A Study of MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI in Second Line in Patients With KRAS Wild-Type Metastatic Colorectal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01652482
First received: July 26, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

This open-label, randomized, multicenter Phase II study will evaluate the safety and efficacy of MEHD7945A when combined with FOLFIRI chemotherapy as compared to cetuximab plus FOLFIRI in patients with KRAS wild-type metastatic colorectal cancer who have progressed after first-line oxaliplatin-containing chemotherapy for metastatic disease. Patients will be randomized to receive FOLFIRI chemotherapy plus either MEHD7945A (1100 mg intravenously every 2 weeks) or cetuximab (400mg/m2 iv loading dose Day 1 Cycle 1, followed by 250 mg/m2 iv every week). Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Condition Intervention Phase
Colorectal Cancer
Drug: MEHD7945A
Drug: cetuximab
Drug: FOLFIRI
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: A Phase II, Multicenter, Open-Label, Randomized Study Evaluating the Efficacy and Safety of MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI in Second Line in Patients With KRAS Wildtype Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Progression-free survival (tumor assessments according to RECIST v1.1 criteria) [ Time Frame: approximately 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate (complete response + partial response) [ Time Frame: approximately 8 months ] [ Designated as safety issue: No ]
  • Duration of objective response [ Time Frame: approximately 8 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: approximately 17 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 9 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics of MEHD7945A in combination with FOLFIRI: Area under the concentration-time curve (AUC) [ Time Frame: Pre-dose and 30 min after end of infusion Day 1 Cycles 1-4, pre-dose Day 1 Cycles 10 and 16 ] [ Designated as safety issue: No ]
  • Incidence of anti-MEHD7945A antibodies [ Time Frame: Pre-dose Day 1 Cycles 1 and 4, and at treatment completion ] [ Designated as safety issue: No ]

Enrollment: 135
Study Start Date: October 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: FOLFIRI + MEHD7945A Drug: MEHD7945A
1100 mg iv every 2 weeks
Drug: FOLFIRI
Standard FOLFIRI (irinotecan/5-FU/leucovorin) chemotherapy every 2 weeks
Active Comparator: B: FOLFIRI + cetuximab Drug: cetuximab
400 mg/m2 iv loading dose Day 1 Cycle 1, followed by 250 mg/m2 weekly
Drug: FOLFIRI
Standard FOLFIRI (irinotecan/5-FU/leucovorin) chemotherapy every 2 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Histologically or cytologically confirmed adenocarcinoma of the colon and/or rectum, with KRAS wild-type status
  • Progressive disease on or after first-line oxaliplatin-containing regimen for metastatic colorectal cancer; patients must have received oxaliplatin-containing chemotherapy for >/= 3 months; no more than one prior chemotherapy for metastatic disease is allowed
  • Measurable disease per RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate hematologic and end-organ function

Exclusion Criteria:

  • Prior treatment with irinotecan
  • Prior treatment with an investigational or approved HER-targeted agent
  • Last anti-tumor therapy within 4 weeks prior to Cycle 1, Day 1, including chemotherapy, biologic, experimental, hormonal or radiotherapy, or not having recovered from all treatment-related toxicities (except for alopecia) to Grade </=1, with the following exceptions: oxaliplatin-containing chemotherapy within 2 weeks prior to Cycle 1, Day 1, oxaliplatin-related neuropathy that is Grade </= 2 and considered stable, and palliative radiotherapy to bone metastases within 2 weeks prior to Cycle 1, Day 1
  • Leptomeningeal disease as the only manifestation of the current malignancy
  • Active infection requiring IV antibiotics
  • Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs
  • Current severe , uncontrolled systemic disease
  • History of cardiac heart failure or serious cardiac arrhythmia requiring treatment (except for atrial fibrillation and paroxysmal supraventricular tachycardia)
  • History of myocardial infarction within 6 months prior to Cycle 1 Day 1, or history of unstable angina
  • Clinically significant GI bleeding within 6 months prior to Cycle 1 Day 1
  • History of severe (Grade 3 or 4) allergic or hypersensitivity reaction to therapeutic antibodies that required discontinuation of treatment
  • Known HIV infection
  • Untreated CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
  • Pregnant or lactating women
  • Malignancies other than colorectal cancer within 5 years prior to randomization, except for adequately treated basal or squamous cell skin cancer and carcinoma in situ of the cervix
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652482

  Hide Study Locations
Locations
United States, California
Bakersfield, California, United States, 93309
Fullerton, California, United States, 92835
Los Angeles, California, United States, 90033
Los Angeles, California, United States, 90095
San Luis Obispo, California, United States, 93454
Santa Barbara, California, United States, 93105
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Orange Park, Florida, United States, 32073
United States, Illinois
Harvey, Illinois, United States, 60426
United States, Kentucky
Paducah, Kentucky, United States, 42003
United States, Maryland
Rockville, Maryland, United States, 20850
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States, 02215
United States, Michigan
Detroit, Michigan, United States, 48201
United States, Missouri
Jefferson City, Missouri, United States, 65109
United States, Nevada
Las Vegas, Nevada, United States, 89148
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Washington
Kirkland, Washington, United States, 98034
Seattle, Washington, United States, 98109
Australia, New South Wales
Darlinghurst, New South Wales, Australia, 2010
New Lambton Heights, New South Wales, Australia, 2305
St. Leonards, New South Wales, Australia, 2065
Sydney, New South Wales, Australia, 2217
Waratah, New South Wales, Australia, 2298
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
Herston, Queensland, Australia, 4029
Southport, Queensland, Australia, 4215
Australia, South Australia
Adelaide, South Australia, Australia, 5041
Australia, Victoria
Frankston, Victoria, Australia, 3199
Belgium
Bruxelles, Belgium, 1200
Charleroi, Belgium, 6000
Haine-saint-paul, Belgium, 7100
Leuven, Belgium, 3000
Liege, Belgium, 4000
France
Creteil, France, 94000
Lyon, France, 69373
Paris, France, 75015
Villejuif, France, 94805
Germany
Dresden, Germany, 01307
München, Germany, 81737
München, Germany, 81925
Stuttgart, Germany, 70199
Trier, Germany, 54290
Italy
Milano, Lombardia, Italy, 20162
Milano, Lombardia, Italy, 20141
Milano, Lombardia, Italy, 20133
Orbassano, Piemonte, Italy, 10043
Pisa, Toscana, Italy, 56100
Padova, Veneto, Italy, 35128
New Zealand
Auckland, New Zealand, 1142
Christchurch, New Zealand, 8011
Dunedin, New Zealand, 9001
Tauranga, New Zealand, 3143
Romania
Brasov, Romania, 500091
Bucharest, Romania, 022328
Bucuresti, Romania, 030171
Iasi, Romania, 700106
Spain
Barcelona, Spain, 08036
Barcelona, Spain, 08035
Madrid, Spain, 28041
Madrid, Spain, 28050
Valencia, Spain, 46010
United Kingdom
Aberdeen, United Kingdom, AB25 2ZN
London, United Kingdom, NW1 2BU
Oxford, United Kingdom, OX3 7LJ
Wirral, United Kingdom, CH63 4JY
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01652482     History of Changes
Other Study ID Numbers: GO28074, 2011-005547-27
Study First Received: July 26, 2012
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014