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Phase I Study of Ramucirumab in Patients With Advanced Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Solid Tumor

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Trial Information

Phase I Study of Ramucirumab in Patients With Advanced Solid Tumors

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

- 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

- Adequate renal function, as defined by: Serum creatinine level ≤1.5 x ULN; or
calculated serum creatinine clearance (Cockcroft-Gault) ≥50 milliliters per minute

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants with One or More Drug-Related Adverse Events (AEs) or Any Serious AEs

Outcome Time Frame:

Baseline through study completion (estimated as 32 months)

Safety Issue:


Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company


China: Food and Drug Administration

Study ID:




Start Date:

November 2012

Completion Date:

May 2016

Related Keywords:

  • Solid Tumor
  • Neoplasms