Colorectal CancerPhase 1/2NCT01133990
FOLFIRI Alone Versus FOLFIRI Plus Bevacizumab Versus FOLFIRI Plus E7820 as Second-Line Therapy in Patients With Locally Advanced or Metastatic Colorectal Cancer
A Phase 1/2 study testing FOLFIRI, E7820 and Bevacizumab in people with Colorectal Cancer, run by Eisai Inc. at 34 sites in 5 countries.
Trial summary
The purpose of the Phase Ib portion is to find out the highest dose of study drug that can safely be given when tested in a small group of subjects. The purpose of the Phase II portion is to find out how safe the study drug is when taken at the highest dose in a larger group of subjects. 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?
- FOLFIRI, E7820 and Bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 34 sitesin 5 countries
- Study dates
- 4 Mar 2010to 18 Feb 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients may be entered in the study only if they meet all of the following criteria:
- Male or female patient greater than or equal to 18 years of age;
- Histologically or cytologically confirmed nonresectable locally advanced or metastatic colorectal adenocarcinoma;
- Patients must have failed a first-line chemotherapy regimen for nonresectable locally advanced or mCRC (first-line bevacizumab is allowed). Patients randomized to the Phase Ib portion can have up to 3 total prior regimens (including adjuvant therapy in addition to treatment for advanced disease);
- At least 1 site of measurable disease by the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) criteria;
- Life expectancy of > 3 months;
Show all 15Show fewer
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1;
- Patients must have adequate renal function as evidenced by serum creatinine <2 mg/dL and creatinine clearance >50 mL/minute per the Cockcroft and Gault formula;
- Patients must have adequate bone marrow function as evidenced by absolute neutrophil count (ANC) >1.5 x 109/L, platelets >100 x 109/L, hemoglobin >9.0 g/dL (a hemoglobin <9.0 g/dL at Screening is acceptable if it is corrected to >9 g/dL by growth factor or transfusion prior to first dose);
- Patients must have adequate liver function as evidenced by bilirubin <1.5 times the upper limit of the normal range (ULN), and alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) <3 X ULN (in the case of liver metastases, <5 X ULN). If there are bone metastases, liver-specific alkaline phosphatase may be separated from the total and used to assess liver function instead of total alkaline phosphatase;
- Blood pressure must be well-controlled (<140/90 mmHg at screening) with or without antihypertensive medication. Patients must have no history of hypertensive crisis or hypertensive encephalopathy;
- Male or female patients of child-producing potential must agree to use double barrier contraception, oral contraceptives, or avoidance of pregnancy measures during the study and for 90 days after the last day of treatment;
- Females of childbearing potential must have a negative serum pregnancy test;
- Females may not be breastfeeding; and
- Ability to understand and willingness to sign a written consent.
Who cannot join
- Patients will not be entered in the study for any of the following reasons:
- Received chemotherapy, targeted therapy, radiotherapy, surgery, immunotherapy, or treatment in another clinical study within the 30 days prior to commencing study treatment or have not recovered from side effects of all treatment-related toxicities to Grade <1, except for peripheral neuropathy (Grade 1 and Grade 2 are permitted) and alopecia;
- Previously received irinotecan or irinotecan derivatives;
- Previously received anti-alpha 2 integrin therapy;
- History of other malignancies except: (1) adequately treated basal or squamous cell carcinoma of the skin; (2) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (3) other curatively treated solid tumor with no evidence of disease for >5 years;
- Presence of brain metastases, unless the patient has received adequate treatment at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 4 weeks prior to randomization;
Show all 22Show fewer
- Are currently receiving any other anticancer treatment;
- Palliative radiotherapy is not permitted throughout the study period;
- Serious non-healing wound, ulcer, or active bone fracture;
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for a major surgical procedure during the course of the study;
- Refractory nausea and vomiting, malabsorption, significant bowel resection, or any other medical condition that would preclude adequate absorption or result in the inability to take oral medication;
- Significant cardiovascular impairment (history of congestive heart failure New York Heart Association [NYHA] Grade >2, unstable angina or myocardial infarction within the past 6 months, or serious cardiac arrhythmia);
- Active hemoptysis (defined as bright red blood of
- Current or recent use (within 7 days) of full-dose warfarin (except low-dose warfarin as required to maintain patency of preexisting, permanent indwelling IV catheters). For subjects receiving warfarin, International Normalization Ratio (INR) should be <1.5. Patients may have prophylactic use of low molecular weight heparin, however therapeutic use of heparin or low molecular weight heparin is not acceptable;
- History of bleeding diathesis or coagulopathy;
- Any history of cerebral vascular accident, transient ischemic attack or ≥ Grade 2 peripheral vascular disease, unless they have had no evidence of active disease for at least 6 months prior to randomization;
- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1, unless affected area has been removed surgically;
- Patients with organ allografts requiring immunosuppression;
- Known positive human immunodeficiency virus (HIV), known hepatitis B surface antigen, or active hepatitis C positive;
- Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab, irinotecan, 5-FU, or leucovorin;
- Hypersensitivity to sulfonamide derivatives; or
- Have any medical condition that would interfere with the conduct of the study.
Trial locations and contacts
34 sites in 5 countries.
34 sites in 5 countries
India10 sites
Gujarat Cancer & Research Institute
Ahmedabad, 380016
Kidwai Institute of Oncology
Bangalore, 560029
M. S. Ramaiah Memorial Hospital
Bangalore, 560054
Jawaharlal Nehru Cancer Hospital and Research Centre
Bhopal, Madhya Pradesh, 462001
Searoc Cancer Hosptial
Jaipur, Rajasthan, 302013
Subodh Mitra Cancer Hospital and Research centre
Kolkata, 700106
Shatabdi Hospital
Nashik, 422005
Deenanath Mangeshkar Hospital and Research Center
Pune, 411004
Noble Hospital
Pune, 411013
Christian Medical College
Vellore, 632002
Australia9 sites
Box Hill Hospital
Box Hill, Victoria, 3128
North Coast Cancer Institute
Coffs Harbour, New South Wales, 2450
The Austin Hospital
Epping, Victoria, 3076
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Royal Hobart Hospital
Hobart, South Australia, 7000
Sydney Haematology & Oncology Clinic
Hornsby, New South Wales, 2077
Newcastle Private Hospital
Merewether, 2305
Calvary Mater Newcastle
Waratah, New South Wales, 2298
Queen Elizabeth Hospital
Woodville South, South Australia, 5011
United States6 sites
Summit Medical Group
Berkeley Heights, New Jersey, 07922
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
University of Texas Southwestern Medical Center
Dallas, Texas, 75246
Rocky Mountain Cancer Center - Midtown
Denver, Colorado, 80218
Hematology Oncology Associates SJ P.A.
Mount Holly, New Jersey, 08060
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405
Ukraine5 sites
Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU
Dnipropetrovsk, 49102
Donetsk Regional Anticancer Centre
Donetsk, 83092
City Clinical Hospital #2
Kharkiv, 61001
The St.Inst. "S.P.Grigoriev Med. Rad.Inst. of AMS of Ukr."
Kharkiv, 61024
Uzhgorod Centr.City Cl.Hosp.,City Onc.Center, UNMU,Fac.of PG
Uzhhorod, 88000
Russia4 sites
CCH #2 n.a. N. A. Semashko of LLC "Russian Railways"
Moscow, 129128
City Mariinskaya Hospital
Saint Petersburg, 191104
Scientific Research Oncology Institute named after N.N. Petr
Saint Petersburg, 197758
Yaroslav Regional Clinical Oncology Hospital
Yaroslav, 150054
About this study
Official title: An Open-Label, Multicenter, Randomized Phase Ib/II Study of FOLFIRI Alone Versus FOLFIRI Plus Bevacizumab Versus FOLFIRI Plus E7820 as Second-Line Therapy in Patients With Locally Advanced or Metastatic Colorectal Cancer
The purpose of the Phase Ib portion is to find out the highest dose of study drug that can safely be given when tested in a small group of subjects.
The purpose of the Phase II portion is to find out how safe the study drug is when taken at the highest dose in a larger group of subjects.
Read the detailed description
The primary purpose for Phase 1b: to determine the maximum tolerated dose (MTD) of E7820 recommended for Phase 2 when administered in combination with the FOLFIRI regimen (irinotecan, leucovorin, and 5-fluorouracil [5-FU]) in participants with locally advanced or metastatic colorectal cancer (mCRC) who have failed first-line therapy. Phase 2: to evaluate the safety and tolerability of E7820 administered in combination with the FOLFIRI regimen, compared with FOLFIRI alone and FOLFIRI plus bevacizumab, in patients with locally advanced or mCRC who have failed first-line therapy.
- Conditions
- Colorectal Cancer
- Being tested
- FOLFIRI, E7820, Bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFIRIDrug
Also called leucovorin calcium (calcium folinate), 5-fluorouracil, and irinotecan
FOLFIRI will be administered as IV infusion on Days 1 and 15 of each cycle, and 5-FU at 400 mg/m^2 as an IV bolus injection followed by a total of 2400 mg/m2 by CIV infusion over 46 hours over Days 1 and 2 via an ambulatory programmable pump. The 5-FU IV bolus (400 mg/m^2) and CIV infusion (2400 mg/m^2) over 46 hours is repeated on Days 15 and 16 of each cycle.
E7820Drug
E7820 will be administered orally in tablet form once daily, every day of each 28-day treatment cycle.
BevacizumabDrug
Also called Avastin
Bevacizumab will be administered at 5 mg/kg (IV infusion) on Days 1 and 15 of each 28-day treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| FOLFIRI | Active comparator | The FOLFIRI regimen consists of irinotecan at 180 mg/m2 (IV infusion) on Day 1 and Day 15 of each 28-day cycle, leucovorin at 200 mg/m2 (400 mg/m2 if using d,l-racemic mixture of leucovorin) by IV infusion on Days 1 and 15 of each cycle, and 5-FU at 400 mg/m2 as an IV bolus injection followed by a total of 2400 mg/m2 by CIV infusion over 46 hours over Days 1 and 2 via an ambulatory programmable pump (the use of an ambulatory pump is optional). The 5-FU IV bolus (400 mg/m2) and CIV infusion (2400 mg/m2) over 46 hours is repeated on Days 15 and 16 of each cycle. Receives: Drug: FOLFIRI |
| E7820 | Experimental | E7820 is administered orally in tablet form once daily, every day of each 28-day treatment cycle. For the Phase Ib portion, the doses will be 40 mg/day, 70 mg/day, and 100 mg/day, and for the Phase II portion, the dose will be the MTD recommended Phase IB dose in combination with FOLFIRI, as determined during the Phase Ib portion of the study. Receives: Drug: FOLFIRI; Drug: E7820 |
| FOLFIRI plus Bevacizumab | Experimental | Bevacizumab at 5 mg/kg (IV infusion) on Days 1 and 15 of each 28-day treatment cycle Receives: Drug: FOLFIRI; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs)
Dose-limiting toxicities were defined as clinically significant adverse events (AEs) occurring less than or equal to (<=) 28 days after commencing study treatment and considered by the investigator to be possibly or probably related to study treatment. Toxicity was evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v.4.0).
Measured: Cycle 1 (each cycle length=28 days)
Phase 1b: Number of Participants With Any Treatment-emergent Adverse Events (TEAEs)
Adverse Events were defined as TEAEs if they started on or after the date and time of administration of the first dose of study drug during the study. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. Any change in hematology, clinical chemistry, urine values and regular measurement of vital signs which were deemed clinically significant by the investigator were recorded as TEAE.
Measured: From date of first dose up to 30 days after last dose of study treatment (up to 11.5 months)
Phase 1b: Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
ECOG-PS measured participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than[ >] 50 percent [%] of waking hours), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hours; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead.
Measured: From date of first dose up to 30 days after last dose of study treatment (up to 11.5 months)
Phase 1b: Number of Participants With Clinically Significant Changes in Physical Examinations
Physical examination included examination of the head, eyes, ears, nose, throat, neck, heart, chest, lungs, abdomen, extremities, skin, lymph nodes, and neurological status.
Measured: From date of first dose up to 30 days after last dose of study treatment (up to 11.5 months)
Phase 1b: Number of Participants With Clinically Significant Change From Baseline in Electrocardiograms (ECGs) Parameter
ECG was to be a complete standardized 12-lead recording. The ECGs were reviewed by the investigator or designee prior to study drug administration as part of the participant's standard of care.
Measured: From date of first dose up to 30 days after last dose of study treatment (up to 11.5 months)
Secondary outcomes (4)
Phase 2: Progression-Free Survival (PFS)
PFS was defined as the time from the date of randomization of a participant to the date of first documentation of PD or death (whichever occurred first) based on investigator assessments according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. PD was defined as at least a 20% increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions.
Measured: From the date of randomization to date of PD or death (whichever occurred first), up to 11 months
Phase 2: Time to Progression (TTP)
TTP was defined as time from the date of randomization of a participant until the date of first documented progression of such participant's disease based on investigator assessments according to RECIST v.1.1. PD was defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions.
Measured: From date randomization to date of PD or death, up to 11 months
Phase 2: Objective Response Rate (ORR)
ORR was defined as percentage of participants in the study whose best overall response was either CR or PR based on investigator assessments according to RECIST v1.1. A confirmatory scan was required after no less than 4 weeks and no later than 8 weeks, starting on the date that the response was first recorded. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (<)10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From date of treatment start to until date of first PD or death (whichever occurred first), up to 11 months
Phase 2: Overall Survival (OS)
OS was defined as time from the date of randomization of a participant until the date of death of such participant, regardless of the actual cause of the participant's death.
Measured: From date of randomization to date of PD or death, up to 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study start4 Mar 2010
- Primary completion18 Feb 2011
- Study completion18 Feb 2011
Why it stopped: The study was terminated early as the combination of E7820 and FOLFIRI was deemed to be not tolerable, hence no efficacy analysis was conducted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Eisai 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- Harish Dave, Study director, Quintiles, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133990
- Sponsor's protocol ID
- E7820-701
- Other IDs
- 2009-016015-37, 2009
- Status last verified
- Jul 2012
- First submitted
- 21 May 2010
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Randomized Phase Ib/II Study of FOLFIRI Alone Versus FOLFIRI Plus Bevacizumab Versus FOLFIRI Plus E7820 as Second-Line Therapy in Patients With Locally Advanced or Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01133990
- Acronym / sponsor ID
- E7820-701
- Conditions
- Colorectal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early as the combination of E7820 and FOLFIRI was deemed to be not tolerable, hence no efficacy analysis was conducted.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- 4 Mar 2010 (actual)
- Primary completion
- 18 Feb 2011 (actual)
- Study completion
- 18 Feb 2011 (actual)
- First posted
- 31 May 2010 (estimated)
- Results
- Posted 7 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the Phase Ib portion is to find out the highest dose of study drug that can safely be given when tested in a small group of subjects.
The purpose of the Phase II portion is to find out how safe the study drug is when taken at the highest dose in a larger group of subjects.
Detailed description
The primary purpose for Phase 1b: to determine the maximum tolerated dose (MTD) of E7820 recommended for Phase 2 when administered in combination with the FOLFIRI regimen (irinotecan, leucovorin, and 5-fluorouracil [5-FU]) in participants with locally advanced or metastatic colorectal cancer (mCRC) who have failed first-line therapy. Phase 2: to evaluate the safety and tolerability of E7820 administered in combination with the FOLFIRI regimen, compared with FOLFIRI alone and FOLFIRI plus bevacizumab, in patients with locally advanced or mCRC who have failed first-line therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FOLFIRI | Active comparator | Drug: FOLFIRIThe FOLFIRI regimen consists of irinotecan at 180 mg/m2 (IV infusion) on Day 1 and Day 15 of each 28-day cycle, leucovorin at 200 mg/m2 (400 mg/m2 if using d,l-racemic mixture of leucovorin) by IV infusion on Days 1 and 15 of each cycle, and 5-FU at 400 mg/m2 as an IV bolus injection followed by a total of 2400 mg/m2 by CIV infusion over 46 hours over Days 1 and 2 via an ambulatory programmable pump (the use of an ambulatory pump is optional). The 5-FU IV bolus (400 mg/m2) and CIV infusion (2400 mg/m2) over 46 hours is repeated on Days 15 and 16 of each cycle. |
| E7820 | Experimental | Drug: FOLFIRI, Drug: E7820E7820 is administered orally in tablet form once daily, every day of each 28-day treatment cycle. For the Phase Ib portion, the doses will be 40 mg/day, 70 mg/day, and 100 mg/day, and for the Phase II portion, the dose will be the MTD recommended Phase IB dose in combination with FOLFIRI, as determined during the Phase Ib portion of the study. |
| FOLFIRI plus Bevacizumab | Experimental | Drug: FOLFIRI, Drug: BevacizumabBevacizumab at 5 mg/kg (IV infusion) on Days 1 and 15 of each 28-day treatment cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female patient greater than or equal to 18 years of age;
- Histologically or cytologically confirmed nonresectable locally advanced or metastatic colorectal adenocarcinoma;
- Patients must have failed a first-line chemotherapy regimen for nonresectable locally advanced or mCRC (first-line bevacizumab is allowed). Patients randomized to the Phase Ib portion can have up to 3 total prior regimens (including adjuvant therapy in addition to treatment for advanced disease);
- At least 1 site of measurable disease by the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) criteria;
- Life expectancy of > 3 months;
Key exclusion criteria (22 listed)
- Received chemotherapy, targeted therapy, radiotherapy, surgery, immunotherapy, or treatment in another clinical study within the 30 days prior to commencing study treatment or have not recovered from side effects of all treatment-related toxicities to Grade <1, except for peripheral neuropathy (Grade 1 and Grade 2 are permitted) and alopecia;
- Previously received irinotecan or irinotecan derivatives;
- Previously received anti-alpha 2 integrin therapy;
- History of other malignancies except: (1) adequately treated basal or squamous cell carcinoma of the skin; (2) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (3) other curatively treated solid tumor with no evidence of disease for >5 years;
- Presence of brain metastases, unless the patient has received adequate treatment at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 4 weeks prior to randomization;
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 |
|---|---|---|
| FOLFIRIAlso: leucovorin calcium (calcium folinate), 5-fluorouracil, and irinotecanFOLFIRI will be administered as IV infusion on Days 1 and 15 of each cycle, and 5-FU at 400 mg/m^2 as an IV bolus injection followed by a total of 2400 mg/m2 by CIV infusion over 46 hours over Days 1 and 2 via an ambulatory programmable pump. The 5-FU IV bolus (400 mg/m^2) and CIV infusion (2400 mg/m^2) over 46 hours is repeated on Days 15 and 16 of each cycle. | Drug | E7820, FOLFIRI, FOLFIRI plus Bevacizumab |
| E7820E7820 will be administered orally in tablet form once daily, every day of each 28-day treatment cycle. | Drug | E7820 |
| BevacizumabAlso: AvastinBevacizumab will be administered at 5 mg/kg (IV infusion) on Days 1 and 15 of each 28-day treatment cycle. | Drug | FOLFIRI plus Bevacizumab |
Primary outcome
Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs)
Time frame: Cycle 1 (each cycle length=28 days)
Dose-limiting toxicities were defined as clinically significant adverse events (AEs) occurring less than or equal to (<=) 28 days after commencing study treatment and considered by the investigator to be possibly or probably related to study treatment. Toxicity was evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v.4.0).
Phase 1b: Number of Participants With Any Treatment-emergent Adverse Events (TEAEs)
Time frame: From date of first dose up to 30 days after last dose of study treatment (up to 11.5 months)
Adverse Events were defined as TEAEs if they started on or after the date and time of administration of the first dose of study drug during the study. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. Any change in hematology, clinical chemistry, urine values and regular measurement of vital signs which were deemed clinically significant by the investigator were recorded as TEAE.
Phase 1b: Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Time frame: From date of first dose up to 30 days after last dose of study treatment (up to 11.5 months)
ECOG-PS measured participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than[ >] 50 percent [%] of waking hours), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hours; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead.
Phase 1b: Number of Participants With Clinically Significant Changes in Physical Examinations
Time frame: From date of first dose up to 30 days after last dose of study treatment (up to 11.5 months)
Physical examination included examination of the head, eyes, ears, nose, throat, neck, heart, chest, lungs, abdomen, extremities, skin, lymph nodes, and neurological status.
Phase 1b: Number of Participants With Clinically Significant Change From Baseline in Electrocardiograms (ECGs) Parameter
Time frame: From date of first dose up to 30 days after last dose of study treatment (up to 11.5 months)
ECG was to be a complete standardized 12-lead recording. The ECGs were reviewed by the investigator or designee prior to study drug administration as part of the participant's standard of care.
4 secondary outcomes
Phase 2: Progression-Free Survival (PFS)
Time frame: From the date of randomization to date of PD or death (whichever occurred first), up to 11 months
Phase 2: Time to Progression (TTP)
Time frame: From date randomization to date of PD or death, up to 11 months
Phase 2: Objective Response Rate (ORR)
Time frame: From date of treatment start to until date of first PD or death (whichever occurred first), up to 11 months
Phase 2: Overall Survival (OS)
Time frame: From date of randomization to date of PD or death, up to 11 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Harish Dave study director
Quintiles, Inc.
34 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FOLFIRI, E7820 and Bevacizumab in people with Colorectal Cancer, run by Eisai Inc. at 34 sites in 5 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 15 inclusion and 22 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: stopped early, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in India, Australia, United States, Ukraine, Russia. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 7 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) (time frame: Cycle 1 (each cycle length=28 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2023.