A Study of Ramucirumab or Icrucumab in Colorectal Cancer

NCT01111604 | Completed Phase 2 Results DMC

• 3 other identifiers: 13942CP20-0801I4Y-IE-JCDB
• Study Type: interventional
• Target: 158
• Locations: 2 countries
• Sites: 17

Brief Summary

The purpose of this study is to determine if participants with metastatic colorectal cancer live longer without their cancer progressing when treated with standard chemotherapy, standard chemotherapy plus ramucirumab, or standard chemotherapy plus icrucumab.

Conditions

Colon Cancer; Rectal Cancer

Keywords

Colonic Neoplasms; Rectal Neoplasms; Adenocarcinoma; Antibodies, Monoclonal

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS is defined as the time from baseline until the date of disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or death from any cause, whichever was first. Participants who die without a reported prior progression will be considered to have progressed on the day of their death. Participants who did not progress, are lost to follow-up, or have missed two or more scheduled tumor assessments will be censored at the day of their last radiographic tumor assessment, if there are no post-baseline tumor measurements for a randomized and treated participant, the participant will be censored at the date of randomization. If death or progressive disease (PD) occurs after 2 or more missing radiographic visits, censoring will occur at the date of the last radiographic visit prior to the last visit.

  Baseline until Disease Progression or Death from Any Cause (Up to 95 Weeks)

Secondary Outcomes (14)

• Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])

  Baseline until Disease Progression (Up to 95 Weeks)

• Overall Survival (OS)

  Baseline Until Death from Any Cause (Up to 163 Weeks)

• Duration of Response (DoR)

  Criteria First Met for CR or PR until Disease Progression or Death from Any Cause (Up to 95 Weeks)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) at Cycle 5

  Cycle 5, 1 Hour Post End of Infusion

• Pharmacokinetics (PK): Trough Serum Concentrations (Ctrough) at Cycle 5

  Cycle 5, Prior to Infusion

Study Arms (3)

mFOLFOX-6

ACTIVE COMPARATOR

mFOLFOX-6

Drug: mFOLFOX-6

mFOLFOX-6 + Ramucirumab

EXPERIMENTAL

mFOLFOX-6 + Ramucirumab

Biological: Ramucirumab; Drug: mFOLFOX-6

mFOLFOX-6 + Icrucumab

EXPERIMENTAL

mFOLFOX-6 + Icrucumab

Biological: Icrucumab; Drug: mFOLFOX-6

Interventions

Icrucumab BIOLOGICAL

15 mg/kg IV Q2W

Also known as: IMC-18F1, LY3012212

mFOLFOX-6 + Icrucumab

mFOLFOX-6 DRUG

Oxaliplatin: 85 milligram per square meter (mg/m²) IV every 2 weeks (Q2W) FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable). 5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W

mFOLFOX-6; mFOLFOX-6 + Icrucumab; mFOLFOX-6 + Ramucirumab

Ramucirumab BIOLOGICAL

8 mg/kg IV Q2W

Also known as: IMC-1121B, LY3009806

mFOLFOX-6 + Ramucirumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Disease progression on an irinotecan-based first-line chemotherapy regimen (ie FOLFIRI or CAPIRI \[capecitabine + irinotecan\], with or without bevacizumab)
• Age ≥ 18 years
• Life expectancy of ≥ 6 months
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1 at study entry
• Agrees to adequate contraception during the study period and for 12 weeks after the last dose of study medication
• Provided signed informed consent

You may not qualify if:

• Has received prior oxaliplatin-based chemotherapy for locally advanced unresectable or metastatic Colorectal Cancer (CRC) (Prior oxaliplatin-based adjuvant chemotherapy is allowed if the last dose of oxaliplatin was administered \> 12 months prior to randomization)
• Has documented and/or symptomatic brain or leptomeningeal metastases
• Has an ongoing or active infection, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders
• On chronic non-topical corticosteroid treatment. A participant discontinuing such treatment \> 3 months prior to randomization is eligible
• Has uncontrolled or poorly controlled hypertension on a standard regimen of antihypertensive therapy
• Has a concurrent active malignancy. A participant with previous history of malignancy is eligible, provided that he/she has been disease free for \> 3 years
• If female, is pregnant (confirmed by serum beta human chorionic gonadotropin \[βHCG\] test) or lactating
• Has received a prior autologous or allogeneic organ or tissue transplantation
• Has undergone major surgery within 28 days prior to randomization
• Has had a serious nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization
• Has an elective or planned major surgery to be performed during the course of the trial
• Has a history of inflammatory bowel disease requiring pharmacological and/or surgical intervention in the 12 months prior to randomization

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (17)

ImClone Investigational Site

Cincinnati, Ohio, 45242, United States

Location

ImClone Investigational Site

Columbia, South Carolina, 29210, United States

Location

ImClone Investigational Site

Nashville, Tennessee, 37232, United States

Location

ImClone Investigational Site

Calgary, Alberta, T2N 4N2, Canada

Location

ImClone Investigational Site

Edmonton, Alberta, T6G 1Z2, Canada

Location

ImClone Investigational Site

Kelowna, British Columbia, V1Y 5L3, Canada

Location

ImClone Investigational Site

Surrey, British Columbia, V3V 1Z2, Canada

Location

ImClone Investigational Site

Vancouver, British Columbia, V5Z 4E6, Canada

Location

ImClone Investigational Site

Halifax, Nova Scotia, B3H 1V7, Canada

Location

ImClone Investigational Site

Hamilton, Ontario, L8V 5C2, Canada

Location

ImClone Investigational Site

London, Ontario, N6A 4L6, Canada

Location

ImClone Investigational Site

Mississauga, Ontario, L5M 2N1, Canada

Location

ImClone Investigational Site

Oshawa, Ontario, L1G 2B9, Canada

Location

ImClone Investigational Site

Ottawa, Ontario, K1H 8L6, Canada

Location

ImClone Investigational Site

Toronto, Ontario, M5G 2M9, Canada

Location

ImClone Investigational Site

Windsor, Ontario, N8W 2X3, Canada

Location

ImClone Investigational Site

Montreal, Quebec, H2W 156, Canada

Location

Related Publications (1)

• Moore M, Gill S, Asmis T, Berry S, Burkes R, Zbuk K, Alcindor T, Jeyakumar A, Chan T, Rao S, Spratlin J, Tang PA, Rothenstein J, Chan E, Bendell J, Kudrik F, Kauh J, Tang S, Gao L, Kambhampati SR, Nasroulah F, Yang L, Ramdas N, Binder P, Strevel E. Randomized phase II study of modified FOLFOX-6 in combination with ramucirumab or icrucumab as second-line therapy in patients with metastatic colorectal cancer after disease progression on first-line irinotecan-based therapy. Ann Oncol. 2016 Dec;27(12):2216-2224. doi: 10.1093/annonc/mdw412. Epub 2016 Oct 11.

  PMID: 27733377 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms; Adenocarcinoma

Interventions

Ramucirumab; Icrucumab; IMC-18F1

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Compnay

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2010
• First Posted: April 27, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 6, 2019
• Results First Posted: August 6, 2019

Record last verified: 2019-07

Locations

CA (14); US (3)