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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01253525
First received: December 2, 2010
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Adenocarcinoma
Biological: Ramucirumab DP (IMC-1121B)
Drug: Paclitaxel
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1b Study of Weekly Paclitaxel With Ramucirumab (IMC-1121B) Drug Product in Patients With Advanced Gastric Adenocarcinomas

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of Participants with a Dose-Limiting Toxicity (DLT) during Cycle 1 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: 5 Months ] [ Designated as safety issue: Yes ]
  • Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: 5 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maximum concentration (Cmax) [ Time Frame: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 (Weeks 1, 2, and 3) ] [ Designated as safety issue: No ]
  • Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity) [ Time Frame: 5 Months ] [ Designated as safety issue: No ]
  • Area Under the Concentration (AUC) [ Time Frame: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 (Weeks 1, 2, and 3) ] [ Designated as safety issue: No ]
  • Half-life (t 1/2) [ Time Frame: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 (Weeks 1, 2, and 3) ] [ Designated as safety issue: No ]
  • Clearance (CL) [ Time Frame: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 (Weeks 1, 2, and 3) ] [ Designated as safety issue: No ]
  • Steady State Volume of distribution (Vss) [ Time Frame: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 (Weeks 1, 2, and 3) ] [ Designated as safety issue: No ]
  • Maximum concentration (Cmax) [ Time Frame: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 (Weeks 5, 6, and 7) ] [ Designated as safety issue: No ]
  • Area Under the Concentration (AUC) [ Time Frame: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 (Weeks 5, 6, and 7) ] [ Designated as safety issue: No ]
  • Half-life (t 1/2) [ Time Frame: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 (Weeks 5, 6, and 7) ] [ Designated as safety issue: No ]
  • Clearance (CL) [ Time Frame: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 (Weeks 5, 6, and 7) ] [ Designated as safety issue: No ]
  • Steady State Volume of distribution (Vss) [ Time Frame: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 (Weeks 5, 6, and 7) ] [ Designated as safety issue: No ]
  • Maximum concentration (Cmax) [ Time Frame: Cycle 3: Pre-infusion, Day 1 (Week 9) ] [ Designated as safety issue: No ]
  • Area Under the Concentration (AUC) [ Time Frame: Cycle 3: Pre-infusion, Day 1 (Week 9) ] [ Designated as safety issue: No ]
  • Half-life (t 1/2) [ Time Frame: Cycle 3: Pre-infusion, Day 1 (Week 9) ] [ Designated as safety issue: No ]
  • Clearance (CL) [ Time Frame: Cycle 3: Pre-infusion, Day 1 (Week 9) ] [ Designated as safety issue: No ]
  • Steady State Volume of distribution (Vss) [ Time Frame: Cycle 3: Pre-infusion, Day 1 (Week 9) ] [ Designated as safety issue: No ]
  • Maximum concentration (Cmax) [ Time Frame: Cycle 4: Pre-infusion, Day 1 (Week 13) ] [ Designated as safety issue: No ]
  • Area Under the Concentration (AUC) [ Time Frame: Cycle 4: Pre-infusion, Day 1 (Week 13) ] [ Designated as safety issue: No ]
  • Half-life (t 1/2) [ Time Frame: Cycle 4: Pre-infusion, Day 1 (Week 13) ] [ Designated as safety issue: No ]
  • Clearance (CL) [ Time Frame: Cycle 4: Pre-infusion, Day 1 (Week 13) ] [ Designated as safety issue: No ]
  • Steady State Volume of distribution (Vss) [ Time Frame: Cycle 4: Pre-infusion, Day 1 (Week 13) ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: December 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ramucirumab Drug Product (DP) and Paxlitaxel
Each treatment cycle is 4 weeks (28 days)
Biological: Ramucirumab DP (IMC-1121B)
8 mg/kg I.V. Days 1 and 15 of each 28 day cycle
Other Name: IMC-1121B
Drug: Paclitaxel
80 mg/m2 I.V. Days 1, 8, and 15 of each 28 day cycle

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has a histopathologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction 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 patients 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. (Patients receiving prophylactic, low-dose anticoagulation therapy are eligible provided that the coagulation parameters INR ≤ 1.5, PT and PTT or - Is receiving chronic therapy with nonsteroidal anti-inflammatory agents(Aspirin use at doses up to 325 mg/day is permitted.)
  • Has significant bleeding disorders, vasculitis, history of postoperative bleeding complications, hemoptysis or had a significant bleeding episode from the 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01253525

Locations
Japan
ImClone Investigational Site
Chiba, Japan, 277-8577
ImClone Investigational Site
Osaka, Japan, 589-5811
ImClone Investigational Site
Osaka, Japan, 569-8686
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01253525     History of Changes
Other Study ID Numbers: 14204, CP12-1026, I4T-IE-JVBW
Study First Received: December 2, 2010
Last Updated: August 19, 2013
Health Authority: Japan: Institutional Review Board

Keywords provided by Eli Lilly and Company:
Adenocarcinoma
Gastroesophageal Junction

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014