARACTERISTICS:
Tumor-specific criteria:
Head and neck cancer:
- Histologically or cytologically proven squamous cell carcinoma of the head and neck (excluding nasopharyngeal primaries)
- Patients presenting with new non-irradiated lesions in pre-irradiated field as target lesions are eligible
- Recurrent or metastatic disease, no longer suitable for local therapy
- Prior use of chemotherapy/chemoradiotherapy/EGFR inhibitors for the treatment of the primary disease/nonmetastatic disease is allowed
No prior chemotherapy for recurrent or metastatic disease
- Prior treatment with EGFR inhibitor for metastatic advanced disease is allowed
Breast cancer
- Histologically proven recurrent or metastatic adenocarcinoma of the breast that failed prior taxane and anthracycline therapy
- Patient must have had a minimum of one line and a maximum of 2 lines of chemotherapy treatment given either as adjuvant treatment or for recurrence/metastatic disease
- Patients who do not qualify for Her-2-based therapy allowed
- Hormone receptor status not specified
Ovarian cancer
- Histologically proven ovarian epithelial cancer
- Metastatic or inoperable locally advanced disease
- Patients either progressing under or relapsing within 6 months of completion of any line of platinum and taxane-based therapeutic regimen for advanced disease
Soft tissue sarcoma
Histologically proven advanced and/or metastatic malignant soft tissue sarcoma of high or intermediate grade and one of the following histologies defined by the WHO classification 2002:
- Leiomyosarcoma, adipocytic sarcoma, synovial sarcoma, and others
- Fibroblastic (adult fibrosarcoma, myxofibrosarcoma, sclerosing epithelioid fibrosarcoma)
- So-called fibrohistiocytic (pleomorphic malignant fibrous histiocytoma [MFH], giant cell "MFH", inflammatory "MFH")
- Malignant glomus tumors
- Skeletal muscles (rhabdomyosarcoma, alveolar or pleomorphic) excluding embryonic rhabdomyosarcoma
- Vascular (epithelioid hemangioendothelioma, angiosarcoma)
- Uncertain differentiation (synovial, epithelioid, alveolar soft part, clear cell, desmoplastic small round cell, extra-renal rhabdoid, malignant mesenchymoma, perivascular epithelioid cell tumour [PEComa], intimal sarcoma) excluding chondrosarcoma, Ewing tumors/primitive neuroectodermal tumor (PNET)
- Malignant peripheral nerve sheath tumors
- Malignant solitary fibrous tumors
- Undifferentiated soft tissue sarcomas not otherwise specified
- Other types of sarcoma (not listed as not eligible), if approved by the Study Coordinator (written or e-mail approval needed prior to registration)
Excluded are any of the following:
- Embryonic rhabdomyosarcoma
- Chondrosarcoma
- Osteosarcoma
- Ewing tumors/primitive neuroectodermal tumors
- Gastrointestinal stromal tumor
- Dermatofibrosarcoma protuberans
- Inflammatory myofibroblastic sarcoma
- Neuroblastoma
- Malignant mesothelioma
- Mixed mesodermal tumors of the uterus
- Patients must have received no more than one combination or two single agents of chemotherapy regimen for advanced disease and treatment must have included an anthracycline if not medically contraindicated
Melanoma
- Histologically proven metastatic malignant melanoma
- Ocular melanomas are excluded
Patients must either not have received any prior chemotherapy for recurrent /metastatic disease or have received one line of chemotherapy pending LDH ≤ 2 times upper limit of normal (ULN)
- One prior line of immunotherapy is allowed
General criteria:
- Measurable disease, defined as unidimensionally measurable based on RECIST with a target lesion of at least 20 mm or 10 mm measured by spiral CT scan
- Documented progressive disease proven by imaging prior to study entry (i.e., progression should be documented by 2 imaging scans performed within the past 6 months prior to registration showing progression according to RECIST)
- No clinical evidence of brain metastases
PATIENT CHARACTERISTICS:
- Male or female
- Menopausal status not specified
- ECOG performance status 0-2
- ANC ≥ 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Hemoglobin ≥ 9 mg/dL
- Serum creatinine ≤ to 175 μmol/L
- Bilirubin ≤ 1.5 times ULN
- AST/ALT ≤ 2.5 times ULN (5 times ULN with liver metastases)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 12 months after completion of study treatment
- Absence of any psychological, familial, sociological, or geographical factors that would potentially hamper compliance with the study protocol and follow-up schedule
- No other previous or active malignancy for at least 5 years with the exception of cone-biopsied carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma
No concomitant intercurrent illnesses including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situation that would limit compliance with trial requirement or that are considered relevant for the evaluation of the efficacy or safety of the trial drug
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 4 weeks since administration of any prior systemic treatment for the current malignancy including treatment with chemotherapy, radiotherapy, immunotherapy, hormonal therapy, and treatment with monoclonal antibodies, or small molecule tyrosine kinase inhibitors and others
- No persistence of toxicities from prior anticancer therapy deemed clinically relevant
- No treatment with any other investigational drug within the past four weeks or within less than four half-life times of the investigational drug before treatment with the trial drug (whatever is the longest period)
- No major surgery within 4 weeks prior to the first treatment with the trial drug
- Concurrent treatment with corticosteroids, including prednisone and bisphosphonates, is allowed as long as the treatment started before entry into the study and as long as the dose is stable for two weeks prior to enrollment in the present trial
Palliative radiotherapy may be given during the study for bone pain or for other reasons not due to progressive disease (e.g., bronchial obstruction, ulcerating skin lesions)
- The irradiated area should be limited and should not involve more than 10% of the bone marrow
- The irradiated area cannot be used for tumor response assessment
- No other concurrent investigational drugs
- No concurrent anti-tumor therapies such as chemotherapy, hormone therapy, gene therapy, tyrosine kinase inhibitors, or therapy with monoclonal antibodies or immunotherapy
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Masquage: Aucun (étiquette ouverte)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
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Confirmed objective response rate (complete and partial responses) as defined by RECIST
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Mesures de résultats secondaires
Mesure des résultats |
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La survie globale
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Durée de la réponse
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Clinical benefit as assessed by RECIST
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Survie globale sans progression
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Safety as assessed by CTCAE version 3.0
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Collaborateurs et enquêteurs
Les enquêteurs
- Chaise d'étude: Patrick Schoffski, MD, MPH, University Hospital, Gasthuisberg
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
- cancer du sein de stade IV
- cancer du sein récurrent
- cancer épidermoïde métastatique récurrent du cou avec primitif occulte
- cancer épidermoïde du cou métastatique avec carcinome épidermoïde primitif occulte
- carcinome épidermoïde récurrent de la lèvre et de la cavité buccale
- carcinome épidermoïde récurrent de l'oropharynx
- carcinome épidermoïde récurrent de l'hypopharynx
- carcinome épidermoïde récurrent du larynx
- carcinome épidermoïde récurrent du sinus paranasal et de la cavité nasale
- cancer de l'épithélium ovarien de stade III
- cancer de l'épithélium ovarien de stade IV
- cancer épithélial ovarien récurrent
- mélanome récurrent
- mélanome de stade IV
- angiosarcome adulte
- fibrosarcome adulte
- léiomyosarcome adulte
- liposarcome adulte
- neurofibrosarcome adulte
- sarcome synovial de l'adulte
- sarcome des tissus mous de l'adulte de stade IV
- sarcome récurrent des tissus mous de l'adulte
- sarcome alvéolaire des parties molles de l'adulte
- sarcome épithélioïde adulte
- histiocytome fibreux malin de l'adulte
- mésenchyme malin de l'adulte
- rhabdomyosarcome adulte
- sarcome utérin stade IV
- sarcome utérin récurrent
- léiomyosarcome utérin
- sarcome stromal de l'endomètre
- sarcome ovarien
- sarcome des tissus mous de l'adulte de stade III
- tumeur desmoplasique à petites cellules rondes de l'adulte
- carcinosarcome ovarien
Termes MeSH pertinents supplémentaires
- Maladies de la peau
- Tumeurs, tissus conjonctifs et mous
- Tumeurs par type histologique
- Tumeurs
- Tumeurs urogénitales
- Tumeurs par site
- Tumeurs utérines
- Tumeurs génitales, femme
- Maladies utérines
- Maladies du sein
- Tumeurs neuroectodermiques
- Tumeurs, cellules germinales et embryonnaires
- Tumeurs, tissu nerveux
- Tumeurs neuroendocrines
- Nevi et mélanomes
- Sarcome
- Tumeurs mammaires
- Tumeurs de la tête et du cou
- Tumeurs de l'endomètre
- Mélanome
Autres numéros d'identification d'étude
- EORTC-90061
- EUDRACT-2006-004529-27
- EORTC-90061-BI 1216.18
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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