A Study of Ramucirumab and Docetaxel in Participants With Solid Tumors
Condition: Malignant Solid Tumor
MeSH terms: Neoplasms
Intervention: Ramucirumab; Docetaxel
Intervention description: ramucirumab 10 milligrams/kilogram (mg/kg) intravenous infusion, administered on Day 1 of 3-week cycle; docetaxel 75 milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of each 3-week cycle
Intervention MeSH terms: Docetaxel; Ramucirumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Malignant Solid Tumors

Summary:

      The purpose of this study is to assess the effect of concomitant ramucirumab on the
      pharmacokinetics of docetaxel in participants with advanced malignant solid tumors.

      Participants who do not complete both Cycle 1, Day 1, and Cycle 2, Day 1 according to
      schedule will be replaced for the purpose of analysis; these participants may continue to
      receive study therapy. No dose reductions, delayed or missed doses are allowed during Cycles
      1 and 2.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has histologic or cytologic documentation of a malignant solid tumor

          -  Participant has an advanced solid tumor that is resistant to standard therapy or for
             which no standard therapy is available

          -  Participant has had 0-1 prior taxane-containing treatment regimens (including taxane
             monotherapy), which must have been completed at least 6 months before the first dose
             of study medication. Prior bevacizumab is allowed.

          -  Participant has resolution to Grade ≤ 1 (except where otherwise stated in this
             eligibility criteria) by the National Cancer Institute Common Terminology Criteria for
             Adverse Events, Version 4.0 (NCI-CTCAE v 4.0) of all clinically significant toxic
             effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy

          -  Participant has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of
             0-2

          -  Participant has adequate hematologic function (absolute neutrophil count [ANC] ≥ 1500
             cells/liter (cells/L), hemoglobin ≥ 10 grams/deciliter (g/dL), and platelet count ≥
             100,000 cells/microliter (cells/mcL)]. Blood transfusion is allowed but must be
             completed 48 hours before study drug administration.

          -  Participant has adequate hepatic function (bilirubin ≤ 1.5 times the upper limit of
             normal [x ULN], aspartate transaminase [AST] and alanine transaminase [ALT] ≤ 1.5 x
             ULN)

          -  Participant has serum creatinine ≤ 1.5 x ULN. If serum creatinine > 1.5 x ULN, the
             calculated creatinine clearance [CrCl] should be ≥ 40 milliliters/minute (mL/min)

          -  Participant's urinary protein is <2+ on dipstick or routine urinalysis (UA) at study
             entry

          -  Participant must have adequate coagulation function as defined by an international
             normalized ratio (INR) of ≤ 1.5 and a partial thromboplastin time (PTT) or an
             activated PTT (aPTT) ≤ 1.5 x ULN

          -  Women with childbearing potential must have a negative serum or urine pregnancy test.
             Eligible participants of reproductive potential (both sexes) agree to use adequate
             method of contraception during the study period and for 12 weeks after the last dose
             of study medication.

        Exclusion Criteria:

          -  Has a known allergy or hypersensitivity to any of the treatment components

          -  Are currently enrolled in, or discontinued within the last 14 days from, a clinical
             trial involving an investigational product or non-approved use of a drug or device, or
             concurrently enrolled in any other type of medical research judged not to be
             scientifically or medically compatible with this study

          -  Has received a therapeutic monoclonal antibody within 42 days prior to first dose of
             study medication

          -  Has received radiotherapy within 14 days prior to first dose of study medication

          -  Has received cytotoxic chemotherapy within 21 days prior to first dose of study
             medication

          -  Is receiving concurrent treatment with another anticancer therapy, including
             chemotherapy, immunotherapy, hormonal therapy (except for androgen deprivation therapy
             for prostate cancer), radiation therapy, chemoembolization, targeted or other
             investigational anticancer therapy

          -  Is receiving chronic therapy with nonsteroidal anti-inflammatory agents or other
             antiplatelet agents. (Aspirin use at doses up to 325 milligrams/day (mg/day) and
             analgesic agents with no or low bleeding risk are permitted.)

          -  Has a history of uncontrolled hereditary or acquired bleeding or thromboembolic
             disorders

          -  Has experienced any arterial thromboembolic event, including myocardial infarction
             (MI), unstable angina, stroke or transient ischemic attack (TIA), within 6 months
             prior to first dose of study medication

          -  Has a history of deep vein thrombosis, pulmonary embolism, or any other significant
             thromboembolism during the 3 months prior to first dose of study medication

          -  Has experienced a Grade 3 or 4 hemorrhagic event within 3 months prior to first dose
             of study medication

          -  Has experienced peripheral neuropathy ≥ Grade 2 at any time prior to study entry

          -  Has a bowel obstruction, history or presence of inflammatory enteropathy or extensive
             intestinal resection, Crohn's disease, ulcerative colitis, or chronic diarrhea

          -  History of gastrointestinal perforation and/or fistulae within 6 months prior to
             randomization

          -  Has an ongoing or active infection requiring treatment with intravenous antibiotics

          -  Has a serious or nonhealing wound, peptic ulcer, or bone fracture within 28 days prior
             to first dose of study medication

          -  Has uncontrolled hypertension despite standard medical management

          -  Has symptomatic congestive heart failure, symptomatic or poorly controlled cardiac
             arrhythmia, or any other serious, uncontrolled medical disorders, which in the opinion
             of the investigator would make the participant ineligible for participation in the
             study

          -  Has known brain or leptomeningeal metastases

          -  Has known positive status for human immunodeficiency virus (HIV) infection or acquired
             immunodeficiency syndrome-related illness

          -  Has known active drug or alcohol abuse

          -  Has pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring
             active treatment, including the use of oxygen

          -  Has had major surgery within 28 days prior to first dose of study medication or
             subcutaneous venous access device implantation within 7 days prior to first dose of
             study medication

          -  Has an elective or planned major surgery during the course of the trial

          -  If the primary cancer is non-small-cell lung cancer (NSCLC), there is radiographic
             evidence of intratumor cavitation, major blood vessel invasion or encasement by
             cancer, or proximity of cancer to major airways

          -  Has received prior ramucirumab (IMC-1121B) therapy

          -  Is receiving concomitant therapy with clinically relevant inhibitors or inducers of
             cytochrome P450 3A4 and 3A5 and/or isoenzymes

          -  Has cirrhosis at a level of Child-Pugh B (or worse), or cirrhosis and a history of
             hepatic encephalopathy, or ascites resulting from cirrhosis and requiring ongoing
             treatment with diuretics and/or paracentesis