- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Leuven, Belgio, B-3000
- U.Z. Gasthuisberg
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Mascheramento: Nessuno (etichetta aperta)
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
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Confirmed objective response rate (complete and partial responses) as defined by RECIST
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Misure di risultato secondarie
Misura del risultato |
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Sopravvivenza globale
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Durata della risposta
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Clinical benefit as assessed by RECIST
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Sopravvivenza globale libera da progressione
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Safety as assessed by CTCAE version 3.0
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Collaboratori e investigatori
Investigatori
- Cattedra di studio: Patrick Schoffski, MD, MPH, University Hospital, Gasthuisberg
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (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 (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
- carcinoma mammario in stadio IV
- carcinoma mammario ricorrente
- carcinoma del collo squamoso metastatico ricorrente con primario occulto
- carcinoma del collo squamoso metastatico con carcinoma a cellule squamose primitivo occulto
- carcinoma a cellule squamose ricorrenti del labbro e del cavo orale
- carcinoma a cellule squamose ricorrente dell'orofaringe
- carcinoma a cellule squamose ricorrenti dell'ipofaringe
- carcinoma a cellule squamose ricorrenti della laringe
- carcinoma a cellule squamose ricorrente del seno paranasale e della cavità nasale
- carcinoma epiteliale ovarico in stadio III
- carcinoma epiteliale ovarico in stadio IV
- carcinoma epiteliale ovarico ricorrente
- melanoma ricorrente
- melanoma al IV stadio
- angiosarcoma adulto
- fibrosarcoma adulto
- leiomiosarcoma adulto
- liposarcoma adulto
- neurofibrosarcoma adulto
- sarcoma sinoviale dell'adulto
- Sarcoma dei tessuti molli dell'adulto in stadio IV
- sarcoma ricorrente dei tessuti molli dell'adulto
- sarcoma alveolare delle parti molli dell'adulto
- sarcoma epitelioide dell'adulto
- istiocitoma fibroso maligno dell'adulto
- mesenchimoma maligno dell'adulto
- rabdomiosarcoma adulto
- Sarcoma uterino in stadio IV
- sarcoma uterino ricorrente
- leiomiosarcoma uterino
- sarcoma stromale endometriale
- sarcoma ovarico
- Sarcoma dei tessuti molli dell'adulto in stadio III
- tumore desmoplastico a piccole cellule rotonde dell'adulto
- carcinosarcoma ovarico
Termini MeSH pertinenti aggiuntivi
- Malattie della pelle
- Neoplasie, Connettivo e Tessuto Molle
- Neoplasie per tipo istologico
- Neoplasie
- Neoplasie urogenitali
- Neoplasie per sede
- Neoplasie uterine
- Neoplasie genitali, femmina
- Malattie uterine
- Malattie del seno
- Tumori neuroectodermici
- Neoplasie, cellule germinali ed embrionali
- Neoplasie, tessuto nervoso
- Tumori neuroendocrini
- Nevi e melanomi
- Sarcoma
- Neoplasie mammarie
- Neoplasie della testa e del collo
- Neoplasie endometriali
- Melanoma
Altri numeri di identificazione dello studio
- EORTC-90061
- EUDRACT-2006-004529-27
- EORTC-90061-BI 1216.18
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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