Safety and Efficacy Study of MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI as Second Line Therapy in Participants With KRAS Wild-Type Metastatic Colorectal Cancer (mCRC)
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| ClinicalTrials.gov Identifier: NCT01652482 |
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Recruitment Status :
Completed
First Posted : July 30, 2012
Last Update Posted : November 2, 2016
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Sponsor:
Genentech, Inc.
Information provided by (Responsible Party):
Genentech, Inc.
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Brief Summary:
This open-label, randomized, multicenter, Phase 2 study will evaluate the safety and efficacy of MEHD7945A when combined with FOLFIRI (folinic acid [leucovorin], 5-fluorouracil [5-FU], and irinotecan) chemotherapy as compared to cetuximab plus FOLFIRI in participants with Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) wild-type mCRC who have progressed after first-line oxaliplatin-containing chemotherapy for metastatic disease. Participants will be randomized to receive FOLFIRI chemotherapy plus either MEHD7945A or cetuximab. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Colorectal Cancer | Drug: 5-fluorouracil Drug: Cetuximab Drug: Irinotecan Drug: Leucovorin Drug: MEHD7945A | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 135 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | October 2012 |
| Actual Primary Completion Date : | November 2014 |
| Actual Study Completion Date : | November 2014 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Cetuximab
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: FOLFIRI + Cetuximab |
Drug: 5-fluorouracil
Standard 5-fluorouracil (5-FU) chemotherapy (400 milligram per square meter [mg/m^2] administered as intravenous bolus and then 5-FU 2400 mg/m^2 administered as continuous intravenous infusion over 46 +/- 2 hours) or according to local standard-of-care prescribing information's, every 2 weeks until documented disease progression or unacceptable toxicity.
Other Name: ADRUCIL Drug: Cetuximab Cetuximab 400 mg/m^2 intravenous infusion as a loading dose on Day 1 Cycle 1, followed by 250 mg/m^2 intravenous infusion weekly until documented disease progression or unacceptable toxicity.
Other Name: Erbitux Drug: Irinotecan Standard Irinotecan chemotherapy (180 milligram per square meter [mg/m^2] administered as intravenous infusion over 60 +/- 30 minutes) or according to local standard-of-care prescribing information's, every 2 weeks until documented disease progression or unacceptable toxicity.
Other Name: CAMPTOSAR Drug: Leucovorin Standard Leucovorin chemotherapy (400 mg/m^2 [racemic form] or 200 mg/m^2 [L-isomer form] administered by intravenous infusion over 120 +/- 10 minutes) or according to local standard-of-care prescribing information's, every 2 weeks until documented disease progression or unacceptable toxicity.
Other Name: WELLCOVORIN |
| Experimental: FOLFIRI + MEHD7945A |
Drug: 5-fluorouracil
Standard 5-fluorouracil (5-FU) chemotherapy (400 milligram per square meter [mg/m^2] administered as intravenous bolus and then 5-FU 2400 mg/m^2 administered as continuous intravenous infusion over 46 +/- 2 hours) or according to local standard-of-care prescribing information's, every 2 weeks until documented disease progression or unacceptable toxicity.
Other Name: ADRUCIL Drug: Irinotecan Standard Irinotecan chemotherapy (180 milligram per square meter [mg/m^2] administered as intravenous infusion over 60 +/- 30 minutes) or according to local standard-of-care prescribing information's, every 2 weeks until documented disease progression or unacceptable toxicity.
Other Name: CAMPTOSAR Drug: Leucovorin Standard Leucovorin chemotherapy (400 mg/m^2 [racemic form] or 200 mg/m^2 [L-isomer form] administered by intravenous infusion over 120 +/- 10 minutes) or according to local standard-of-care prescribing information's, every 2 weeks until documented disease progression or unacceptable toxicity.
Other Name: WELLCOVORIN Drug: MEHD7945A MEHD7945A 1100 milligram (mg) intravenous infusion every 2 weeks until documented disease progression or unacceptable toxicity. |
Primary Outcome Measures :
- Progression-free Survival (PFS) According to Modified RECIST v1.1 Criteria [ Time Frame: approximately 2 year ]
Secondary Outcome Measures :
- Plasma Concentration of 5-Fluorouracil [ Time Frame: Pre-dose, 1 hour and after end of infusion on Day 1 Cycles 1-4 ]
- Plasma Concentration of Irinotecan [ Time Frame: Pre-dose, 1 hour and after end of infusion on Day 1 Cycles 1-4 ]
- Number of Participants With Anti-MEHD7945A Antibodies [ Time Frame: Pre-dose on Day 1 Cycles 1, 4, and 8; treatment completion visit (up to approximately 2 years) ]
- Number of Participants With Objective Response According to Modified RECIST v1.1 Criteria [ Time Frame: approximately 2 year ]
- Duration of Objective Response According to Modified RECIST v1.1 Criteria [ Time Frame: approximately 2 year ]
- Overall Survival (OS) [ Time Frame: approximately 2 year ]
- Number of Participants With Adverse Events [ Time Frame: approximately 2 year ]
- Maximum Observed Serum Concentration (Cmax) of MEHD7945A [ Time Frame: Pre-dose and 30 minutes after end of infusion on Day 1 Cycles 1-4, Cycle 8 and at treatment completion (up to approximately 2 year) ]
- Minimum Observed Serum Concentration (Cmin) of MEHD7945A [ Time Frame: Pre-dose on Day 1 Cycles 1-4, Cycle 8 and at treatment completion (up to approximately 2 year) ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 mCRC; participants must have received oxaliplatin-containing chemotherapy for greater than or equal to (>/=) 3 months; no more than one prior chemotherapy regimen for metastatic disease is allowed
- Measurable disease per modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate hematologic and end-organ function
Exclusion Criteria:
- Prior treatment with irinotecan
- Prior treatment with an investigational or approved human epidermal growth factor receptor (HER)-targeted agent
- Last anti-tumor therapy within 4 weeks prior to Cycle 1, Day 1
- Leptomeningeal disease as the only manifestation of the current malignancy
- Active infection requiring intravenous antibiotics
- Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs
- Current severe, uncontrolled systemic disease
- Known human immunodeficiency virus (HIV) infection
- Untreated/active central nervous system 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01652482
Locations
Show 65 study locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
| Study Director: | Clinical Trials | Genentech, Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Genentech, Inc. |
| ClinicalTrials.gov Identifier: | NCT01652482 |
| Other Study ID Numbers: |
GO28074 2011-005547-27 ( EudraCT Number ) |
| First Posted: | July 30, 2012 Key Record Dates |
| Last Update Posted: | November 2, 2016 |
| Last Verified: | November 2016 |
Additional relevant MeSH terms:
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Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Leucovorin Fluorouracil Irinotecan Cetuximab |
Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Antidotes Protective Agents Vitamin B Complex Vitamins Micronutrients |