- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01253525
Study of Weekly Paclitaxel With Ramucirumab in Participants With Advanced Gastric Adenocarcinomas
16 maggio 2014 aggiornato da: Eli Lilly and Company
A Phase 1b Study of Weekly Paclitaxel With Ramucirumab (IMC-1121B) Drug Product in Patients With Advanced Gastric Adenocarcinomas
Investigate the safety and tolerability of ramucirumab (IMC-1121B) drug product (DP) in combination with paclitaxel.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
6
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
-
-
-
Chiba, Giappone, 277-8577
- ImClone Investigational Site
-
Osaka, Giappone, 569-8686
- ImClone Investigational Site
-
Osaka, Giappone, 589-5811
- ImClone Investigational Site
-
-
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
20 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Has a histopathologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma
- Has an advanced or metastatic solid gastric adenocarcinoma that has failed standard therapy
- Has resolution of all clinically significant toxic effects of prior therapy, surgery, treatment with an investigational agent or device, treatment monoclonal antibody or small molecule, and radiotherapy or chemotherapy.
- Has adequate organ function
- Eligible participants of reproductive potential (both sexes) agree to use adequate contraceptive methods (hormonal or barrier methods) during the study period and for 12 weeks after the last dose of study medication
Exclusion Criteria:
- Has undergone major surgery within 28 days prior to the study, or subcutaneous venous access device placement within 7 days prior to the study registration date
- Has elective or planned surgery to be conducted during the trial
- Has had treatment with an investigational agent or device, an antineoplastic small molecule, or antineoplastic radiotherapy or chemotherapy
- Was previously treated with a chemotherapy regimen containing nitrosoureas or mitomycin C
- Has had treatment with an antineoplastic monoclonal antibody within 8 weeks prior to the study registration date
- Has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism prior to the study registration date
- Has experienced any arterial thrombotic event, including myocardial infarction, cerebrovascular accident, or transient ischemic attack, within 6 months prior to the study date
- Is receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin or similar agents. (Participants receiving prophylactic, low-dose anticoagulation therapy are eligible provided that the coagulation parameters International Normalized Ratio (INR) ≤ 1.5, prothrombin time (PT) and partial thromboplastin time (PTT) or - Is receiving chronic therapy with nonsteroidal anti-inflammatory agents [Aspirin use at doses up to 325 milligrams/day (mg/day) is permitted]
- Has significant bleeding disorders, vasculitis, history of postoperative bleeding complications, hemoptysis or had a significant bleeding episode from the gastrointestinal (GI) tract within 3 months prior to the study date
- Has a history of GI perforation and/or fistulae within 6 months prior to the study date
- Has symptomatic congestive heart failure, unstable angina pectoris, or symptomatic or poorly controlled cardiac arrhythmia
- Has uncontrolled arterial hypertension despite standard medical management.
- Has a serious or nonhealing wound or peptic ulcer or bone fracture within 28 days prior to the study date
- Has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection, Crohn's disease, ulcerative colitis, or chronic diarrhea
- Has a serious illness or medical condition(s)
- Is pregnant or lactating
- Has received treatment with another investigational drug or participation in another interventional clinical trial within 28 days prior to the study date
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: Ramucirumab (IMC-1121B ) and Pacitaxel
Each treatment cycle is 4 weeks (28 days)
|
8 milligrams/kilogram (mg/kg) intravenously on Days 1 and 15 of each 28-ay cycle
Altri nomi:
80 milligram/square meter (mg/m2) intravenously Days 1, 8, and 15 of each 28 day cycle
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants With a Dose-Limiting Toxicity (DLT) During Cycle 1
Lasso di tempo: Cycle 1 of 28-day cycle
|
DLT based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE v4.02) in Cycle (Cy) 1 due to study drug (SD) with (w/): Grade (Gr) ≥3 neutropenia w/fever ≥38.5°C or w/bacteremia or sepsis, thrombocytopenia w/bleeding and platelet substitution, prothrombin and/or partial thromboplastin time w/no anticoagulation, hyperbilirubinemia; Gr 4: neutropenia >5 days, thrombocytopenia, Gr 4 or uncontrollable hypertension QTc>500 milliseconds (ms) or increase ≥100 ms increase in 24 hours after SD or significant arrhythmia in this period; Gr ≥3 nonhematologic toxicity (tox), excluding Gr 3 hypersensitivity, hypertension, injection-site reaction, arthralgia/myalgia, asthenia/fatigue, diarrhea w/out loperamide/nausea/vomiting w/out antiemetic and transient aminotransferase elevation.
SD tox=delay >1 week in ramucirumab (RAM) dose or omission of 1 dose of RAM or 2 paclitaxel doses due to tox in Cy 1 or delay >2 weeks between Cy 1 and Cy 2 due to persistent tox.
|
Cycle 1 of 28-day cycle
|
|
Number of Participants With Adverse Events (AEs)
Lasso di tempo: Up to 47 weeks post baseline
|
The number of participants who experienced AEs of any grade, AEs of Grade ≥3 or AEs resulting in death that were considered to be related to ramucirumab [RAM (IMC-1121B)] or paclitaxel (PAC).
A summary of serious adverse events (SAEs) and all other non-SAEs, regardless of causality, is located in the Reported Adverse Events module.
|
Up to 47 weeks post baseline
|
|
Number of Participants With Serious Adverse Events (SAEs)
Lasso di tempo: Up to 47 weeks post baseline
|
The number of participants who experienced SAEs that were considered to be related to ramucirumab [RAM (IMC-1121B)] or paclitaxel (PAC).
A summary of SAEs and all other non-SAEs, regardless of causality, is located in the Reported Adverse Events module.
|
Up to 47 weeks post baseline
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 1
Lasso di tempo: Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
|
Cmax after a single dose of ramucirumab (IMC-1121B).
|
Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
|
|
Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)
Lasso di tempo: Cycle 1 through Cycle 5 (28-day cycles)
|
The percentage of participants who were treatment-emergent positive for anti-ramucirumab (IMC-1121B) antibodies.
|
Cycle 1 through Cycle 5 (28-day cycles)
|
|
Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 1
Lasso di tempo: Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
|
AUC from time 0 to infinity (0-∞) after a single dose of ramucirumab (IMC-1121B).
|
Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
|
|
Ramucirumab Half-Life (t1/2) for Cycle 1
Lasso di tempo: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
|
Terminal t1/2 (the time it takes for the concentration of ramucirumab (IMC-1121B) in plasma or serum to decline by 50%) after a single dose of ramucirumab (IMC-1121B).
|
Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
|
|
Ramucirumab Clearance (CL) or Cycle 1
Lasso di tempo: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
|
CL [the volume of plasma or serum cleared of ramucirumab (IMC-1121B) per unit time] after a single dose of ramucirumab (IMC-1121B).
|
Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
|
|
Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 1
Lasso di tempo: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
|
Vss [distribution of ramucirumab (IMC-1121B) in the body at steady state] after a single dose of ramucirumab (IMC-1121B).
|
Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
|
|
Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 2
Lasso di tempo: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
|
Cmax after multiple doses of ramucirumab (IMC-1121B).
|
Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
|
|
Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 2
Lasso di tempo: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
|
AUC within the dosing interval (0-τ) after multiple doses of ramucirumab (IMC-1121B).
|
Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
|
|
Ramucirumab Half-Life (t1/2) for Cycle 2
Lasso di tempo: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
|
Terminal t1/2 [the time it takes for the concentration of ramucirumab (IMC-1121B) in plasma or serum to decline by 50%] after multiple doses of ramucirumab(IMC-1121B).
|
Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
|
|
Ramucirumab Clearance (CL) for Cycle 2
Lasso di tempo: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
|
CL [the volume of plasma or serum cleared of ramucirumab (IMC-1121B) per unit time] at steady state after multiple doses of ramucirumab (IMC-1121B).
|
Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
|
|
Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 2
Lasso di tempo: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
|
Vss [distribution of ramucirumab (IMC-1121B) in in the body at steady state] is not calculated for multiple doses of ramucirumab (IMC-1121B).
|
Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
|
|
Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 3
Lasso di tempo: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
|
Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) Cmax could not be calculated in Cycle 3.
|
Cycle 3: Pre-infusion, Day 1 of 28-day cycle
|
|
Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 3
Lasso di tempo: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
|
Due to the sparse pharmacokinetic sampling ramucirumab (IMC-1121B) AUC within the dosing interval (0-τ) could not be calculated in Cycle 3.
|
Cycle 3: Pre-infusion, Day 1 of 28-day cycle
|
|
Ramucirumab Half-Life (t 1/2) for Cycle 3
Lasso di tempo: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
|
Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) t1/2 could not be calculated in Cycle 3.
|
Cycle 3: Pre-infusion, Day 1 of 28-day cycle
|
|
Ramucirumab Clearance (CL) for Cycle 3
Lasso di tempo: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
|
Due to sparse pharmacokinetic sampling CL could not be calculated for ramucirumab (IMC-1121B) in Cycle 3.
|
Cycle 3: Pre-infusion, Day 1 of 28-day cycle
|
|
Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 3
Lasso di tempo: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
|
Due to sparse pharmacokinetic sampling Vss for ramucirumab (IMC-1121B) could not be calculated in Cycle 3.
|
Cycle 3: Pre-infusion, Day 1 of 28-day cycle
|
|
Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 4
Lasso di tempo: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
|
Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) Cmax could not be calculated in Cycle 4.
|
Cycle 4: Pre-infusion, Day 1 of 28-day cycle
|
|
Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 4
Lasso di tempo: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
|
Due to sparse pharmacokinetic sampling AUC within the dosing interval (0-τ) for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.
|
Cycle 4: Pre-infusion, Day 1 of 28-day cycle
|
|
Ramucirumab Half-Life (t 1/2) for Cycle 4
Lasso di tempo: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
|
Due to sparse pharmacokinetic sampling t1/2 for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.
|
Cycle 4: Pre-infusion, Day 1 of 28-day cycle
|
|
Ramucirumab Clearance (CL) for Cycle 4
Lasso di tempo: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
|
Due to sparse pharmacokinetic sampling CL for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.
|
Cycle 4: Pre-infusion, Day 1 of 28-day cycle
|
|
Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 4
Lasso di tempo: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
|
Due to sparse pharmacokinetic sampling Vss for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.
|
Cycle 4: Pre-infusion, Day 1 of 28-day cycle
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
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.
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 ottobre 2011
Completamento dello studio (Effettivo)
1 ottobre 2011
Date di iscrizione allo studio
Primo inviato
2 dicembre 2010
Primo inviato che soddisfa i criteri di controllo qualità
2 dicembre 2010
Primo Inserito (Stima)
3 dicembre 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
18 giugno 2014
Ultimo aggiornamento inviato che soddisfa i criteri QC
16 maggio 2014
Ultimo verificato
1 maggio 2014
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Neoplasie per tipo istologico
- Neoplasie
- Carcinoma
- Neoplasie, ghiandolari ed epiteliali
- Adenocarcinoma
- Meccanismi molecolari dell'azione farmacologica
- Agenti antineoplastici
- Modulatori della tubulina
- Agenti antimitotici
- Modulatori della mitosi
- Agenti antineoplastici, fitogenici
- Paclitaxel
- Ramucirumab
Altri numeri di identificazione dello studio
- 14204
- CP12-1026 (Altro identificatore: ImClone Systems)
- I4T-IE-JVBW (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 .