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Sponsored by: |
ImClone Systems |
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Information provided by: | ImClone Systems |
ClinicalTrials.gov Identifier: | NCT00503685 |
Patients with mCRC who have progressed on a prior Anti-EGFr regimen randomized to receive IMC-A12 monotherapy or combination therapy with cetuximab to assess response, survival, durations of response, safety and tolerability as well as pharmacodynamics of IMC-A12 and cetuximab
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: IMC-A12 Drug: IMC-A12 + cetuximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Phase II Clinical Trial of IMC-A12, as a Single Agent, or in Combination Wih Cetuximab, in Patients With Metastatic Colorectal Cancer With Disease Progression on Prior Anti-EGFr Therapy |
Estimated Enrollment: | 72 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Open label, randomized, phase II trial. Patients in Arm A will receive single agent IMC-A12 10 mg/kg I.V. over 1 hour every 2 weeks. Patients randomized to Arm A or Arm B should continue to receive treatment until there is evidence of progressive disease, unacceptable toxicity, or withdrawn consent. Pharmacokinetic and pharmacodynamic assessments will be performed using samples from the first 10 patients enrolled in each arm at Memorial Sloan Kettering Cancer Center (20 patients total).
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Drug: IMC-A12
IMC-A12 injection for intravenous use, supplied in single-use 90 mg/20-mL or 250 mg/50-mL vials containing 4.5 mg/mL in phosphate-buffered saline or 5 mg/mL in citrate-based saline, respectively, and administered at a dose of 10 mg/kg every 2 weeks.
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B: Experimental
Patients in Arm B will receive cetuximab 500 mg/m2 I.V. over 2 hours,followed by a 1 hour observation period, then IMC-A12 10 mg/kg administered intravenously over 1 hour (both treatments will be administered every 2 weeks). Pharmacokinetic and pharmacodynamic assessments will be performed using samples from the first 10 patients enrolled in each arm at Memorial Sloan Kettering Cancer Center (20 patients total). |
Drug: IMC-A12 + cetuximab
IMC-A12 injection for intravenous use, supplied in single-use 90 mg/20-mL or 250 mg/50-mL vials containing 4.5 mg/mL in phosphate-buffered saline or 5 mg/mL in citrate-based saline, respectively, and administered at a dose of 10 mg/kg every 2 weeks. Cetuximab injection for intravenous use, supplied by ImClone Systems in single-use, 100 mg/50-mL or 200 mg/100-mL vials as sterile, preservative-free injectable liquid, and administered intravenously via an infusion pump or gravity drip, at 500 mg/m2 (over 120 minutes) every 2 weeks. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
The patient experienced either a confirmed partial response or stable disease of ≥ 24 weeks duration during prior treatment with a cetuximab- or panitumumab-containing regimen.
Except for patients with UGT1A1 promoter polymorphism, ie, Gilbert syndrome, confirmed by genotyping or Invader®UGT1A1 Molecular Assay prior to enrollment. Patients enrolled with Gilbert Syndrome must have a total bilirubin ≤ 3 x ULN. If the patient has liver metastases, total bilirubin must be
Exclusion Criteria
United States, California | |
UCLA Medical Center | |
Los Angeles, California, United States, 90095 | |
United States, Connecticut | |
Yale Comprehensive Cancer Center | |
New Haven, Connecticut, United States, 06520 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263 |
Principal Investigator: | Leonard B Saltz, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | ImClone Systems Incorporated ( Eric Rowinsky/ Chief Medical Officer ) |
Study ID Numbers: | CP13-0605 |
Study First Received: | July 17, 2007 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00503685 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Metastatic Colorectal Cancer with Disease Progression Failed prior to Anti-EGFr Therapy |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Citric Acid Cetuximab Colonic Diseases |
Disease Progression Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
Disease Attributes Digestive System Neoplasms Antineoplastic Agents Gastrointestinal Diseases Cetuximab Colonic Diseases Disease Progression Intestinal Diseases Rectal Diseases |
Pharmacologic Actions Intestinal Neoplasms Neoplasms Pathologic Processes Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Colorectal Neoplasms |