- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04921904
Abemaciclib Plus Ramucirumab for Esophageal/Gastroesophageal Junction Ca
Phase I/II Study of Abemaciclib + Ramucirumab in Metastatic Esophageal/Gastroesophageal Junction Carcinomas
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This is a multicenter, open label, phase I/II safety study that will enroll 30 subjects with metastatic esophageal and gastroesophageal junction adenocarcinomas post first line systemic chemotherapy. Subjects will be treated with oral Abemaciclib 150 mg PO daily bid given with ramucirumab 8mg/kg every 2 weeks iv until evidence of disease progression or unacceptable toxicities.
A total of 30 subjects will be enrolled. The primary goal is to describe the safety profile of Abemaciclib in combination with Ramucirumab among all enrolled subjects.
If grade 3 or higher treatment-related adverse events occur in 20 subjects, the upper bound of 95% Wilson confidence interval for the adverse event rate would be below 81% (16.7% - 47.9%).
The safety analysis will be performed in all treated subjects. Adverse event data will be listed individually and graded according to the National Cancer Institute Common Terminology Criteria, version 4.03.
Summary statistics will include counts and proportions as well as rates with 95% confidence intervals. Toxicities will be reported as a tabulated table by type and grade.
Objective response rate is defined as the percentage of subjects who achieve an objective response by RECIST1.1 criteria (i.e. Complete response or Partial Response) to Abemaciclib in combination with Ramucirumab. We will estimate the objective response rate, along with the Wilson 95% confidence interval, for the population of subjects.
Overall survival will be defined as the time from study enrollment to death. This will be summarized using a Kaplan-Meier curve.
The proportion of subjects with grade 4 or higher treatment-related adverse events will be monitored continuously throughout the trial using a Bayesian stopping guideline. A Beta (1, 19) prior, representing a toxicity rate of 5%, slightly lower than the expected rate of 6%, was used in the development of our guidelines. The therapy will be re-evaluated if the posterior probability that the toxicity rate exceeds 10% is greater than 75%. Table 3 summarizes the stopping boundaries starting with the initial cohort of 3 subjects through the maximum sample size of 30 subjects.
The probability of triggering the stopping guidelines was assessed for a range of possible toxicity rates using simulations with 5000 replicates. The probability of stopping to re-evaluate was 1% if the true proportion with an unacceptable toxicity was 5%. In comparison, the probability of stopping early was 99.6% if the true proportion with an unacceptable toxicity was 40%
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 2
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: Heather Williams, MS
- Numero di telefono: (214) 818-7879
- Email: Heather.Williams1@BSWHealth.org
Backup dei contatti dello studio
- Nome: Joyce Ghormley
- Numero di telefono: (214) 818-8961
- Email: Joyce.Ghormley@BSWHealth.org
Luoghi di studio
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Texas
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Dallas, Texas, Stati Uniti, 75246
- Baylor University Medical Center, Charles A Sammons Cancer Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Subjects must meet all eligibility criteria. The key inclusion and exclusion criteria are as follows:
Key Inclusion Criteria:
- All subjects must have metastatic esophageal or gastroesophageal junction carcinomas (adenocarcinoma only)
- ECOG performance status of 0 or 1
- Tumor tissue must be available for correlative studies - Either a formalin fixed paraffin block or a minimum of ten 5-micron tissue section's (slides) of tumor biopsy sample must be available for biomarker evaluation.
- Patients must have received at least one prior line of standard systemic therapy for recurrent or Stage IV disease, and that patients with HER2 overexpression have received an anti-HER2 drug.
Key Exclusion Criteria:
- Squamous cell carcinomas
- Mixed histology with small cell component
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 |
---|---|
Sperimentale: Abemaciclib plus Ramucirumab
Abemaciclib 150mg dose administered orally twice daily every day plus Ramucirumab dose 8mg/kg iv every 2 weeks until evidence of disease
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150mg dose administered orally twice daily every day
8mg/kg iv every 2 weeks until evidence of disease
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
To describe the safety profile of Abemaciclib + Ramucirumab as assessed according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).
Lasso di tempo: 24 months
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24 months
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
To assess objective response rate
Lasso di tempo: 24 months
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24 months
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To assess progression free survival
Lasso di tempo: 24 months
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24 months
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To assess overall survival
Lasso di tempo: 24 months
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24 months
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To determine the rate of stable disease at 3 months post targeted therapy
Lasso di tempo: 24 months
|
24 months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Ronan Kelly, MD, Charles A Sammons Cancer Center/Texas Oncology
Studiare le date dei record
Studia le date principali
Inizio studio (Anticipato)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 020-055
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
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prodotto fabbricato ed esportato dagli Stati Uniti
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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