A Study to Assess the Pharmacokinetics of Ramucirumab (IMC-1121B) in Combination With FOLFIRI

Completed · Phase 2

Conditions studied: Solid Tumors

In brief

The purpose of this study is to assess the effect of concomitant ramucirumab (IMC-1121B) on the pharmacokinetics of irinotecan and its metabolite SN-38 when coadministered with folinic acid and 5-fluorouracil, in participants with advanced malignant solid tumors resistant to standard therapy or for which no standard therapy is available.

Key facts

Study ID: NCT01634555
Run by: Eli Lilly and Company
People needed: 29
Starts: 2012-10-01
Expected to finish: 2018-02-01
Last updated by the study team: 2019-02-26

Who can join

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

You may qualify if…

Has histologic or cytologic documentation of a malignant solid tumor
Has an advanced solid tumor that is resistant to standard therapy or for which no standard therapy is available
Has resolution to Grade ≤1, per 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
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Has adequate hematologic, coagulation, and hepatic function
Has serum creatinine ≤ 1.5 x upper limit of normal (ULN)
Urinary protein is <2+ on dipstick or routine urinalysis (UA) at study entry
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 received a therapeutic monoclonal antibody within the last 42 days
Has received cytotoxic chemotherapy within the last 21 days
Has received radiotherapy within the last 14 days
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 a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism during the last 3 months
Has an uncontrolled illness, including, but not limited to uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders
Has experienced any arterial thromboembolic event within the last 6 months
Has known leptomeningeal disease or brain metastases or uncontrolled spinal cord compression
Has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy
Has known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness
Has received a prior organ or transplantation
Has undergone major surgery within the last 28 days
Has had a serious nonhealing wound, ulcer, or bone fracture within the last 28 days
Has an elective or planned major surgery to be performed during the course of the trial
Has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection, Crohn's disease, ulcerative colitis, or chronic diarrhea
Has experienced a Grade 3 or higher bleeding event within the last 3 months
Has a known history or clinical evidence of Gilbert's Syndrome, or is known to have any of the following genotypes: uridine diphosphate glucuronosyltransferase isoform 1A1 (UGT1A1)*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28
Has received clinically relevant inhibitors or inducers of cytochrome P (CYP) 450 CYP3A4/5 or CYP2C9 and/or isoenzymes within the last 3 weeks
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

Where it is running

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician — Detroit, Michigan, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician — Las Vegas, Nevada, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician — Cleveland, Ohio, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician — Philadelphia, Pennsylvania, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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