- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01725555
A Study to Assess the Effect of Food on the Bioavailability of the IGF-1R Inhibitor AXL1717 in Patients With Advanced Malignant Tumors
A Randomized, Open-label, Phase I, Crossover Study to Assess the Effect of Food on the Bioavailability of AXL1717, in Patients With Advanced Malignant Tumors
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This is a randomized, crossover, open label, phase I study to assess the effect of food on the bioavailability of AXL1717 in advanced cancer patients.
A single, oral dose of AXL1717 is to be administered to patients on each of two occasions that are 7-day apart, in random order: after an overnight fast (fasted treatment) and with a high-fat or moderate-fat breakfast (fed treatment).
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Uppsala, Svezia
- KFUE
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Be informed of the nature of the study and have provided written informed consent
- At least 18 years of age
- Histologically confirmed diagnosis of advanced solid or hematological malignancy not amenable to standard treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 after optimization of analgesics
- Life expectancy ≥ 3 months
- Hematology values: blood leukocyte count ≥ 3.0 x 109/L, blood absolute neutrophil count ≥ 1.5 x 109/L, blood platelet count ≥ 100 x109/L, hemoglobin ≥ 100 g/L (transfusions are allowed)
- Clinical chemistry values: plasma total bilirubin level ≤ 1.5 times the upper limit of the "normal" range (ULN; i.e. reference), plasma AST or ALT ≤ 1.5 x ULN (≤5 times if liver metastases have been documented) and plasma creatinine ≤ 1.5 x ULN
- 12-lead ECG with normal tracings; or changes that are not clinically significant and do not require medical intervention
Exclusion Criteria:
- Ongoing infection or other major recent or ongoing disease that, according to the Investigator, poses an unacceptable risk to the patient
- Known primary or secondary central nervous system malignancy. (Patients with symptoms suggestive of possible CNS metastasis such as headache, dizziness or focal neurological deficits should undergo CT or MRI of the brain to rule out CNS metastasis. Patients who do not have CNS symptoms do not need a CT or MRI of the brain.)
- Grade 3 or higher constipation within the past 28 days or grade 2 constipation within the past 14 days before randomization. (Patients with grade 2 constipation within the past 14 days could be re-screened if constipation decreases to ≤ grade 1 with optimal management of constipation.)
- Impairment of gastrointestinal (GI) function, GI cancer or GI disease that may significantly alter the absorption of AXL1717
- Coexisting uncontrolled medical condition, including active cardiac disease (such as unstable angina, myocardial infarction within 6 months, or New York Heart Association Class III/IV congestive heart failure), or significant dementia
- Hepatic impairment as indicated by abnormalities of transaminases and/or alkaline phosphatase (AST and/or ALT > 1.5 × upper limit of normal concomitant with alkaline phosphatase > 2.5 × upper limit of normal, ≤5 times if liver metastases have been documented)
- Major surgical procedure within 4 weeks prior to randomization
- Use of potent inhibitors of CYP2C9 (e.g. Fluconazole) from 3 weeks prior to first administration of investigational product
- Women of child bearing potential (WOCBP) who do not consent to using acceptable methods of contraception (i.e. two of the following - oral contraception, barrier contraception, intrauterine device). For purposes of this study, WOCBP include any female who has experienced menarche, who has not undergone tubal ligation, and who is not postmenopausal. Post menopause is defined as: amenorrhea ≥ 12 consecutive months without another cause.
- Women who are breast-feeding or have a positive pregnancy test at screening
- Current participation in any other investigational clinical trial or any administration of an investigational agent within 4 weeks of study drug administration or 10 half-lives of the investigational agent, whichever is longer. Patients with unresolved investigational treatment-related AEs may not participate.
- Known or suspected hypersensitivity to AXL1717
- Lack of suitability for participation in the trial, for any reason, as judged by the Investigator
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Trattamento alimentato
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Sperimentale: Fasted treatment
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Single dose AXL1717 serum pharmacokinetic profile under fasting versus fed condition in each patient
Lasso di tempo: several samples within 24 hours
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several samples within 24 hours
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Safety of AXL1717 through adverse event reporting
Lasso di tempo: Up to 30 days after last dose of study drug
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Up to 30 days after last dose of study drug
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Simon Ekman, M.D., Ph.D., Uppsala University Hospital, Sweden
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
Termini MeSH pertinenti aggiuntivi
- Neoplasie per sede
- Malattie ematologiche
- Neoplasie
- Neoplasie ematologiche
- Meccanismi molecolari dell'azione farmacologica
- Agenti antineoplastici
- Modulatori della tubulina
- Agenti antimitotici
- Modulatori della mitosi
- Agenti antineoplastici, fitogenici
- Agenti dermatologici
- Agenti cheratolitici
- Podofillotossina
Altri numeri di identificazione dello studio
- AXL010
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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