Colorectal CancerPhase 2NCT01652482
Safety and Efficacy Study of MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI as Second Line Therapy in Participants With KRAS Wild-Type Metastatic Colorectal Cancer (mCRC)
A Phase 2 study testing 5-fluorouracil, Cetuximab and Irinotecan in people with Colorectal Cancer, run by Genentech, Inc. at 65 sites in 10 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- 5-fluorouracil, Cetuximab and Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 65 sitesin 10 countries
- Study dates
- Oct 2012to Nov 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
65 sites in 10 countries.
65 sites in 10 countries
United States19 sites
Study site
Aurora, Colorado, 80045
Study site
Bakersfield, California, 93309
Study site
Boston, Massachusetts, 02114
Study site
Boston, Massachusetts, 02215
Study site
Detroit, Michigan, 48201
Study site
Fullerton, California, 92835
Study site
Harvey, Illinois, 60426
Study site
Jefferson City, Missouri, 65109
Study site
Kirkland, Washington, 98034
Study site
Las Vegas, Nevada, 89148
Study site
Los Angeles, California, 90033
Study site
Los Angeles, California, 90095
Study site
Orange Park, Florida, 32073
Study site
Paducah, Kentucky, 42003
Study site
Philadelphia, Pennsylvania, 19104
Study site
Rockville, Maryland, 20850
Study site
San Luis Obispo, California, 93454
Study site
Santa Barbara, California, 93105
Study site
Seattle, Washington, 98109
Australia10 sites
Study site
Adelaide, South Australia, 5041
Study site
Darlinghurst, New South Wales, 2010
Study site
Frankston, Victoria, 3199
Study site
Herston, Queensland, 4029
Study site
New Lambton Heights, New South Wales, 2305
Study site
Southport, Queensland, 4215
Study site
St Leonards, New South Wales, 2065
Study site
Sydney, New South Wales, 2217
Study site
Waratah, New South Wales, 2298
Study site
Wollongong, New South Wales, 2500
Belgium5 sites
Study site
Brussels, 1200
Study site
Charleroi, B6000
Study site
Haine-Saint-Paul, 7100
Study site
Leuven, 3000
Study site
Liège, 4000
Germany5 sites
Study site
Dresden, 01307
Study site
München, 81737
Study site
München, 81925
Study site
Stuttgart, 70199
Study site
Trier, 54290
Italy5 sites
Study site
Milan, Lombardy, 20133
Study site
Milan, Lombardy, 20162
Study site
Orbassano, Piedmont, 10043
Study site
Padova, Veneto, 35128
Study site
Pisa, Tuscany, 56100
Spain5 sites
Study site
Barcelona, Barcelona, 08035
Study site
Barcelona, Barcelona, 08036
Study site
Madrid, Madrid, 28007
Study site
Madrid, Madrid, 28050
Study site
Valencia, Valencia, 46010
France4 sites
Study site
Créteil, 94000
Study site
Lyon, 69373
Study site
Paris, 75015
Study site
Villejuif, 94805
New Zealand4 sites
Study site
Auckland, 1142
Study site
Christchurch, 8011
Study site
Dunedin, 9001
Study site
Tauranga, 3112
Romania4 sites
Study site
Brasov, 500091
Study site
Bucharest, 022328
Study site
Bucharest, 030171
Study site
Iași, 700106
United Kingdom4 sites
Study site
Aberdeen, AB25 2ZN
Study site
London, NW1 2BU
Study site
Metropolitan Borough of Wirral, CH63 4JY
Study site
Oxford, OX3 7LJ
About this study
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
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.
- Conditions
- Colorectal Cancer
- Being tested
- 5-fluorouracil, Cetuximab, Irinotecan, Leucovorin, MEHD7945A
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-fluorouracilDrug
Also called ADRUCIL
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.
CetuximabDrug
Also called Erbitux
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.
IrinotecanDrug
Also called CAMPTOSAR
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.
LeucovorinDrug
Also called WELLCOVORIN
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.
MEHD7945ADrug
MEHD7945A 1100 milligram (mg) intravenous infusion every 2 weeks until documented disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| FOLFIRI + Cetuximab | Active comparator | Not described Receives: Drug: 5-fluorouracil; Drug: Cetuximab; Drug: Irinotecan; Drug: Leucovorin |
| FOLFIRI + MEHD7945A | Experimental | Not described Receives: Drug: 5-fluorouracil; Drug: Irinotecan; Drug: Leucovorin; Drug: MEHD7945A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) According to Modified RECIST v1.1 Criteria
Measured: approximately 2 year
Secondary outcomes (9)
Plasma Concentration of 5-Fluorouracil
Measured: Pre-dose, 1 hour and after end of infusion on Day 1 Cycles 1-4
Plasma Concentration of Irinotecan
Measured: Pre-dose, 1 hour and after end of infusion on Day 1 Cycles 1-4
Number of Participants With Anti-MEHD7945A Antibodies
Measured: 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
Measured: approximately 2 year
Duration of Objective Response According to Modified RECIST v1.1 Criteria
Measured: approximately 2 year
Overall Survival (OS)
Measured: approximately 2 year
Number of Participants With Adverse Events
Measured: approximately 2 year
Maximum Observed Serum Concentration (Cmax) of MEHD7945A
Measured: 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
Measured: Pre-dose on Day 1 Cycles 1-4, Cycle 8 and at treatment completion (up to approximately 2 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652482
- Sponsor's protocol ID
- GO28074
- Other IDs
- 2011-005547-27
- Status last verified
- Nov 2016
- First submitted
- 26 Jul 2012
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
Hill AG, Findlay MP, Burge ME, Jackson C, Alfonso PG, Samuel L, Ganju V, Karthaus M, Amatu A, Jeffery M, Bartolomeo MD, Bridgewater J, Coveler AL, Hidalgo M, Kapp AV, Sufan RI, McCall BB, Hanley WD, Penuel EM, Pirzkall A, Tabernero J. Phase II Study of the Dual EGFR/HER3 Inhibitor Duligotuzumab (MEHD7945A) versus Cetuximab in Combination with FOLFIRI in Second-Line RAS Wild-Type Metastatic Colorectal Cancer. Clin Cancer Res. 2018 May 15;24(10):2276-2284. doi: 10.1158/1078-0432.CCR-17-0646. Epub 2018 Mar 5.
PubMed 29506988
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01652482
- Acronym / sponsor ID
- GO28074
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 30 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLFIRI + Cetuximab | Active comparator | Drug: 5-fluorouracil, Drug: Cetuximab, Drug: Irinotecan, Drug: Leucovorin |
| FOLFIRI + MEHD7945A | Experimental | Drug: 5-fluorouracil, Drug: Irinotecan, Drug: Leucovorin, Drug: MEHD7945A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-fluorouracilAlso: ADRUCILStandard 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. | Drug | FOLFIRI + Cetuximab, FOLFIRI + MEHD7945A |
| CetuximabAlso: ErbituxCetuximab 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. | Drug | FOLFIRI + Cetuximab |
| IrinotecanAlso: CAMPTOSARStandard 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. | Drug | FOLFIRI + Cetuximab, FOLFIRI + MEHD7945A |
| LeucovorinAlso: WELLCOVORINStandard 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. | Drug | FOLFIRI + Cetuximab, FOLFIRI + MEHD7945A |
| MEHD7945AMEHD7945A 1100 milligram (mg) intravenous infusion every 2 weeks until documented disease progression or unacceptable toxicity. | Drug | FOLFIRI + MEHD7945A |
Primary outcome
Progression-free Survival (PFS) According to Modified RECIST v1.1 Criteria
Time frame: approximately 2 year
9 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Derived from this study: PubMed 29506988Hill AG, Findlay MP, Burge ME, Jackson C, Alfonso PG, Samuel L, Ganju V, Karthaus M, Amatu A, Jeffery M, Bartolomeo MD, Bridgewater J, Coveler AL, Hidalgo M, Kapp AV, Sufan RI, McCall BB, Hanley WD, Penuel EM, Pirzkall A, Tabernero J. Phase II Study of the Dual EGFR/HER3 Inhibitor Duligotuzumab (MEHD7945A) versus Cetuximab in Combination with FOLFIRI in Second-Line RAS Wild-Type Metastatic Colorectal Cancer. Clin Cancer Res. 2018 May 15;24(10):2276-2284. doi: 10.1158/1078-0432.CCR-17-0646. Epub 2018 Mar 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
65 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5-fluorouracil, Cetuximab and Irinotecan in people with Colorectal Cancer, run by Genentech, Inc. at 65 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States, Australia, Belgium, Germany, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) According to Modified RECIST v1.1 Criteria (time frame: approximately 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01652482, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.