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A Phase 1b Study of Irinotecan, Levofolinate, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab (IMC-1121B) Drug Product in Japanese Subjects With Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy With Bevacizumab, Oxaliplatin, and a Fluoropyrimidine


Phase 1
20 Years
N/A
Not Enrolling
Both
Colorectal Carcinoma

Thank you

Trial Information

A Phase 1b Study of Irinotecan, Levofolinate, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab (IMC-1121B) Drug Product in Japanese Subjects With Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy With Bevacizumab, Oxaliplatin, and a Fluoropyrimidine


Inclusion Criteria:



- Participant is Japanese

- Has an ECOG performance status of 0 or 1

- Has histologically or cytologically confirmed CRC

- Has metastatic disease that is not amenable to potentially curative resection

- Has measurable or nonmeasurable disease based on the Response Evaluation Criteria in
Solid Tumors, Version 1.1 (RECIST v 1.1)

- Has received no more than 2 prior systemic chemotherapy regimens in any setting

- Has received first-line combination therapy of bevacizumab, oxaliplatin, and a
fluoropyrimidine for metastatic disease and has experienced disease progression
during first-line therapy, or disease progression within 6 months after the last dose
of first-line therapy

- Has adequate hepatic, renal, hematologic, and coagulation function

- Eligible participants of reproductive potential agree to use adequate contraceptive
methods during the study period and for 12 weeks after the study

Exclusion Criteria:

- Has received bevacizumab within 28 days prior to study registration

- Has received chemotherapy within 21 days prior to study registration

- Has received any previous systemic therapy (other than a combination of bevacizumab,
oxaliplatin, and a fluoropyrimidine) for first-line treatment of metastatic CRC

- Has received wide-field (full-dose pelvic) radiotherapy within 28 days prior to study
registration

- Has received any investigational therapy within 28 days prior to the study
registration date

- Has undergone major surgery within 28 days prior to study registration

- Has elective or planned surgery to be conducted during the trial.

- Has a history of deep vein thrombosis or pulmonary embolism within the past 12 months

- Has experienced any arterial thrombotic event within the past 12 months.

- Participant is receiving therapeutic anticoagulation with warfarin, low-molecular
weight heparin, or similar agents

- Participant is receiving chronic therapy with nonsteroidal anti-inflammatory agents

- Has a significant bleeding disorder or has had a significant (Grade 3 or higher)
bleeding event within 3 months prior to registration date

- Has a history of gastrointestinal perforation and/or fistulae within 6 months prior
to registration date

- Has symptomatic congestive heart failure, unstable angina pectoris, or symptomatic or
poorly controlled cardiac arrhythmia

- Has uncontrolled arterial hypertension

- Has a serious or nonhealing wound, peptic ulcer or bone fracture within 28 days prior
to study registration

- Has an acute/subacute bowel obstruction or history of chronic diarrhea

- Has a history of inflammatory bowel disease or Crohn's disease requiring medical
intervention within 12 months prior to registration date

- Has had prior organ transplantation

- Has an active infection requiring antibiotic, antifungal, or antiviral therapy

- Has HIV or AIDS

- Participant is pregnant or lactating

- Has brain metastases or uncontrolled spinal cord compression

- Has an uncontrolled metabolic disorder

- Has a known allergy or hypersensitivity to monoclonal antibody treatment or any
components used in ramucirumab DP preparation

- Has a known allergy or hypersensitivity to any of the study medication components or
other contraindication to receive the study medications

- Has a known history of Gilbert's Syndrome is known to have any of the following
genotypes: UGT1A1*6/*6; UGT1A1*28/*28 or UGT1A1*6/*28

- Has previous or concurrent malignancy, except for basal or squamous cell skin cancer
and/or in situ carcinoma, or other solid tumors treated curatively and without
evidence of recurrence for at least 3 years

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of participants that experience any Dose-Limiting Toxicities (DLT) during the the DLT assessment period

Outcome Time Frame:

Day 1, Cycle 1 through Day 1, Cycle 3

Safety Issue:

Yes

Principal Investigator

Email: Clinicaltrials@Imclone.com

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC

Authority:

Japan: Institutional Review Board

Study ID:

14223

NCT ID:

NCT01286818

Start Date:

February 2011

Completion Date:

March 2012

Related Keywords:

  • Colorectal Carcinoma
  • Colon Cancer
  • Rectal Cancer
  • Carcinoma
  • Colorectal Neoplasms

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