- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00858403
Dasatinib in Advanced Non-small Cell Lung Cancer (NSCL) With Ex Vivo and In Vivo Assessment of Tumor Target Modulation
Phase II Study of Dasatinib in Advanced Non-small Cell Lung Cancer With Ex Vivo and In Vivo Assessment of Tumor Target Modulation
Panoramica dello studio
Descrizione dettagliata
Cycle 1 Day 1 (C1D1): Patients will have complete history and physical (H&P), complete blood count (CBC), complete metabolic panel (CMP) and electrocardiogram (EKG) on day 1. Each cycle is 28 days. The C1D1 EKG can be omitted if the patient has no new cardiac symptoms and has not starting taking any medication known to affect QT corrected for heart rate (QTc) prolongation. Any residual toxicity from prior therapy for cancer will be recorded. Blood will be drawn for assessment of serum markers. The patient will begin dasatinib at the starting C1D1 on a daily basis.
Cycle 1 Day 10-20 (C1D10-20): Patients will have a second biopsy to obtain additional tumor material to examine biological effects of dasatinib on signaling pathways. Dasatinib will be taken first thing in the morning and the patient will log the time. Blood will also be drawn for pharmacokinetic assessments of dasatinib levels in plasma and the time recorded. Four FNA aspirates and 2 core biopsies can be obtained either at the bedside for palpable lesions or through appropriate image-guided techniques (CT or US) at the discretion of the treating physician in consultation with radiology. The time of the biopsy will be recorded. One core biopsy should be immediately fixed in formalin and the other core biopsy should be snap frozen in liquid nitrogen.
Cycle 2 Day 1 (C2D1): Patients will be seen by the treating physician and have complete H&P, CBC, and CMP. Blood will be drawn for assessment of serum markers. Toxicity of dasatinib will be assessed. The patient will continue to take daily doses of dasatinib on a daily basis.
Cycle 2 Day 22 (C2D22): Patients will undergo reevaluation for tumor measurements. This assessment can occur on C2D22 ±7 days.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Florida
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Tampa, Florida, Stati Uniti, 33612
- H. Lee Moffitt Cancer Center & Research 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 or cytologically documented diagnosis of NSCLC that is advanced/metastatic (Stage IIIB/IV).
- Performance Status (ECOG) 0-2
- Previous chemotherapy with the exception of dasatinib. Patients who have had any type of previous chemotherapy regimens for non-small cell lung cancer are eligible.
Adequate Organ Function:
- Total bilirubin < 2.0 times the institutional Upper Limit of Normal (ULN)
- Hepatic enzymes (AST, ALT ) ≤ 2.5 times the institutional ULN
- Serum Na, K+, Mg2+, Phosphate and Ca2+≥ Lower Limit of Normal (LLN)
- Serum Creatinine < 1.5 time the institutional ULN
- Hemoglobin, Neutrophil count, Platelets, prothrombin time (PT), partial thromboplastin time (PTT) all Grade 0-1
- Ability to take oral medication
Concomitant Medications:
- Agree to discontinue St. Johns Wort while receiving dasatinib therapy
- Agree that IV bisphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia.
Women of childbearing potential (WOCBP):
- A negative serum or urine pregnancy test within 72 hours prior to the start of study drug administration
- Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped Prior to study enrollment.
- Signed written informed consent including a HIPAA form according to institutional Guidelines
Exclusion Criteria:
- No malignancy [other than the one treated in this study] which required radiotherapy or systemic treatment within the past 5 years.
- Prior dasatinib therapy.
Concurrent medical condition which may increase the risk of toxicity, including:
- Patients with severe pulmonary disease that increases the risk of toxicity related to dasatinib-induced pleural effusions. This includes chronic obstructive pulmonary disease or pleural effusions (malignant or benign) requiring chronic oxygen therapy or patients that have had prior pneumonectomy. Patients that have a pulmonary embolism and require oxygen therapy will be excluded but not those patients who have a pulmonary embolism but do not require oxygen therapy. Patients with active pleural effusions not controlled with pleurodesis will be excluded.
Cardiac Symptoms; any of the following should be considered for exclusion:
- Uncontrolled angina, congestive heart failure or MI within (6 months)
- Diagnosed congenital long QT syndrome
- Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
- Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec)
- Patients with hypokalemia or hypomagnesemia if it cannot be corrected prior to dasatinib administration
History of significant bleeding disorder unrelated to cancer, including:
- Diagnosed congenital bleeding disorders
- Diagnosed acquired bleeding disorder within one year
- Ongoing or recent (≤ 3 months) significant gastrointestinal bleeding
Concomitant Medications, any of the following should be considered for exclusion:
Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib)
- quinidine, procainamide, disopyramide
- amiodarone, sotalol, ibutilide, dofetilide
- erythromycin, clarithromycin
- chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide
- cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.
Women:
- unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug,or
- have a positive pregnancy test at baseline
- pregnant or breastfeeding
- Prisoners or persons who are compulsorily detained (involuntarily incarcerated)for treatment of either a psychiatric or physical (e.g., infectious) illness
- Patients on systemic anticoagulation at risk of bleeding related to tumor biopsy that cannot be off anticoagulation per the discretion of their physician.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Treatment with Dasatinib
Dasatinib 140 mg orally (po) every day starting Day #1, continuous dosing.
This dose was chosen based on the current experience in patients with solids tumors who have had prior chemotherapy.
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Take tablets of Dasatinib by mouth once a day.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Number of Participant Progressors vs. Non-progressors With Tumor Response
Lasso di tempo: 1 year, 4 months
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We planned to assess whether the extent of inhibition of extracellular signal-regulated protein kinase (ERK) phosphorylation in lung cancer cells exposed ex vivo to dasatinib significantly differed between patients categorized as progressors or non-progressors through standard Response Evaluation Criteria In Solid Tumors (RECIST)
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1 year, 4 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Number of Participants With Response to Dasatinib
Lasso di tempo: 1 year, 4 months
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We planned to estimate the single agent response rate to dasatinib in this patient population
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1 year, 4 months
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Number of Participants With Progression Free Survival (PFS) at 6 Months
Lasso di tempo: 1 year, 4 months
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We planned to estimate the 6 month progression free survival rate of dasatinib in this patient population.
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1 year, 4 months
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Number of Participants With Serious Adverse Events (SAEs)
Lasso di tempo: 1 year, 4 months
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We evaluated toxicity of dasatinib in this patient population.
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1 year, 4 months
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Number of Participant Progressors vs. Non-Progressors With Inhibition Response
Lasso di tempo: 1 year, 4 months
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We planned to assess whether the extent of inhibition of proto-oncogene tyrosine-protein kinase (SRC) and protein kinase B (Akt) phosphorylation in lung cancer cells exposed ex vivo and in vivo to dasatinib significantly differs between patients categorized as progressors or non-progressors through standard RECIST criteria.
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1 year, 4 months
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Correlation Between Extent of Inhibition and Concentration of Dasatinib
Lasso di tempo: 1 year, 4 months
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We planned to explore whether the extent of inhibition of ERK, SRC and Akt phosphorylation in lung cancer cells exposed ex vivo to dasatinib will correlate with the drug concentration of dasatinib.
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1 year, 4 months
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Correlation Between Mutation and Inhibition and to Disease Control Rate and Response
Lasso di tempo: 1 year, 4 months
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To analyze Kras and epidermal growth factor receptor (EGFR) mutation and their correlation to the ERK pathway inhibition and to disease control rate and response.
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1 year, 4 months
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Eric Haura, M.D., H. Lee Moffitt Cancer Center and Research Institute
Pubblicazioni e link utili
Collegamenti utili
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 (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie delle vie respiratorie
- Neoplasie
- Malattie polmonari
- Neoplasie per sede
- Neoplasie delle vie respiratorie
- Neoplasie toraciche
- Carcinoma, broncogeno
- Neoplasie bronchiali
- Neoplasie polmonari
- Carcinoma, polmone non a piccole cellule
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Agenti antineoplastici
- Inibitori della chinasi proteica
- Dasatinib
Altri numeri di identificazione dello studio
- MCC-15656
- CA180214 (Altro identificatore: Bristol-Myers Squibb)
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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