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- Sperimentazione clinica NCT01226732
A Study of the Hsp90 Inhibitor AUY922 Plus Capecitabine for the Treatment of Patients With Advanced Solid Tumors
15 febbraio 2022 aggiornato da: SCRI Development Innovations, LLC
A Phase I Study of the Hsp90 Inhibitor AUY922 Plus Capecitabine for the Treatment of Patients With Advanced Solid Tumors
The investigators propose this Phase I trial of the combination of AUY922 and capecitabine to determine the maximum tolerated dose (MTD) in patients with advanced solid tumors.
This combination treatment has potential applicability in tumor types where capecitabine or fluorouracil is a treatment option, including colorectal and breast cancer.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
23
Fase
- 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
-
-
Florida
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Fort Myers, Florida, Stati Uniti, 33916
- Florida Cancer Specialists
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-
Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 71304
- Oklahoma University
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37203
- Tennessee Oncology
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-
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
Tutto
Descrizione
Inclusion Criteria:
- Histologically confirmed metastatic or unresectable solid tumor malignancy that is incurable and for which capecitabine is clinically appropriate.
- Patient must be ≥4 weeks from administration of last dose of cancer therapy (including radiation therapy, biologic therapy, hormonal therapy or chemotherapy). Patients who received a small molecule targeted therapy as part of their first line treatment regimen must be ≥4 weeks or ≥5 half lives from administration of last dose whichever is shorter. The patient must have recovered from or come to a new chronic stable baseline from all treatment-related toxicities.
- Eastern Collaborative Oncology Group (ECOG) performance status 0 to 1 (see Appendix A).
- Life expectancy of ≥3 months.
- At least one unidimensional measurable lesion definable by MRI or CT scan. Disease must be measurable per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria (see Section 9).
Normal bone marrow function defined as:
- Absolute neutrophil count (ANC) ≥1500/μL
- Hemoglobin (Hgb) ≥9 g/dL
- Platelets ≥100,000/μL
Adequate hepatic function defined as:
- AST or ALT and alkaline phosphatase (ALP) must be ≤3 x ULN, or ≤5 x ULN in patients with liver metastases
- Total bilirubin ≤1.5 x the institutional ULN
Renal function defined as:
• Serum creatinine ≤1.5 x ULN or 24-hour creatinine clearance ≥40 mL/min
Normal electrolytes defined as:
- Phosphorous ≥ LLN
- Magnesium ≥ LLN
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment. Women of childbearing potential must use effective birth control measures during treatment and during the 6 months following completion of study treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
- Must be ≥18 years of age.
- Patients must be accessible for treatment and follow-up.
- Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.
Exclusion Criteria:
- Untreated CNS metastases. Patients with treated CNS metastases may be enrolled, provided the patient is asymptomatic, and the patient does not require antiepileptic drugs or steroids as treatment for the CNS metastases.
- Treatment with therapeutic doses of coumarin-type anticoagulants (maximum daily dose of 1 mg allowed for port line patency permitted).
Impaired cardiac function with any one of the following:
- History (or family history) of long QT syndrome
- Mean QTc ≥450 msec on baseline ECG
- History of clinically manifested ischemic heart disease (i.e. myocardial infarction and/or unstable angina) ≤6 months prior to study start
- History of heart failure or left ventricular (LV) dysfunction (LVEF ≤45%) by MUGA or ECHO
- Clinically significant ECG abnormalities including 1 or more of the following: left bundle branch block (LBBB), right bundle branch block (RBBB) with left anterior hemiblock (LAHB). ST segment elevation or depression > 1mm, or 2nd (Mobitz II), or 3rd degree AV block.
- History or presence of atrial fibrillation, atrial flutter or ventricular arrhythmias including ventricular tachycardia or Torsades de Pointes
- Other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
- Clinically significant resting bradycardia (< 50 beats per minute)
- Patients who are currently receiving treatment with any medication which has a relative risk of prolonging the QTcF interval or inducing Torsades de Pointes and cannot be switched to an alternative drug or discontinued prior to commencing AUY922 (see Appendix D).
- Obligate use of a cardiac pacemaker
- Impairment of gastrointestinal function or gastrointestinal disease that in the opinion of the Investigator may significantly alter the absorption of study drugs (e.g., Crohn's disease, ulcerative disease, uncontrolled vomiting, diarrhea, or malabsorption syndrome).
- Patients with known diagnosis of human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection.
- Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
- Women who are pregnant (positive pregnancy test) or lactating.
- Any condition that would prevent patient comprehension of the nature of, and risk associated with, the study, and the inability to comply with study and/or follow-up procedures.
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: Dose Level 1
Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
|
Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Altri nomi:
IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Sperimentale: Dose Level 2
Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
|
Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Altri nomi:
IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Sperimentale: Dose Level 3
Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
|
Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Altri nomi:
IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Sperimentale: Dose Level 4
Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
|
Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Altri nomi:
IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Sperimentale: Dose Level 5
Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
|
Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Altri nomi:
IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Sperimentale: Dose Level 6
Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles
|
Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Altri nomi:
IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Dose Determination
Lasso di tempo: 18 months
|
To determine the maximum tolerated dose (MTD) of AUY922 plus capecitabine in patients with advanced solid tumors.
|
18 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Drug Related Toxicities
Lasso di tempo: 18 months
|
To evaluate the drug related toxicities associated with different doses of the drugs used in this regimen.
|
18 months
|
Preliminary Efficacy Assessment: Response Rate (RR)
Lasso di tempo: 18 months
|
Response Rate (RR) is defined as the total number of patients with Complete Response (CR) or Partial Response (PR) as defined in RECIST v2.
CR is defined as the dissappearance of all target lesions, disappearance of all non-target lesions and normalization of tumor markers.
PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
|
18 months
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Cattedra di studio: Johanna C Bendell, MD, SCRI Development Innovations, LLC
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 novembre 2010
Completamento primario (Effettivo)
1 luglio 2013
Completamento dello studio (Effettivo)
1 giugno 2014
Date di iscrizione allo studio
Primo inviato
18 ottobre 2010
Primo inviato che soddisfa i criteri di controllo qualità
20 ottobre 2010
Primo Inserito (Stima)
22 ottobre 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
8 marzo 2022
Ultimo aggiornamento inviato che soddisfa i criteri QC
15 febbraio 2022
Ultimo verificato
1 febbraio 2022
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SCRI GI 143
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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