A Study of Ramucirumab and Docetaxel in Participants With Solid Tumors

Completed · Phase 2

Conditions studied: Malignant Solid Tumor

In brief

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.

Key facts

Study ID: NCT01567163
Run by: Eli Lilly and Company
People needed: 22
Starts: 2012-07-01
Expected to finish: 2014-03-01
Last updated by the study team: 2014-10-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

ImClone Investigational Site — Ann Arbor, Michigan, United States
ImClone Investigational Site — Detroit, Michigan, United States
ImClone Investigational Site — New Brunswick, New Jersey, United States
ImClone Investigational Site — Huntersville, North Carolina, United States
ImClone Investigational Site — Cleveland, Ohio, United States
ImClone Investigational Site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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