Study of Weekly Paclitaxel With Ramucirumab in Participan... | NCT01253525

NCT01253525

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
CP12-1026	Other Identifier	ImClone Systems
I4T-IE-JVBW	Other Identifier	Eli Lilly and Company

Status Module

Label	Type	Description	Intervention Names
Ramucirumab (IMC-1121B ) and Pacitaxel	Experimental	Each treatment cycle is 4 weeks (28 days)	Biological: Ramucirumab (IMC-1121B ) Drug: Paclitaxel

Name	Type	Description	Arm Group Labels	Other Names
Ramucirumab (IMC-1121B )	Biological	8 milligrams/kilogram (mg/kg) intravenously on Days 1 and 15 of each 28-ay cycle	Ramucirumab (IMC-1121B ) and Pacitaxel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With a Dose-Limiting Toxicity (DLT) During Cycle 1	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)	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)	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

Secondary Outcomes

Measure	Description	Time Frame
Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 1	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)

Eligibility Module

Eligibility Criteria

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

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
ImClone Investigational Site		Chiba		277-8577	Japan
ImClone Investigational Site

PubMed Identifier	Type	Citation	Retractions
25888272	Derived	Ueda S, Satoh T, Gotoh M, Gao L, Doi T. A phase ib study of safety and pharmacokinetics of ramucirumab in combination with paclitaxel in patients with advanced gastric adenocarcinomas. Oncologist. 2015 May;20(5):493-4. doi: 10.1634/theoncologist.2014-0440. Epub 2015 Apr 17.

ID	Title	Description
FG000	Ramucirumab + Paclitaxel	Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle. Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Ramucirumab + Paclitaxel	Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle. Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type	Title	Description	Population Description	Reporting Status	Anticipated Posting Date	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Time Frame	Units Analyzed	Denominator Units Selected	Arm/Group Information	Denominators	Classes	Analyses
Primary	Number of Participants With a Dose-Limiting Toxicity (DLT) During Cycle 1	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.	All enrolled participants who complete the first cycle of study drug or discontinued study drug due to a DLT during Cycle 1.	Posted		Number		participants		Cycle 1 of 28-day cycle

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ramucirumab + Paclitaxel	Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle. Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle.

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins