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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.
Verified February 2013 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01652482
First received: July 26, 2012
Last updated: February 26, 2013
Last verified: February 2013
History of Changes
  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:

Drug Information available for: Cetuximab
U.S. FDA Resources

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: March 2016
Estimated Primary Completion Date: August 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

Contacts
Contact: Please reference Study ID Number: GO28074 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Show 59 Study Locations
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: February 26, 2013
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 May 16, 2013