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A Study of LY2801653 in Advanced Cancer

19 febbraio 2018 aggiornato da: Eli Lilly and Company

A Phase 1 Study of LY2801653 in Patients With Advanced Cancer

Part A- The purpose of this study is to determine a safe dose of LY2801653 to be given to participants with advanced cancer and to determine any side effects that may be associated with LY2801653 in this participant population. Efficacy measures will be used to assess the activity of LY2801653.

Part B- The dose determined in Part A will be used along with efficacy measures to assess the activity of LY2801653 in participants with adenocarcinoma of the colon or rectum, head and neck squamous cell carcinoma (HNSCC), uveal melanoma with liver metastasis, and cholangiocarcinoma.

Part C - the objective of Part C is to determine a recommended Phase 2 dose of LY2801653 that may be safely given to participants with HNSCC when taken with standard doses of cetuximab Part D - the objective of Part D is to determine a recommended Phase 2 dose of LY2801653 that may be safely given to participants with cholangiocarcinoma when taken with a standard dose of cisplatin.

Part E - the objective of Part E is to determine a recommended Phase 2 dose of LY2801653 that may be safely given to participants with cholangiocarcinoma when taken with gemcitabine plus cisplatin.

Part F - the objective of Part F is to determine a recommended Phase 2 dose of LY2801653 that may be safely given to participants with gastric cancer when taken with ramucirumab.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Parts C and D were added to the registration in November, 2013, per protocol amendment. Parts E and F were added to the registration in February, 2015, per protocol amendment.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

190

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

  • Stati Uniti
    • Arizona
      • Tucson, Arizona, Stati Uniti, 85724
        • Arizona Cancer Center
    • District of Columbia
      • Washington, District of Columbia, Stati Uniti, 20007
        • Georgetown University Medical Center
    • New York
      • New York, New York, Stati Uniti, 10029
        • Mount Sinai Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, Stati Uniti, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • University of Pennsylvania Hospital
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti, 02903
        • Rhode Island Hospital

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:

  • Part A- Diagnosed with advanced and/or metastatic cancer during dose escalation
  • Part B- Diagnosed with adenocarcinoma of the colon or rectum, head and neck squamous cell carcinoma, uveal melanoma with liver with metastasis, or cholangiocarcinoma
  • Part C - Diagnosed with head and neck squamous cell carcinoma and have received at least one prior platinum-based systemic therapy
  • Part D - Diagnosed with cholangiocarcinoma and have not received more than 1 prior systemic therapy
  • Part E - Diagnosed with cholangiocarcinoma, either intrahepatic or extrahepatic, that is unresectable, recurrent, or metastatic. Participants must not have received prior systemic front line therapy for metastatic or resectable disease (i.e. participants may have received adjuvant gemcitabine but have not yet received gemcitabine/cisplatin for recurrent metastatic disease). Participants must be, in the opinion of the investigator, an appropriate candidate for experimental therapy. Participants should be evaluated for the need to undergo biliary drainage by stent placement prior to study participation. Participants should have adequate biliary drainage with no unresolved biliary obstruction.
  • Part F - Histologically- or cytologically-confirmed gastric carcinoma, including gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma (participants with adenocarcinoma of the distal esophagus are eligible if the primary tumor involves the GEJ). Participants must be ramucirumab naïve. Participants must be, in the opinion of the investigator, an appropriate candidate for experimental therapy. human epidermal growth factor receptor 2 (HER2)/neu status should be documented, if known.
  • Must be at least 18 years of age
  • Adequate hematologic, renal, and liver functions
  • Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
  • Ability to swallow capsules, with the exception of head and neck squamous cell carcinoma participants who may have study drug crushed and administered through a feeding tube

Exclusion Criteria:

  • Have serious preexisting medical conditions that would preclude participation in the study
  • Have a chronic underlying infection
  • Have symptomatic central nervous system (CNS) malignancy or metastasis
  • Have current acute or chronic leukemia
  • Are pregnant or lactating
  • Have hepatocellular cancer, liver cirrhosis with a Child-Pugh stage of B or higher, or have received a liver transplant
  • Have a history of congestive heart failure with a New York Heart Association class greater than 2, unstable angina, recent myocardial infarction (within 6 months of study enrollment), transient ischemic attacks, stroke, or arterial or venous vascular disease
  • Have a QTc interval greater than 470 msec
  • For participants in Part B, C, D, E, and F, a tumor tissue sample is mandatory, when safe and feasible, for biomarker analysis

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: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: LY2801653

This study consists of a dose escalation of LY2801653 (Part A) followed by dose confirmation cohorts in four tumor types (adenocarcinoma of the colon or rectum, head and neck squamous cell carcinoma, uveal melanoma with liver metastasis, and cholangiocarcinoma) (Part B).

Part C consists of dose determination for LY2801653 in combination with cetuximab in participants with head and neck squamous cell carcinoma followed by an expansion cohort.

Part D consists of dose determination for LY2801653 in combination with cisplatin in participants with cholangiocarcinoma followed by an expansion cohort.

Part E consists of dose determination for LY2801653 in combination with gemcitabine and cisplatin.

Part F consists of dose determination for LY2801653 in combination with ramicirumab.
Droga: LY2801653
LY2801653 given orally once daily during 28-day cycles. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met.
Droga: Cetuximab
Cetuximab given via IV infusion once weekly, 400mg/m2 for first dose and 250mg /m2 for subsequent doses. If LY2801653 treatment is stopped due to toxicity after a minimum of 4 cycles, cetuximab may be continued until disease progression. In the event cetuximab treatment is stopped, participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met.
Droga: Cisplatin
Cisplatin given via IV infusion once a week for 2 weeks and then every 3 weeks. If the LY2801653 is terminated for LY2801653-related toxicity after a minimum of 4 cycles, cisplatin may be continued as monotherapy until progression of disease. Participants discontinuing cisplatin therapy may be allowed to continue single agent LY2801653 if they are receiving clinical benefit.
Droga: Gemcitabine
Gemcitabine given via IV infusion once a week for 2 weeks and then every 3 weeks. If the LY2801653 is terminated for LY2801653-related toxicity after a minimum of 4 cycles, gemcitabine may be continued as monotherapy until progression of disease. Participants discontinuing gemcitabine therapy may be allowed to continue single agent LY2801653 if they are receiving clinical benefit.
Altri nomi:
  • Gemzar
  • LY188011
Droga: Ramucirumab
Ramucirumab given via IV infusion every 2 weeks in a 28-day treatment cycle. Treatment with ramucirumab may continue until excessive toxicity or evidence of disease progression. In the absence of disease progression, treatment with LY2801653 may continue even if ramucirumab is discontinued provided no dose limiting toxicity related to LY2801653 is present. In the event that LY2801653 is discontinued, treatment with ramucirumab may be continued if there is no dose limiting toxicity related to ramucirumab.
Altri nomi:
  • LY3009806
  • IMC-1121B
  • Cyramza

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Recommended dose for phase 2 studies: Maximum tolerated dose
Lasso di tempo: Baseline to study completion (estimated as 3 months)
Baseline to study completion (estimated as 3 months)

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Number of participants with tumor response
Lasso di tempo: Part A: Baseline to study completion (estimated as 3 months)
Part A: Baseline to study completion (estimated as 3 months)
Clinical benefit rate (CBR)
Lasso di tempo: Parts B, C, D: Baseline to study completion (estimated as 3 months)
Parts B, C, D: Baseline to study completion (estimated as 3 months)
Progression free survival (PFS)
Lasso di tempo: Parts B, C, D: Baseline to study completion (estimated as up to 6 months)
Parts B, C, D: Baseline to study completion (estimated as up to 6 months)
Duration of response
Lasso di tempo: Parts B, C, D: Baseline to study completion (estimated as up to 6 months)
Parts B, C, D: Baseline to study completion (estimated as up to 6 months)
Number of participants with clinically significant effects
Lasso di tempo: Baseline to study completion (estimated as 3 months)
Baseline to study completion (estimated as 3 months)
Pharmacokinetics: Area under the concentration/time curve (AUC)
Lasso di tempo: Cycle 1, Day 1; Cycle 2, Day 1
Cycle 1, Day 1; Cycle 2, Day 1
Pharmacokinetics: Maximum plasma concentration (Cmax)
Lasso di tempo: Cycle 1, Day 1; Cycle 2, Day 1
Cycle 1, Day 1; Cycle 2, Day 1
Maximum tolerated dose (MTD) of LY2801653 in combination with cetuximab for phase 2 studies in HNSCC
Lasso di tempo: Baseline to study completion (estimated as 3 months)
Baseline to study completion (estimated as 3 months)
Maximum tolerated dose (MTD) of LY2801653 in combination with cisplatin for phase 2 studies in cholangiocarcinoma
Lasso di tempo: Baseline to study completion (estimated as 3 months)
Baseline to study completion (estimated as 3 months)
Maximum tolerated dose (MTD) of LY2801653 in combination with gemcitabine plus cisplatin for phase 2 studies in cholangiocarcinoma
Lasso di tempo: Baseline to study completion (estimated as 3 months)
Baseline to study completion (estimated as 3 months)
Maximum tolerated dose (MTD) of LY2801653 in combination with ramucirumab for phase 2 studies in gastric carcinoma
Lasso di tempo: Baseline to study completion (estimated as 3 months)
Baseline to study completion (estimated as 3 months)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Eli Lilly and Company

Investigatori

  • Direttore dello studio: Call 1-877-CTLILLY (1-817-285-4559) or 1-317-615-4559 Mon - Fri 9AM to 5PM Eastern time (UTC/GMT - 5hours, EST), Eli Lilly and Company

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

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 (Effettivo)

9 settembre 2009

Completamento primario (Effettivo)

21 luglio 2017

Completamento dello studio (Effettivo)

11 settembre 2017

Date di iscrizione allo studio

Primo inviato

26 gennaio 2011

Primo inviato che soddisfa i criteri di controllo qualità

26 gennaio 2011

Primo Inserito (Stima)

27 gennaio 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 febbraio 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 febbraio 2018

Ultimo verificato

1 febbraio 2018

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 13008
  • I3O-MC-JSBA (Altro identificatore: Eli Lilly and Company)

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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