Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016015-37 | EudraCT Number |
Not provided
Not provided
Not provided
The study was terminated early as the combination of E7820 and FOLFIRI was deemed to be not tolerable, hence no efficacy analysis was conducted.
Not provided
| Name | Class |
|---|---|
| Quintiles, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| FOLFIRI plus Bevacizumab | Experimental | Bevacizumab at 5 mg/kg (IV infusion) on Days 1 and 15 of each 28-day treatment cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOLFIRI | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Patients may be entered in the study only if they meet all of the following criteria:
Exclusion Criteria:
Patients will not be entered in the study for any of the following reasons:
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| Name | Affiliation | Role |
|---|---|---|
| Harish Dave | Quintiles, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Cancer Center - Midtown | Denver | Colorado | 80218 | United States | ||
| Summit Medical Group |
A total of 5 participants were enrolled and treated in Phase 1b part of the study and only safety was analyzed for all participants in this study. The planned dose escalation of E7820 at 70 milligram per day (mg/day), 100 mg/day and Phase 2 part were not conducted as the study was terminated early without determination of the Maximum Tolerated Dose (MTD) as the combination of E7820 plus FOLFIRI (irinotecan, leucovorin, and 5-fluorouracil [5-FU]) was deemed to be not tolerable.
Participants took part in the study at 4 investigative sites in Australia and the United States from 04 March 2010 to 18 February 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1b: E7820 40 mg/Day + FOLFIRI | Participants received E7820 40 mg/day tablets orally, in combination with a FOLFIRI regimen on Days 1 to 2 and 15 to 16 of each 28-day treatment cycle. FOLFIRI regimen consisted of; Irinotecan 180 milligram per square meter (mg/m^2), Leucovorin 200 mg/m^2 administered by intravenous (IV) infusion on Days 1 and 15 of each 28-day treatment cycle, and 400 mg/m^2 5-fluorouracil (5-FU) administered as an IV bolus injection followed by a total of 2400 mg/m^2 5-FU administered by continuous IV (CIV) infusion over 46 hours on Days 1 to 2, then repeated on Days 15 to 16 of each 28-day treatment cycle. Participants continued to receive study treatment unless there was occurrence of progressive disease (PD), unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, or death, whichever occurred first. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase 1b (Dose Escalation Phase) |
|
Not provided
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Not provided
Not provided
Not provided
Not provided
|
|
| E7820 | Drug | E7820 will be administered orally in tablet form once daily, every day of each 28-day treatment cycle. |
|
| Bevacizumab | Drug | Bevacizumab will be administered at 5 mg/kg (IV infusion) on Days 1 and 15 of each 28-day treatment cycle. |
|
|
Physical examination included examination of the head, eyes, ears, nose, throat, neck, heart, chest, lungs, abdomen, extremities, skin, lymph nodes, and neurological status.
| 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. | From date of first dose up to 30 days after last dose of study treatment (up to 11.5 months) |
| 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. | 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. | 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. | From date of randomization to date of PD or death, up to 11 months |
| Berkeley Heights |
| New Jersey |
| 07922 |
| United States |
| Hematology Oncology Associates SJ P.A. | Mount Holly | New Jersey | 08060 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75246 | United States |
| Northwest Medical Specialties, PLLC | Tacoma | Washington | 98405 | United States |
| North Coast Cancer Institute | Coffs Harbour | New South Wales | 2450 | Australia |
| Sydney Haematology & Oncology Clinic | Hornsby | New South Wales | 2077 | Australia |
| Calvary Mater Newcastle | Waratah | New South Wales | 2298 | Australia |
| Royal Brisbane and Women's Hospital | Herston | Queensland | 4029 | Australia |
| Royal Hobart Hospital | Hobart | South Australia | 7000 | Australia |
| Queen Elizabeth Hospital | Woodville South | South Australia | 5011 | Australia |
| Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| The Austin Hospital | Epping | Victoria | 3076 | Australia |
| Newcastle Private Hospital | Merewether | 2305 | Australia |
| Jawaharlal Nehru Cancer Hospital and Research Centre | Bhopal | Madhya Pradesh | 462001 | India |
| Searoc Cancer Hosptial | Jaipur | Rajasthan | 302013 | India |
| Gujarat Cancer & Research Institute | Ahmedabad | 380016 | India |
| Kidwai Institute of Oncology | Bangalore | 560029 | India |
| M. S. Ramaiah Memorial Hospital | Bangalore | 560054 | India |
| Subodh Mitra Cancer Hospital and Research centre | Kolkata | 700106 | India |
| Shatabdi Hospital | Nashik | 422005 | India |
| Deenanath Mangeshkar Hospital and Research Center | Pune | 411004 | India |
| Noble Hospital | Pune | 411013 | India |
| Christian Medical College | Vellore | 632002 | India |
| CCH #2 n.a. N. A. Semashko of LLC "Russian Railways" | Moscow | 129128 | Russia |
| City Mariinskaya Hospital | Saint Petersburg | 191104 | Russia |
| Scientific Research Oncology Institute named after N.N. Petr | Saint Petersburg | 197758 | Russia |
| Yaroslav Regional Clinical Oncology Hospital | Yaroslav | 150054 | Russia |
| Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU | Dnipropetrovsk | 49102 | Ukraine |
| Donetsk Regional Anticancer Centre | Donetsk | 83092 | Ukraine |
| City Clinical Hospital #2 | Kharkiv | 61001 | Ukraine |
| The St.Inst. "S.P.Grigoriev Med. Rad.Inst. of AMS of Ukr." | Kharkiv | 61024 | Ukraine |
| Uzhgorod Centr.City Cl.Hosp.,City Onc.Center, UNMU,Fac.of PG | Uzhhorod | 88000 | Ukraine |
| FG001 | Phase 1b: E7820 70 mg/Day + FOLFIRI | Participants were planned to receive E7820 70 mg/day tablets orally, in combination with a FOLFIRI regimen on Days 1 to 2 and 15 to 16 of each 28-day treatment cycle. FOLFIRI regimen consisted of; Irinotecan 180 mg/m^2, Leucovorin 200 mg/m^2 administered by IV infusion on Days 1 and 15 of each 28-day treatment cycle, and 400 mg/m^2 5-FU administered as an IV bolus injection followed by a total of 2400 mg/m^2 5-FU administered by CIV infusion over 46 hours on Days 1 to 2, then repeated on Days 15 to 16 of each 28-day treatment cycle. Participants were planned to receive study treatment unless there was occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, or death, whichever occurred first. No participants were enrolled in this arm. The study did not progress beyond Phase 1b (E7820 40 mg/day). |
| FG002 | Phase 1b: E7820 100 mg/Day + FOLFIRI | Participants were planned to receive E7820 100 mg/day tablets orally, in combination with a FOLFIRI regimen on Days 1 to 2 and 15 to 16 of each 28-day treatment cycle. FOLFIRI regimen consisted of; Irinotecan 180 mg/m^2, Leucovorin 200 mg/m^2 administered by IV infusion on Days 1 and 15 of each 28-day treatment cycle, and 400 mg/m^2 5-FU administered as an IV bolus injection followed by a total of 2400 mg/m^2 5-FU administered by CIV infusion over 46 hours on Days 1 to 2, then repeated on Days 15 to 16 of each 28-day treatment cycle. Participants were planned to receive study treatment unless there was occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, or death, whichever occurred first. No participants were enrolled in this arm. The study did not progress beyond Phase 1b (E7820 40 mg/day). |
| FG003 | Phase 2: FOLFIRI | Participants were planned to receive FOLFIRI regimen consisted of; Irinotecan 180 mg/m^2, Leucovorin 200 mg/m^2 administered by IV infusion on Days 1 and 15 of each 28-day treatment cycle, and 400 mg/m^2 5-FU administered as an IV bolus injection followed by a total of 2400 mg/m^2 5-FU administered by CIV infusion over 46 hours on Days 1 to 2, then repeated on Days 15 to 16 of each 28-day treatment cycle. Participants were planned to receive study treatment unless there was occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, or death, whichever occurred first. No participants were enrolled in this arm. The study did not progress beyond Phase 1b (E7820 40 mg/day). |
| FG004 | Phase 2: FOLFIRI + Bevacizumab | Participants were planned to receive FOLFIRI regimen consisted of; Irinotecan 180 mg/m^2, Leucovorin 200 mg/m^2 administered by IV infusion on Days 1 and 15 of each 28-day treatment cycle, and 400 mg/m^2 5-FU administered as an IV bolus injection followed by a total of 2400 mg/m^2 5-FU administered by CIV infusion over 46 hours on Days 1 to 2, then repeated on Days 15 to 16 of each 28-day treatment cycle followed by Bevacizumab 5 mg/kg, IV infusion on Days 1 and 15 of each 28-day treatment cycle. Participants were planned to receive study treatment unless there was occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, or death, whichever occurred first. No participants were enrolled in this arm. The study did not progress beyond Phase 1b (E7820 40 mg/day). |
| FG005 | Phase 2: E7820 (RP2D) + FOLFIRI | Participants were planned to receive E7820 70 mg/day tablets orally, in combination with a FOLFIRI regimen on Days 1 to 2 and 15 to 16 of each 28-day treatment cycle. FOLFIRI regimen consisted of; Irinotecan 180 mg/m^2, Leucovorin 200 mg/m^2 administered by IV infusion on Days 1 and 15 of each 28-day treatment cycle, and 400 mg/m^2 5-FU administered as an IV bolus injection followed by a total of 2400 mg/m^2 5-FU administered by CIV infusion over 46 hours on Days 1 to 2, then repeated on Days 15 to 16 of each 28-day treatment cycle. Participants were planned to receive study treatment unless there was occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, or death, whichever occurred first. No participants were enrolled in this arm. The study did not progress beyond Phase 1b (E7820 40 mg/day). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Phase 2 (Dose-confirmation Phase) |
|
Safety population included all participants who received at least one dose of study drug and who had safety assessment post the first dose.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1b: E7820 40 mg/Day + FOLFIRI | Participants received E7820 40 mg/day tablets orally, in combination with a FOLFIRI regimen on Days 1 to 2 and 15 to 16 of each 28-day treatment cycle. FOLFIRI regimen consisted of; Irinotecan 180 mg/m^2, Leucovorin 200 mg/m^2 administered by IV infusion on Days 1 and 15 of each 28-day treatment cycle, and 400 mg/m^2 5 -FU administered as an IV bolus injection followed by a total of 2400 mg/m^2 5-FU administered by CIV infusion over 46 hours on Days 1 to 2, then repeated on Days 15 to 16 of each 28-day treatment cycle. Participants continued to receive study treatment unless there was occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, or death, whichever occurred first. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Safety population included all participants who received at least one dose of study drug and who had safety assessment post the first dose. | Posted | Count of Participants | Participants | Cycle 1 (each cycle length=28 days) |
|
|
| ||||||||||||||||||||||||||
| Primary | 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. | Safety population included all participants who received at least one dose of study drug and who had safety assessment post the first dose. | Posted | Count of Participants | Participants | From date of first dose up to 30 days after last dose of study treatment (up to 11.5 months) |
| ||||||||||||||||||||||||||||
| Primary | 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. | Safety population included all participants who received at least one dose of study drug and who had safety assessment post the first dose. | Posted | Count of Participants | Participants | From date of first dose up to 30 days after last dose of study treatment (up to 11.5 months) |
| ||||||||||||||||||||||||||||
| Primary | 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. | Safety population included all participants who received at least one dose of study drug and who had safety assessment post the first dose. | Posted | Count of Participants | Participants | From date of first dose up to 30 days after last dose of study treatment (up to 11.5 months) |
|
| |||||||||||||||||||||||||||
| Primary | 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. | Safety population included all participants who received at least one dose of study drug and who had safety assessment post the first dose. | Posted | Count of Participants | Participants | From date of first dose up to 30 days after last dose of study treatment (up to 11.5 months) |
|
| |||||||||||||||||||||||||||
| Secondary | 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. | The study was terminated before the initiation of Phase 2, so the data for this outcome measure was not collected and analyzed. | Posted | From the date of randomization to date of PD or death (whichever occurred first), up to 11 months |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | The study was terminated before the initiation of Phase 2, so the data for this outcome measure was not collected and analyzed. | Posted | From date randomization to date of PD or death, up to 11 months |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | The study was terminated before the initiation of Phase 2, so the data for this outcome measure was not collected and analyzed. | Posted | From date of treatment start to until date of first PD or death (whichever occurred first), up to 11 months |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | The study was terminated before the initiation of Phase 2, so the data for this outcome measure was not collected and analyzed. | Posted | From date of randomization to date of PD or death, up to 11 months |
|
Phase 1b: From date of first dose up to 30 days after last dose of study treatment (up to 11.5 months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1b: E7820 40 mg/Day + FOLFIRI | Participants received E7820 40 mg/day tablets orally, in combination with a FOLFIRI regimen on Days 1 to 2 and 15 to 16 of each 28-day treatment cycle. FOLFIRI regimen consisted of; Irinotecan 180 mg/m^2, Leucovorin 200 mg/m^2 administered by IV infusion on Days 1 and 15 of each 28-day treatment cycle, and 400 mg/m^2 5 -FU administered as an IV bolus injection followed by a total of 2400 mg/m^2 5-FU administered by CIV infusion over 46 hours on Days 1 to 2, then repeated on Days 15 to 16 of each 28-day treatment cycle. Participants continued to receive study treatment unless there was occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, or death, whichever occurred first. | 2 | 5 | 2 | 5 | 5 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | MedDRA version 13.1 | Systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA version 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 13.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 13.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA version 13.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA version 13.1 | Systematic Assessment |
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| Oesophagitis | Gastrointestinal disorders | MedDRA version 13.1 | Systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA version 13.1 | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA version 13.1 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA version 13.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 13.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA version 13.1 | Systematic Assessment |
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| Swelling face | Skin and subcutaneous tissue disorders | MedDRA version 13.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA version 13.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 13.1 | Systematic Assessment |
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| Venous occlusion | Vascular disorders | MedDRA version 13.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 13.1 | Systematic Assessment |
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| Vulvovaginal candidiasis | Infections and infestations | MedDRA version 13.1 | Systematic Assessment |
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The study was terminated early as the combination of E7820 and FOLFIRI was deemed to be not tolerable, hence no efficacy analysis was conducted.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Information | Eisai Inc. | 1-888-274-2378 | esi_oncmedinfo@eisai.com |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C480833 | IFL protocol |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| D000077146 | Irinotecan |
| C468872 | N-(3-cyano-4-methyl-1H-indol-7-yl)-3-cyanobenzene-sulfonamide |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
| Participants |
|
|
| Phase 2: FOLFIRI + Bevacizumab |
Participants were planned to receive FOLFIRI regimen consisted of; Irinotecan 180 mg/m^2, Leucovorin 200 mg/m^2 administered by IV infusion on Days 1 and 15 of each 28-day treatment cycle, and 400 mg/m^2 5-FU administered as an IV bolus injection followed by a total of 2400 mg/m^2 5-FU administered by CIV infusion over 46 hours on Days 1 to 2, then repeated on Days 15 to 16 of each 28-day treatment cycle followed by Bevacizumab 5 mg/kg, IV infusion on Days 1 and 15 of each 28-day treatment cycle. Participants were planned to receive study treatment unless there was occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, or death, whichever occurred first. No participants were enrolled in this arm. The study did not progress beyond Phase 1b (E7820 40 mg/day). |
| OG002 | Phase 2: E7820 (RP2D) + FOLFIRI | Participants were planned to receive E7820 70 mg/day tablets orally, in combination with a FOLFIRI regimen on Days 1 to 2 and 15 to 16 of each 28-day treatment cycle. FOLFIRI regimen consisted of; Irinotecan 180 mg/m^2, Leucovorin 200 mg/m^2 administered by IV infusion on Days 1 and 15 of each 28-day treatment cycle, and 400 mg/m^2 5-FU administered as an IV bolus injection followed by a total of 2400 mg/m^2 5-FU administered by CIV infusion over 46 hours on Days 1 to 2, then repeated on Days 15 to 16 of each 28-day treatment cycle. Participants were planned to receive study treatment unless there was occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, or death, whichever occurred first. No participants were enrolled in this arm. The study did not progress beyond Phase 1b (E7820 40 mg/day). |
|
Participants were planned to receive FOLFIRI regimen consisted of; Irinotecan 180 mg/m^2, Leucovorin 200 mg/m^2 administered by IV infusion on Days 1 and 15 of each 28-day treatment cycle, and 400 mg/m^2 5-FU administered as an IV bolus injection followed by a total of 2400 mg/m^2 5-FU administered by CIV infusion over 46 hours on Days 1 to 2, then repeated on Days 15 to 16 of each 28-day treatment cycle followed by Bevacizumab 5 mg/kg, IV infusion on Days 1 and 15 of each 28-day treatment cycle. Participants were planned to receive study treatment unless there was occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, or death, whichever occurred first. No participants were enrolled in this arm. The study did not progress beyond Phase 1b (E7820 40 mg/day).
| OG002 | Phase 2: E7820 (RP2D) + FOLFIRI | Participants were planned to receive E7820 70 mg/day tablets orally, in combination with a FOLFIRI regimen on Days 1 to 2 and 15 to 16 of each 28-day treatment cycle. FOLFIRI regimen consisted of; Irinotecan 180 mg/m^2, Leucovorin 200 mg/m^2 administered by IV infusion on Days 1 and 15 of each 28-day treatment cycle, and 400 mg/m^2 5-FU administered as an IV bolus injection followed by a total of 2400 mg/m^2 5-FU administered by CIV infusion over 46 hours on Days 1 to 2, then repeated on Days 15 to 16 of each 28-day treatment cycle. Participants were planned to receive study treatment unless there was occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, or death, whichever occurred first. No participants were enrolled in this arm. The study did not progress beyond Phase 1b (E7820 40 mg/day). |
|
| OG001 | Phase 2: FOLFIRI + Bevacizumab | Participants were planned to receive FOLFIRI regimen consisted of; Irinotecan 180 mg/m^2, Leucovorin 200 mg/m^2 administered by IV infusion on Days 1 and 15 of each 28-day treatment cycle, and 400 mg/m^2 5-FU administered as an IV bolus injection followed by a total of 2400 mg/m^2 5-FU administered by CIV infusion over 46 hours on Days 1 to 2, then repeated on Days 15 to 16 of each 28-day treatment cycle followed by Bevacizumab 5 mg/kg, IV infusion on Days 1 and 15 of each 28-day treatment cycle. Participants were planned to receive study treatment unless there was occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, or death, whichever occurred first. No participants were enrolled in this arm. The study did not progress beyond Phase 1b (E7820 40 mg/day). |
| OG002 | Phase 2: E7820 (RP2D) + FOLFIRI | Participants were planned to receive E7820 70 mg/day tablets orally, in combination with a FOLFIRI regimen on Days 1 to 2 and 15 to 16 of each 28-day treatment cycle. FOLFIRI regimen consisted of; Irinotecan 180 mg/m^2, Leucovorin 200 mg/m^2 administered by IV infusion on Days 1 and 15 of each 28-day treatment cycle, and 400 mg/m^2 5-FU administered as an IV bolus injection followed by a total of 2400 mg/m^2 5-FU administered by CIV infusion over 46 hours on Days 1 to 2, then repeated on Days 15 to 16 of each 28-day treatment cycle. Participants were planned to receive study treatment unless there was occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, or death, whichever occurred first. No participants were enrolled in this arm. The study did not progress beyond Phase 1b (E7820 40 mg/day). |
|
| OG002 | Phase 2: E7820 (RP2D) + FOLFIRI | Participants were planned to receive E7820 70 mg/day tablets orally, in combination with a FOLFIRI regimen on Days 1 to 2 and 15 to 16 of each 28-day treatment cycle. FOLFIRI regimen consisted of; Irinotecan 180 mg/m^2, Leucovorin 200 mg/m^2 administered by IV infusion on Days 1 and 15 of each 28-day treatment cycle, and 400 mg/m^2 5-FU administered as an IV bolus injection followed by a total of 2400 mg/m^2 5-FU administered by CIV infusion over 46 hours on Days 1 to 2, then repeated on Days 15 to 16 of each 28-day treatment cycle. Participants were planned to receive study treatment unless there was occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, or death, whichever occurred first. No participants were enrolled in this arm. The study did not progress beyond Phase 1b (E7820 40 mg/day). |
|