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A Study to Evaluate the Potential of Concomitant Ramucirumab to Affect the Pharmacokinetics of Irinotecan and Its Metabolite SN-38 When Coadministered With Folinic Acid and 5 Fluorouracil in Patients With Advanced Malignant Solid Tumors


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Solid Tumors

Thank you

Trial Information

A Study to Evaluate the Potential of Concomitant Ramucirumab to Affect the Pharmacokinetics of Irinotecan and Its Metabolite SN-38 When Coadministered With Folinic Acid and 5 Fluorouracil in Patients With Advanced Malignant Solid Tumors


Inclusion Criteria:



- 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 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 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 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: UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28

- Has received clinically relevant inhibitors or inducers of cytochrome P450 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Pharmacokinetics: Plasma concentrations of irinotecan and its metabolite SN-28

Outcome Time Frame:

Cycle 1 and Cycle 2: -0, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 22, 25, 28, 31, 34, 48, 72, 96 and 168 hours post irinotecan infusion

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC

Authority:

United States: Food and Drug Administration

Study ID:

14433

NCT ID:

NCT01634555

Start Date:

October 2012

Completion Date:

October 2013

Related Keywords:

  • Solid Tumors
  • Advanced Malignant Solid Tumors
  • Neoplasms

Name

Location

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.Kalamazoo, Michigan  49048
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  89169
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.Cincinnati, Ohio  45267
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.Dunmore, Pennsylvania  18512