- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01253525
Study of Weekly Paclitaxel With Ramucirumab in Participants With Advanced Gastric Adenocarcinomas
16. mai 2014 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
6
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Chiba, Japan, 277-8577
- ImClone Investigational Site
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Osaka, Japan, 569-8686
- ImClone Investigational Site
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Osaka, Japan, 589-5811
- ImClone Investigational Site
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Ramucirumab (IMC-1121B ) and Pacitaxel
Each treatment cycle is 4 weeks (28 days)
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8 milligrams/kilogram (mg/kg) intravenously on Days 1 and 15 of each 28-ay cycle
Andre navn:
80 milligram/square meter (mg/m2) intravenously Days 1, 8, and 15 of each 28 day cycle
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants With a Dose-Limiting Toxicity (DLT) During Cycle 1
Tidsramme: Cycle 1 of 28-day cycle
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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.
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Cycle 1 of 28-day cycle
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Number of Participants With Adverse Events (AEs)
Tidsramme: Up to 47 weeks post baseline
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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.
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Up to 47 weeks post baseline
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Number of Participants With Serious Adverse Events (SAEs)
Tidsramme: Up to 47 weeks post baseline
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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.
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Up to 47 weeks post baseline
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 1
Tidsramme: Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Cmax after a single dose of ramucirumab (IMC-1121B).
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Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)
Tidsramme: Cycle 1 through Cycle 5 (28-day cycles)
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The percentage of participants who were treatment-emergent positive for anti-ramucirumab (IMC-1121B) antibodies.
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Cycle 1 through Cycle 5 (28-day cycles)
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Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 1
Tidsramme: Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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AUC from time 0 to infinity (0-∞) after a single dose of ramucirumab (IMC-1121B).
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Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Ramucirumab Half-Life (t1/2) for Cycle 1
Tidsramme: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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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).
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Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Ramucirumab Clearance (CL) or Cycle 1
Tidsramme: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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CL [the volume of plasma or serum cleared of ramucirumab (IMC-1121B) per unit time] after a single dose of ramucirumab (IMC-1121B).
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Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 1
Tidsramme: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Vss [distribution of ramucirumab (IMC-1121B) in the body at steady state] after a single dose of ramucirumab (IMC-1121B).
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Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 2
Tidsramme: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Cmax after multiple doses of ramucirumab (IMC-1121B).
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Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 2
Tidsramme: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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AUC within the dosing interval (0-τ) after multiple doses of ramucirumab (IMC-1121B).
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Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Ramucirumab Half-Life (t1/2) for Cycle 2
Tidsramme: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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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).
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Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Ramucirumab Clearance (CL) for Cycle 2
Tidsramme: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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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).
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Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 2
Tidsramme: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Vss [distribution of ramucirumab (IMC-1121B) in in the body at steady state] is not calculated for multiple doses of ramucirumab (IMC-1121B).
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Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 3
Tidsramme: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) Cmax could not be calculated in Cycle 3.
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Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 3
Tidsramme: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Due to the sparse pharmacokinetic sampling ramucirumab (IMC-1121B) AUC within the dosing interval (0-τ) could not be calculated in Cycle 3.
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Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Ramucirumab Half-Life (t 1/2) for Cycle 3
Tidsramme: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) t1/2 could not be calculated in Cycle 3.
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Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Ramucirumab Clearance (CL) for Cycle 3
Tidsramme: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Due to sparse pharmacokinetic sampling CL could not be calculated for ramucirumab (IMC-1121B) in Cycle 3.
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Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 3
Tidsramme: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Due to sparse pharmacokinetic sampling Vss for ramucirumab (IMC-1121B) could not be calculated in Cycle 3.
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Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 4
Tidsramme: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
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Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) Cmax could not be calculated in Cycle 4.
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Cycle 4: Pre-infusion, Day 1 of 28-day cycle
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Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 4
Tidsramme: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
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Due to sparse pharmacokinetic sampling AUC within the dosing interval (0-τ) for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.
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Cycle 4: Pre-infusion, Day 1 of 28-day cycle
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Ramucirumab Half-Life (t 1/2) for Cycle 4
Tidsramme: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
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Due to sparse pharmacokinetic sampling t1/2 for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.
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Cycle 4: Pre-infusion, Day 1 of 28-day cycle
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Ramucirumab Clearance (CL) for Cycle 4
Tidsramme: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
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Due to sparse pharmacokinetic sampling CL for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.
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Cycle 4: Pre-infusion, Day 1 of 28-day cycle
|
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Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 4
Tidsramme: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
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Due to sparse pharmacokinetic sampling Vss for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.
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Cycle 4: Pre-infusion, Day 1 of 28-day cycle
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2010
Primær fullføring (Faktiske)
1. oktober 2011
Studiet fullført (Faktiske)
1. oktober 2011
Datoer for studieregistrering
Først innsendt
2. desember 2010
Først innsendt som oppfylte QC-kriteriene
2. desember 2010
Først lagt ut (Anslag)
3. desember 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
18. juni 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. mai 2014
Sist bekreftet
1. mai 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 14204
- CP12-1026 (Annen identifikator: ImClone Systems)
- I4T-IE-JVBW (Annen identifikator: Eli Lilly and Company)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .