- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01287546
A Study of LY2875358 in Participants With Advanced Cancer
A Phase 1 Study of LY2875358 in Patients With Advanced Cancer
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
-
-
California
-
La Jolla, California, Stati Uniti, 92037-0845
- University of California - San Diego
-
Los Angeles, California, Stati Uniti, 90048-5615
- Cedars Sinai Medical Center
-
San Francisco, California, Stati Uniti, 94115
- Univ of California San Francisco
-
Santa Monica, California, Stati Uniti, 90404
- UCLA
-
-
Florida
-
Jacksonville, Florida, Stati Uniti, 32224
- Mayo Clinic of Jacksonville
-
-
Georgia
-
Atlanta, Georgia, Stati Uniti, 30322
- Emory University
-
-
Massachusetts
-
Boston, Massachusetts, Stati Uniti, 02114
- Massachusetts General Hospital
-
-
Michigan
-
Ann Arbor, Michigan, Stati Uniti, 48109-0946
- University of Michigan
-
-
Minnesota
-
Rochester, Minnesota, Stati Uniti, 55902
- Mayo Clinic
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Stati Uniti, 19107
- Thomas Jefferson University
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Part A: Have histological or cytological evidence of cancer (solid tumor, lymphoma, or multiple myeloma) that is advanced and/or metastatic and an appropriate candidate for experimental therapy
- Part A2: Histologic or cytologic diagnosis of advanced Non Small Cell Lung Cancer (NSCLC), Stage IIIB with malignant pleural effusion or Stage IV, completed at least 1 prior systemic regimen, and eligible for erlotinib therapy.
- Part B: Candidate for experimental therapy after standard therapies used or non-eligible for standard therapies. Histological or cytological evidence of 1 of the 5 tumor types:
Castrate-resistant prostate cancer (CRPC) with bone metastasis:
--Progressive Disease in the setting of castrate level of testosterone
Renal Cell Carcinoma (RCC):
--Histologic diagnosis of either clear-cell or papillary RCC (metastatic and unresectable, or bilateral, multifocal, unresectable RCC localized to kidneys).
NSCLC:
--Histologic or cytologic diagnosis of advanced NSCLC, Stage IIIB with malignant pleural effusion or Stage IV
Hepatocellular Carcinoma (HCC)
--Histologic or cytologic diagnosis of hepatocellular carcinoma
- Uveal Melanoma with liver metastasis
- Part A: Have the presence of measurable or nonmeasurable disease as defined by the RECIST v1.1 (Eisenhauer et al. 2009) or Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007) or have measureable disease for multiple myeloma.
- Part A2 & B (RCC, NSCLC, HCC, and uveal melanoma): Have measurable disease as defined by RECIST v1.1.
- Give written informed consent prior to any study-specific procedures.
- Adequate organ function.
- Performance status of less than or equal to 2 on ECOG scale.
- Discontinued all previous cancer therapies, and any agents that have not received regulatory approval, for at least 21 days and recovered from the acute effects of therapy. Must have discontinued mitomycin-C or nitrosourea therapy for at least 42 days.
- Reliable and available for the duration of the study and willing to follow study procedures.
- Males and females (reproductive potential): Use medically approved contraceptive precautions during the study and for 4 months following the last dose of study drug.
- Females (childbearing potential): Have had a negative serum pregnancy test before the first dose of study drug and not be breast-feeding.
- Estimated life expectancy that will permit the participants to complete 8 weeks of treatment.
Exclusion Criteria:
- Serious preexisting medical conditions
- Symptomatic central nervous system malignancy or metastasis (screening not required).
- Acute or chronic leukemia.
- Active infection including HIV, hepatitis A, B or C
- Have second primary malignancy that may affect the interpretation of results.
- Have received a liver transplant, or have liver cirrhosis with a Child-Pugh Stage of B or C.
- Patients with active alcohol abuse, as determined by the treating investigator.
- Part A2: Unable to swallow tablets. Intolerant of therapy with erlotinib. Concomitant treatment with the cytochrome P450 3A (CYP3A) modulators. Must not have received treatment with any of these modulators within 14 days of study treatment.
- Have a history of New York Heart Association class ≥3, unstable angina, myocardial infarction 6 months prior to study drug
- QTc greater than 470 msec.
- Received previous treatment with any c-MET experimental therapeutic.
Part B Expansion Cohort 1 (CRPC):
- Increasing use of daily doses of opioid analgesics within 28 days prior to enrollment in the study.
- Neuroendocrine prostate cancer.
- Patients who have a solitary bone metastasis that has been irradiated are not eligible.
- Part B Expansion Cohort 6 (LY2875358 plus trametinib in participants with uveal melanoma with liver metastasis): Contra-indications for trametinib
Piano di studio
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: LY2875358
|
Part A Dose escalation of LY2875358 administered intravenously (IV), Day 1 and 15 every 28 days for at least two cycles.
|
Sperimentale: LY2875358 + erlotinib
|
Part A2 Dose escalation of LY2875358 administered IV, on Day 1 and 15 every 28 days for at least two cycles in combination with daily erlotinib dosing (150 mg) taken orally (PO).
|
Sperimentale: LY2875358 at Part A highest dose
|
Part B (Dose Exploration): LY2875358 at Part A highest dose administered IV, on Day 1 and 15 every 28 days for at least two cycles.
|
Sperimentale: LY2875358 at Part A highest dose + trametinib
|
Part B (in combination with trametinib): LY2875358 at Part A highest dose administered IV, on Day 1 and 15 every 28 days for at least two cycles, in combination with trametinib at 2 mg orally once daily
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Recommended Phase 2 dose range of LY2875358 monotherapy and in combination with erlotinib
Lasso di tempo: Baseline through Cycle 1
|
Baseline through Cycle 1
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Pharmacokinetics: Maximum plasma concentration (Cmax)
Lasso di tempo: Days 1, 2, 4, 5, 6, 8, 15, and 22 of Cycle 1. Days 1, 15, and 22 of Cycle 2. Days 1 and 15 of Cycles 3 and beyond, as well as 14 days, 29 days, and 57 days following the final treatment
|
Days 1, 2, 4, 5, 6, 8, 15, and 22 of Cycle 1. Days 1, 15, and 22 of Cycle 2. Days 1 and 15 of Cycles 3 and beyond, as well as 14 days, 29 days, and 57 days following the final treatment
|
Number of participants with a tumor response
Lasso di tempo: Baseline to study completion (12 months)
|
Baseline to study completion (12 months)
|
Pharmacokinetics: Area under the concentration-time curve (AUC)
Lasso di tempo: Days 1, 2, 4, 5, 6, 8, 15, and 22 of Cycle 1. Days 1, 15, and 22 of Cycle 2. Days 1 and 15 of Cycles 3 and beyond, as well as 14 days, 29 days, and 57 days following the final treatment
|
Days 1, 2, 4, 5, 6, 8, 15, and 22 of Cycle 1. Days 1, 15, and 22 of Cycle 2. Days 1 and 15 of Cycles 3 and beyond, as well as 14 days, 29 days, and 57 days following the final treatment
|
Time to progression and overall survival
Lasso di tempo: Baseline to study completion (12 months)
|
Baseline to study completion (12 months)
|
Pharmacokinetics: Area under the concentration-time curve (AUC) of erlotinib or trametinib in combination with LY2875358
Lasso di tempo: Cycle 1
|
Cycle 1
|
Change from baseline in Brief Pain Inventory (BPI) in Part B: Expansion Cohort 1
Lasso di tempo: Baseline to study completion (12 months)
|
Baseline to study completion (12 months)
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
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 (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
- 13298
- I4C-MC-JTBA (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 .
Prove cliniche su Cancro avanzato
-
Rush University Medical CenterCompletatoAdvanced Cardiac Life Support, rianimazione cardiopolmonare, volume corrente, ventilazione manualeStati Uniti
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletatoAdenocarcinoma dell'intestino tenue | Adenocarcinoma dell'intestino tenue in stadio III AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIA AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIB AJCC v8 | Adenocarcinoma dell'intestino tenue stadio IV AJCC v8 | Ampolla di Vater... e altre condizioniStati Uniti
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...CompletatoStudio delle donne cinesi che non hanno aderito alle linee guida per lo screening mammografico dell'American Cancer SocietyStati Uniti
-
National Cancer Institute (NCI)ReclutamentoKita-kyushu Lung Cancer Antigen 1, umanoStati Uniti
-
The Leeds Teaching Hospitals NHS TrustAttivo, non reclutanteFerite e lesioni | Chirurgia | Riabilitazione | Disturbo ortopedico | Misure di esito riferite dal paziente | Valutazione della disabilità | Recupero della funzione | Trauma multiplo/lesioni | Centri traumatologici | Indici di gravità del trauma | Advanced Trauma Life Support CareRegno Unito
-
Novartis PharmaceuticalsReclutamentoEGFR mutante avanzato Non SmallSellLung Cancer (NSCLC), KRAS G12-mutant NSCLC, Esophageal SquamousCell Cancer (SCC), Head/Neck SCC, MelanomaOlanda, Corea, Repubblica di, Spagna, Taiwan, Giappone, Italia, Canada, Stati Uniti, Singapore
-
Advanced BionicsCompletatoPerdita dell'udito da grave a profonda | negli utenti adulti di Advanced Bionics HiResolution™ Bionic Ear SystemStati Uniti
-
Emory UniversityNational Cancer Institute (NCI)RitiratoCancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nel cervello | Carcinoma mammario metastatico | Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
-
NRG OncologyNational Cancer Institute (NCI)Attivo, non reclutanteCancro al seno in stadio anatomico IV AJCC v8 | Cancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nell'osso | Neoplasia maligna metastatica nei linfonodi | Neoplasia maligna metastatica nel fegato | Carcinoma mammario metastatico | Neoplasia maligna metastatica nel... e altre condizioniStati Uniti, Canada, Arabia Saudita, Corea, Repubblica di
-
Jonsson Comprehensive Cancer CenterNon ancora reclutamentoCarcinoma della prostata | Stadio IVB Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
Prove cliniche su LY2875358
-
Eli Lilly and CompanyCompletatoTumore gastricoGiappone, Corea, Repubblica di
-
Eli Lilly and CompanyCompletatoCarcinoma a cellule renali | Carcinoma polmonare non a piccole cellule | Adenocarcinoma gastrico | Cancro avanzato | Cancro epatocellulare | Adenocarcinoma della giunzione gastroesofageaStati Uniti
-
Eli Lilly and CompanyAttivo, non reclutanteCarcinoma, polmone non a piccole celluleSpagna, Taiwan, Regno Unito, Francia, Germania, Olanda, Corea, Repubblica di, Italia, Danimarca
-
Eli Lilly and CompanyCompletatoCarcinoma, polmone non a piccole celluleStati Uniti, Germania, Spagna, Belgio, Francia, Regno Unito, Olanda, Italia, Israele, Corea, Repubblica di
-
Eli Lilly and CompanyCompletatoLinfoma | Carcinoma, polmone non a piccole cellule | Tumori solidiGiappone