A Study of IMC-1121B or IMC-18F1 in Colorectal Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
ImClone LLC
Information provided by (Responsible Party):
ImClone LLC
ClinicalTrials.gov Identifier:
NCT01111604
First received: April 8, 2010
Last updated: May 6, 2013
Last verified: March 2013
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Purpose
The purpose of this study is to determine if patients with metastatic colorectal cancer live longer without their cancer progressing when treated with standard chemotherapy, standard chemotherapy plus IMC-1121B, or standard chemotherapy plus IMC-18F1.
| Condition | Intervention | Phase |
|---|---|---|
|
Colon Cancer Rectal Cancer |
Biological: IMC-1121B Biological: IMC-18F1 Drug: mFOLFOX-6 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of 5 FU/FA and Oxaliplatin (Modified FOLFOX 6) in Combination With IMC-1121B or IMC-18F1 or Without Investigational Therapy as Second Line Therapy in Patients With Metastatic Colorectal Cancer Following Disease Progression on First Line Irinotecan-based Therapy |
Resource links provided by NLM:
Further study details as provided by ImClone LLC:
Primary Outcome Measures:
- Progression-free survival (PFS) [ Time Frame: 31 Weeks ] [ Designated as safety issue: No ]PFS is defined as the time from the date of randomization until the date of objectively determined progression as defined by RECIST v1.1, or death from any cause, whichever is first.
Secondary Outcome Measures:
- Objective response rate (ORR) [ Time Frame: 31 Weeks ] [ Designated as safety issue: No ]The ORR is the proportion of all randomized patients with Partial Response (PR) or Complete Response (CR) according to RECIST v1.1 from the start of the treatment until disease progression/recurrence
- Overall survival (OS) [ Time Frame: 31 Weeks ] [ Designated as safety issue: No ]Overall survival is defined as the time from the date of randomization to the date of death from any cause. If the patient is alive at the end of the follow-up period or is lost to follow-up, OS will be censored on the last date the patient is known to be alive.
- Duration of response [ Time Frame: 31 Weeks ] [ Designated as safety issue: No ]Is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that the criteria for PD is met (taking as a reference for PD that smallest measurement recorded since the treatment started), or death, is objectively documented.
- Maximum concentration (Cmax) at Day 1 [ Time Frame: Day 1 (cycles 1, 5, 9, and 13) ] [ Designated as safety issue: No ]Maximum concentration (Cmax) is the maximum peak concentration measured in blood plasma after drug infusion.
- Maximum concentration (Cmax) at Day 4 [ Time Frame: Day 4 (cycles 1 and 5) ] [ Designated as safety issue: No ]Maximum concentration (Cmax) is the maximum peak concentration measured in blood plasma after drug infusion.
- Maximum concentration (Cmax) at Day 8 [ Time Frame: Day 8 (cycles 1 and 5) ] [ Designated as safety issue: No ]Maximum concentration (Cmax) is the maximum peak concentration measured in blood plasma after drug infusion.
- Maximum concentration (Cmax) at Day 15 [ Time Frame: Day 15 (cycles 1 and 5) ] [ Designated as safety issue: No ]Maximum concentration (Cmax) is the maximum peak concentration measured in blood plasma after drug infusion.
- Minimum concentration (Cmin) at Day 1 [ Time Frame: Day 1 (cycles 1, 5, 9, and 13) ] [ Designated as safety issue: No ]Minimum concentration (Cmin) is the minimum peak concentration measured in blood plasma after drug infusion.
- Minimum concentration (Cmin) at Day 4 [ Time Frame: Day 4 (cycles 1 and 5) ] [ Designated as safety issue: No ]Minimum concentration (Cmin) is the minimum peak concentration measured in blood plasma after drug infusion.
- Minimum concentration (Cmin) at Day 8 [ Time Frame: Day 8 (cycles 1 and 5) ] [ Designated as safety issue: No ]Minimum concentration (Cmin) is the minimum peak concentration measured in blood plasma after drug infusion.
- Minimum concentration (Cmin) at Day 15 [ Time Frame: Day 15 (cycles 1 and 5) ] [ Designated as safety issue: No ]Minimum concentration (Cmin) is the minimum peak concentration measured in blood plasma after drug infusion.
- Serum Anti-1121B Antibody Assessment [ Time Frame: 31 Weeks ] [ Designated as safety issue: Yes ]A sample will be considered positive for anti-IMC-1121B antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-IMC-1121B antibody level seen in healthy untreated individuals.
- Serum Anti-IMC-18F1 Antibody Assessment [ Time Frame: 31 Weeks ] [ Designated as safety issue: Yes ]A sample will be considered positive for anti-IMC-18F1 antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-IMC-18F1 antibody level seen in healthy untreated individuals.
- Number of Participants with Adverse Events [ Time Frame: 31 Weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 157 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: mFOLFOX-6
mFOLFOX-6
|
Drug: mFOLFOX-6
Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable). 5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks |
|
Experimental: mFOLFOX-6 + IMC-1121B
mFOLFOX-6 + IMC-1121B
|
Biological: IMC-1121B
8 mg/kg I.V. infusion, administered every 2 weeks
Other Names:
Drug: mFOLFOX-6
Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable). 5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks |
|
Experimental: mFOLFOX-6 + IMC-18F1
mFOLFOX-6 + IMC-18F1
|
Biological: IMC-18F1
15 mg/kg I.V. infusion, administered every 2 weeks
Other Name: LY3012212
Drug: mFOLFOX-6
Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable). 5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks |
Detailed Description:
The purpose of this study is to evaluate the progression-free survival (PFS) in patients with metastatic colorectal cancer when treated with 1 of 3 modified FOLFOX-6 (folinic acid [FA] + fluorouracil [5-FU] + oxaliplatin [mFOLFOX-6])-based regimens, as second-line therapy.
During 2010, there has been an identified shortage of injectable folinic acid (FA) in the United States. Levo-folinic acid (LFA) will be allowed as a substitute for FA in the mFOLFOX-6 chemotherapy regimen in circumstances in which FA is not available, to facilitate continuity of patient care.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
- ECOG PS (Eastern Cooperative Oncology Group Performance Status) 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
Exclusion Criteria:
- Has received prior oxaliplatin-based chemotherapy for locally advanced unresectable or metastatic 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 patient 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 patient 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01111604
Locations
| United States, Ohio | |
| ImClone Investigational Site | |
| Cincinnati, Ohio, United States, 45242 | |
| United States, South Carolina | |
| ImClone Investigational Site | |
| Columbia, South Carolina, United States, 29210 | |
| United States, Tennessee | |
| ImClone Investigational Site | |
| Nashville, Tennessee, United States, 37232 | |
| Canada, Alberta | |
| ImClone Investigational Site | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| ImClone Investigational Site | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, British Columbia | |
| ImClone Investigational Site | |
| Kelowna, British Columbia, Canada, V1Y 5L3 | |
| ImClone Investigational Site | |
| Surrey, British Columbia, Canada, V3V 1Z2 | |
| ImClone Investigational Site | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Canada, Nova Scotia | |
| ImClone Investigational Site | |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Canada, Ontario | |
| ImClone Investigational Site | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| ImClone Investigational Site | |
| London, Ontario, Canada, N6A 4L6 | |
| ImClone Investigational Site | |
| Mississauga, Ontario, Canada, L5M 2N1 | |
| ImClone Investigational Site | |
| Oshawa, Ontario, Canada, L1G 2B9 | |
| ImClone Investigational Site | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| ImClone Investigational Site | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| ImClone Investigational Site | |
| Windsor, Ontario, Canada, N8W 2X3 | |
| Canada, Quebec | |
| ImClone Investigational Site | |
| Montreal, Quebec, Canada, H2W 156 | |
Sponsors and Collaborators
ImClone LLC
Investigators
| Study Director: | E-mail: ClinicalTrials@ImClone.com | ImClone LLC |
More Information
No publications provided
| Responsible Party: | ImClone LLC |
| ClinicalTrials.gov Identifier: | NCT01111604 History of Changes |
| Other Study ID Numbers: | 13942, CP20-0801, I4Y-IE-JCDB |
| Study First Received: | April 8, 2010 |
| Last Updated: | May 6, 2013 |
| Health Authority: | Canada: Health Canada United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by ImClone LLC:
|
Colonic Neoplasms Rectal Neoplasms Adenocarcinoma Antibodies, Monoclonal |
Additional relevant MeSH terms:
|
Colonic Neoplasms Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 22, 2013