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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01652482
First received: July 26, 2012
Last updated: July 15, 2014
Last verified: July 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 t

o cetuximab plus FOLFIRI in patients with KRAS wild-type metastatic colorectal c ancer who have progressed after first-line oxaliplatin-containing chemotherapy f or metastatic disease. Patients will be randomized to receive FOLFIRI chemothera py plus either MEHD7945A (1100 mg intravenously every 2 weeks) or cetuximab (400 mg/m2 iv loading dose Day 1 Cycle 1, followed by 250 mg/m2 iv every week). Antic ipated time on study treatment is until disease progression or unacceptable toxi city 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 ]

Estimated Enrollment: 120
Study Start Date: October 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01652482

Contacts
Contact: Reference Study ID Number: GO28074 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Hide Study Locations
Locations
United States, California
Completed
Bakersfield, California, United States, 93309
Completed
Fullerton, California, United States, 92835
Completed
Los Angeles, California, United States, 90033
Completed
Los Angeles, California, United States, 90095
Completed
San Luis Obispo, California, United States, 93454
Recruiting
Santa Barbara, California, United States, 93105
United States, Colorado
Completed
Aurora, Colorado, United States, 80045
United States, Florida
Recruiting
Orange Park, Florida, United States, 32073
United States, Illinois
Completed
Harvey, Illinois, United States, 60426
United States, Kentucky
Completed
Paducah, Kentucky, United States, 42003
United States, Maryland
Completed
Rockville, Maryland, United States, 20850
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States, 02114
Completed
Boston, Massachusetts, United States, 02215
United States, Michigan
Completed
Detroit, Michigan, United States, 48201
United States, Missouri
Completed
Jefferson City, Missouri, United States, 65109
United States, Nevada
Completed
Las Vegas, Nevada, United States, 89148
United States, Pennsylvania
Completed
Philadelphia, Pennsylvania, United States, 19104
United States, Washington
Not yet recruiting
Kirkland, Washington, United States, 98034
Completed
Seattle, Washington, United States, 98109
Australia, New South Wales
Recruiting
Darlinghurst, New South Wales, Australia, 2010
Completed
New Lambton Heights, New South Wales, Australia, 2305
Completed
St. Leonards, New South Wales, Australia, 2065
Completed
Sydney, New South Wales, Australia, 2217
Recruiting
Waratah, New South Wales, Australia, 2298
Recruiting
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
Completed
Herston, Queensland, Australia, 4029
Active, not recruiting
Southport, Queensland, Australia, 4215
Australia, South Australia
Completed
Adelaide, South Australia, Australia, 5041
Australia, Victoria
Completed
Frankston, Victoria, Australia, 3199
Belgium
Completed
Bruxelles, Belgium, 1200
Completed
Charleroi, Belgium, 6000
Recruiting
Haine-saint-paul, Belgium, 7100
Completed
Leuven, Belgium, 3000
Recruiting
Liege, Belgium, 4000
France
Completed
Creteil, France, 94000
Completed
Lyon, France, 69373
Completed
Paris, France, 75015
Completed
Villejuif, France, 94805
Germany
Completed
Dresden, Germany, 01307
Active, not recruiting
München, Germany, 81737
Completed
München, Germany, 81925
Recruiting
Stuttgart, Germany, 70199
Completed
Trier, Germany, 54290
Italy
Completed
Milano, Lombardia, Italy, 20162
Not yet recruiting
Milano, Lombardia, Italy, 20141
Completed
Milano, Lombardia, Italy, 20133
Recruiting
Orbassano, Piemonte, Italy, 10043
Completed
Pisa, Toscana, Italy, 56100
Completed
Padova, Veneto, Italy, 35128
New Zealand
Completed
Auckland, New Zealand, 1142
Completed
Christchurch, New Zealand, 8011
Active, not recruiting
Dunedin, New Zealand, 9001
Active, not recruiting
Tauranga, New Zealand, 3143
Romania
Completed
Brasov, Romania, 500091
Completed
Bucharest, Romania, 022328
Completed
Bucuresti, Romania, 030171
Completed
Iasi, Romania, 700106
Spain
Completed
Barcelona, Spain, 08036
Active, not recruiting
Barcelona, Spain, 08035
Completed
Madrid, Spain, 28041
Completed
Madrid, Spain, 28050
Active, not recruiting
Valencia, Spain, 46010
United Kingdom
Completed
Aberdeen, United Kingdom, AB25 2ZN
Completed
London, United Kingdom, NW1 2BU
Completed
Oxford, United Kingdom, OX3 7LJ
Completed
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: July 15, 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 July 22, 2014