A Study in Participants With Advanced Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01682135
First received: September 6, 2012
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

This trial is testing ramucirumab (LY3009806) administered to Chinese participants with advanced solid tumors that are resistant to standard therapy or for whom no standard therapy is available. The purpose of this study is to evaluate how safe ramucirumab is and whether it causes any side effects. The study will also measure how much ramucirumab gets into the blood stream and how long it takes the body to get rid of it.


Condition Intervention Phase
Solid Tumor
Biological: Ramucirumab
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Ramucirumab in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of Participants with One or More Drug-Related Adverse Events (AEs) or Any Serious AEs [ Time Frame: Baseline through study completion (estimated as 32 months) ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics: Maximum Concentration (Cmax) and Minimum Concentration (Cmin) of Ramucirumab [ Time Frame: Baseline up to Cycle 5, Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area Under the Concentration Curve (AUC) of Ramucirumab [ Time Frame: Baseline up to Cycle 5, Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of Response [ Time Frame: Response to disease progression or death (estimated as 10 weeks) ] [ Designated as safety issue: No ]
  • Duration of Stable Disease [ Time Frame: Baseline to disease progression (estimated as 10 weeks) ] [ Designated as safety issue: No ]
  • Time to Disease Progression [ Time Frame: Baseline to disease progression (estimated as 10 weeks) ] [ Designated as safety issue: No ]
  • Number of Participants with Anti-Ramucirumab Antibodies [ Time Frame: Baseline up to Cycle 3, Day 1 ] [ Designated as safety issue: No ]
  • Percentage of Participants with Best Objective Response (BOR) [ Time Frame: Baseline to measured response (estimated as 10 weeks) ] [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: November 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ramucirumab
Ramucirumab administered intravenously (IV) at escalating doses (6 milligrams per kilogram [mg/kg] up to 10 mg/kg) every 2‐3 weeks for 6 weeks (1 Cycle). Treatment may continue until discontinuation criterion is met.
Biological: Ramucirumab
Administered IV.
Other Names:
  • IMC-1121B
  • LY3009806

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chinese participants with histopathologically or cytologically diagnosed advanced solid tumor
  • Did not respond to standard therapy or no standard therapy is available
  • Measurable or nonmeasurable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST)
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 at study entry
  • Able to provide written informed consent
  • A life expectancy of >3 months
  • Adequate hematologic function, as defined by: Absolute neutrophil count (ANC) ≥1500 per cubic millimeter (mm^3); hemoglobin concentration ≥9 grams per deciliter (g/dL); and platelet count ≥100,000/mm^3
  • Adequate hepatic function, as defined by: Total bilirubin level ≤1.5 x the upper limit of normal (ULN) (in participants with known Gilbert Syndrome, a total bilirubin ≤ 3.0 x ULN with direct bilirubin ≤ 1.5 x ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN (or ≤5 x ULN if the participant has liver metastases
  • Adequate renal function, as defined by: Serum creatinine level ≤1.5 x ULN; or calculated serum creatinine clearance (Cockcroft-Gault) ≥50 milliliters per minute (mL/min)
  • Urinary protein is 0 or 1+ on dipstick but no edema nor serum albumin < lower level of normal
  • Adequate coagulation function, as defined by: International normalized ratio (INR) ≤1.5, or prothrombin time (PT) ≤1.5 x ULN and activated partial thromboplastin time (aPTT) ≤1.5 x ULN (unless receiving anticoagulation therapy)
  • Agrees to use adequate contraception during the study period and for 12 weeks after the last dose of study treatment

Exclusion Criteria:

  • Had chemotherapy or therapeutic radiotherapy within 14 days (6 weeks for nitrosoureas or mitomycin C) before entering the study or the participant has ongoing side effects (≥ Grade 2) due to previously administered agents
  • Has obvious evidence of intratumor cavitation
  • Has undergone major surgery within 28 days before study entry or has had a central venous access device inserted within 7 days before study entry
  • Has a history of gastrointestinal perforation, postoperative bleeding complications, or wound complications from a surgical procedure
  • Has elective or planned surgery to be conducted during the trial
  • Has documented and/or symptomatic brain or leptomeningeal metastases
  • Has uncontrolled ongoing illness, for example: thrombotic or hemorrhagic disorders; hemoptysis; ongoing infection requiring systemic antibiotic treatment; congestive heart failure, angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months; stroke, transient ischemic attack (TIA), or other grade 3-4 arterial thromboembolic event occurring within 6 months; uncontrolled hypertension (≥150/≥90 millimeters of mercury [mmHg]); cardiac arrhythmia that requires treatment or asymptomatic sustained ventricular tachycardia; peripheral neuropathy ≥Grade 2; human immunodeficiency virus (HIV) or active, uncontrolled hepatitis, liver cirrhosis at a level of Child-Pugh Class B (or worse), liver cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. (Clinically meaningful ascites is defined as ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis)
  • Has a serious or nonhealing wound, ulcer, or bone fracture within 28 days before study entry
  • Has experienced any Grade 3 or 4 gastrointestinal bleeding within 3 months before study entry
  • Has a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess <6 months before randomization, or the participant has a history of poorly controlled or recurrent inflammatory bowel disease (including Crohn's disease or ulcerative colitis)
  • Has participated in a clinical study of a non-approved experimental agent or procedure within 4 weeks prior to study entry for small molecules, or 8 weeks before study entry for nonapproved monoclonal antibodies
  • Has a known allergy to ramucirumab or its excipients, a monoclonal antibody (MAb), or any other therapeutic protein, such as fresh frozen plasma, human serum albumin (HSA), cytokines, or interleukins. If there is suspicion that the participant may have an allergy, the participant should be excluded
  • Is pregnant (confirmed by urine or serum pregnancy test) or lactating
  • Has known alcohol or drug dependency
  • Is receiving chronic therapy with nonsteroidal anti-inflammatory agents (NSAIDs)
  • Is not considered to be suitable for this study, in the opinion of the investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01682135

Contacts
Contact: This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4559) 1-317-615-4559

Locations
China
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Shanghai, China, 200032
Contact: Eli Lilly         
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: NCT01682135     History of Changes
Other Study ID Numbers: 14139, I4T-CR-JVBU
Study First Received: September 6, 2012
Last Updated: March 17, 2014
Health Authority: China: Food and Drug Administration
United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 20, 2014