Skip to main content
OpenTrials
Completed

NCT Number: NCT01253525

Study of Weekly Paclitaxel With Ramucirumab in Participants With Advanced Gastric Adenocarcinomas

Investigate the safety and tolerability of ramucirumab (IMC-1121B) drug product (DP) in combination with paclitaxel.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adenocarcinoma Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ImClone Investigational Site, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ramucirumab (IMC-1121B )

Biological

8 milligrams/kilogram (mg/kg) intravenously on Days 1 and 15 of each 28-ay cycle

Other names: LY3009806, IMC-1121B

paclitaxel

Drug

80 milligram/square meter (mg/m2) intravenously Days 1, 8, and 15 of each 28 day cycle

Primary outcomes

  1. Number of Participants With a Dose-Limiting Toxicity (DLT) During Cycle 1

    Time frame: 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.

  2. Number of Participants With Adverse Events (AEs)

    Time frame: 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.

  3. Number of Participants With Serious Adverse Events (SAEs)

    Time frame: 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.

Secondary outcomes

  1. Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 1

    Time frame: 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).

  2. Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)

    Time frame: Cycle 1 through Cycle 5 (28-day cycles)

    The percentage of participants who were treatment-emergent positive for anti-ramucirumab (IMC-1121B) antibodies.

  3. Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 1

    Time frame: 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).

  4. Ramucirumab Half-Life (t1/2) for Cycle 1

    Time frame: 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).

  5. Ramucirumab Clearance (CL) or Cycle 1

    Time frame: 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).

  6. Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 1

    Time frame: 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).

  7. Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 2

    Time frame: 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).

  8. Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 2

    Time frame: 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).

  9. Ramucirumab Half-Life (t1/2) for Cycle 2

    Time frame: 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).

  10. Ramucirumab Clearance (CL) for Cycle 2

    Time frame: 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).

  11. Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 2

    Time frame: 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).

  12. Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 3

    Time frame: 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.

  13. Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 3

    Time frame: 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.

  14. Ramucirumab Half-Life (t 1/2) for Cycle 3

    Time frame: 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.

  15. Ramucirumab Clearance (CL) for Cycle 3

    Time frame: 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.

  16. Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 3

    Time frame: 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.

  17. Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 4

    Time frame: 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.

  18. Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 4

    Time frame: 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.

  19. Ramucirumab Half-Life (t 1/2) for Cycle 4

    Time frame: 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.

  20. Ramucirumab Clearance (CL) for Cycle 4

    Time frame: 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.

  21. Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 4

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 1b Study of Weekly Paclitaxel With Ramucirumab (IMC-1121B) Drug Product in Patients With Advanced Gastric Adenocarcinomas

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 3, 2010
Registry last updated
Jun 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.