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A Study to Evaluate the Potential of Concomitant Ramucirumab to Affect the Pharmacokinetics of Docetaxel in Patients With Advanced Malignant Solid Tumors

Phase 2
18 Years
Open (Enrolling)
Malignant Solid Tumor

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Trial Information

A Study to Evaluate the Potential of Concomitant Ramucirumab to Affect the Pharmacokinetics of Docetaxel in Patients With Advanced Malignant Solid Tumors

Inclusion Criteria:

- Patient has histologic or cytologic documentation of a malignant solid tumor

- Patient has an advanced solid tumor that is resistant to standard therapy or for
which no standard therapy is available

- Patient 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

- Patient 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

- Patient has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 -

- Patient has adequate hematologic function (absolute neutrophil count [ANC] ≥ 1500
cells/L, hemoglobin ≥ 10 g/dL, and platelet count ≥ 100,000 cells/uL) Blood
transfusion is allowed but must be completed 48 hours before study drug

- Patient 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

- Patient has serum creatinine ≤ 1.5 x ULN. If serum creatinine > 1.5 x ULN, the
calculated creatinine clearance [CrCl] should be ≥ 40 mL/min

- Patient's urinary protein is <2+ on dipstick or routine urinalysis (UA) at study

- Patient 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 patients 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

- 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 mg/day and analgesic agents with
no or low bleeding risk are permitted.)

- Has a history of uncontrolled hereditary or acquired bleeding or thromboembolic

- 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

- 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 patient 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

Type of Study:


Study Design:

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

Outcome Measure:

Pharmacokinetics: area under the concentration versus time curve (AUC) of docetaxel

Outcome Time Frame:

Cycle 1: 0, 1, 1.5, 2, 3, 5, 7, 24, 48, 72 hours post docetaxel infusion

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC


United States: Food and Drug Administration

Study ID:




Start Date:

July 2012

Completion Date:

July 2013

Related Keywords:

  • Malignant Solid Tumor
  • Advanced Malignant Solid Tumors
  • Neoplasms



ImClone Investigational Site Ypsilanti, Michigan  48198
ImClone Investigational Site Voorhees, New Jersey  08043
ImClone Investigational Site Cleveland, Ohio  44134
ImClone Investigational Site Winston-Salem, North Carolina  27103
ImClone Investigational Site Seattle, Washington  98104