Study of IMC-1121B in Patients With Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Intervention: IMC-1121B
Intervention description: Cycle 1: Upon completion of enrollment criteria confirmed at screening, the first dose of study medication should be administered within 7 days. The infusion will be planned every 2 weeks or every 3 weeks on the same day of the week of the first infusion. Dose escalation to Cohort 2 may occur in the absence of a dose-limiting toxicity (DLT) in the first three participants treated in Cohort 1 during the initial 6-week dosing period (Cycle 1). The same procedure will be followed for dose escalation from Cohort 2 to Cohort 3. If 1 of 3 participants in any cohort experiences a DLT in the first 6 weeks (Cycle 1), 3 additional participants will be enrolled in that cohort. Dose escalation to the next cohort may occur if less that 2 of 6 participants experience a DLT during Cycle 1.
Intervention MeSH terms: Ramucirumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Solid tumor; recombinant human IgG1; MAB; monoclonal antibody; VEGFR 2; human vascular endothelial growth factor receptor 2

Summary:

      This trial is testing the investigational drug IMC-1121B administered to Japanese
      participants with advanced solid tumors who have not responded to standard therapy or for
      whom no standard therapy is available. The rationale for performing this trial is to
      establish the safety profile and the pharmacokinetics of IMC-1121B.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Solid tumor participant who was been histopathologically or cytologically documented.

          -  Advanced primary or recurrent solid tumors participant who has not responded to
             standard therapy or no standard therapy is available.

          -  The participant has measurable or nonmeasurable lesions according to Response
             Evaluation Criteria in Solid Tumors (RECIST).

          -  The participant has an Eastern Cooperative Oncology Group (ECOG) performance status
             (PS) score of 0-1 at study entry.

          -  The participant is able to provide written informed consent.

          -  The participant is age 20 years or older.

          -  The participant has a life expectancy of > 3 months.

          -  The participant has adequate hematologic function, as defined by:

          -  An absolute neutrophil count (ANC) > 1500/cubic millimeter (mm³) or /microliter (µL)

          -  A hemoglobin level > 10 grams/deciliter (g/dL)

          -  A platelet count > 100,000/mm³ or /µL

          -  The participant has adequate hepatic function, as defined by:

          -  A total bilirubin level < 1.8 milligrams/deciliter (mg/dL)

          -  Aspartate transaminase (AST) levels < 86 International Units/liter (IU/L)

          -  Alanine transaminase (ALT) levels ≤ 86 IU/L

          -  The participant has adequate renal function, as defined by:

          -  Serum creatinine level ≤ 1.5 mg/dL, or

          -  Calculated serum creatinine clearance (Cockcroft-Gault) ≥ 60 milliliters/minute
             (mL/min)

          -  The participant's urinary protein is 0 on dipstick or 1+ but participant does not have
             edema nor serum albumin < lower level of normal (LLN).

          -  The participant has adequate coagulation function, as defined by international
             normalized ratio (INR) ≤ 1.5.

          -  The participant agrees to use adequate contraception during the study period and for
             12 weeks after the last dose of study treatment.

        Exclusion Criteria:

          -  The participant has had chemotherapy or therapeutic radiotherapy within 28 days (6
             weeks for nitrosoureas or mitomycin C) prior to entering the study or participant has
             ongoing side effects ≥ Grade 2 due to agents administered more than 28 days earlier.

          -  The participant has obvious evidence of intratumor cavitation.

          -  The participant has undergone major surgery (example, laparotomy, thoracotomy, removal
             of organ[s]) within 28 days prior to study entry, or subcutaneous venous access device
             placement within 7 days prior to study entry.

          -  The participant has a history of postoperative bleeding complications or wound
             complications from a surgical procedure.

          -  The participant has elective or planned surgery to be conducted during the trial.

          -  The participant has documented and/or symptomatic brain or leptomeningeal metastases.
             (Participants who are clinically stable [no symptoms during 4 weeks prior to the
             enrollment] with an assessment that no further treatment [radiation, surgical
             excision, and administration of steroids] is required, are permitted to enter the
             study.)

          -  The participant has uncontrolled intercurrent illness including, but not limited to:

          -  Thrombotic or hemorrhagic disorders

          -  Hemoptysis (approximately one-half of a teaspoon)

          -  Ongoing or active infection requiring systemic antibiotic treatment

          -  Congestive heart failure (Class III or IV of the New York Heart Association
             classification for heart disease)

          -  Angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months

          -  Uncontrolled hypertension (systolic blood pressure > 150 millimeters of mercury
             (mmHg), diastolic blood pressure > 95 mm Hg)

          -  Cardiac arrhythmia requires treatment [National Cancer Institute Common Terminology
             Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v 3.0), Grade 3], or asymptomatic
             sustained ventricular tachycardia)

          -  Peripheral neuropathy of any etiology ≥ Grade 2 (NCI-CTCAE v 3.0)

          -  The participant has participated in clinical studies of non-approved experimental
             agents or procedures within 4 weeks prior to study entry for small molecules, or 8
             weeks prior to study entry for non-approved monoclonal antibodies.

          -  The participant, if female, is pregnant (confirmed by urine or serum pregnancy test)
             or lactating.