Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Bone Density Conservation Agents

Hematinics

Vitamins

Irinotecan

Bevacizumab

Leucovorin

Fluorouracil

Levoleucovorin

Calcium

Calcium, Dietary

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Hormones

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

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 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.

Bevacizumab at 5 mg/kg (IV infusion) on Days 1 and 15 of each 28-day treatment cycle

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.

FOLFIRI

E7820 will be administered orally in tablet form once daily, every day of each 28-day treatment cycle.

E7820

Bevacizumab will be administered at 5 mg/kg (IV infusion) on Days 1 and 15 of each 28-day treatment cycle.

Harish Dave

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.

FOLFIRI Alone Versus FOLFIRI Plus Bevacizumab Versus FOLFIRI Plus E7820 as Second-Line Therapy in Patients With Locally Advanced or Metastatic Colorectal Cancer

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

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).

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.

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.

Physical examination included examination of the head, eyes, ears, nose, throat, neck, heart, chest, lungs, abdomen, extremities, skin, lymph nodes, and neurological status.

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.

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.

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.

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.

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.

Quintiles, Inc.

Eisai Inc.

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.

Phase 1b: E7820 40 mg/Day + FOLFIRI

43 - 83 years

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Safety population included all participants who received at least one dose of study drug and who had safety assessment post the first dose.

The study was terminated early as the combination of E7820 and FOLFIRI was deemed to be not tolerable, hence no efficacy analysis was conducted.

Eisai Medical Information

Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs)

Phase 1b: Number of Participants With Any Treatment-emergent Adverse Events (TEAEs)

Participants With ECOG-PS Grade 1

Participants With ECOG-PS Grade 2

Participants With ECOG-PS Grade 3

Participants With ECOG-PS Grade 4

Participants With ECOG-PS Grade 5

Phase 1b: Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG-PS)

Phase 1b: Number of Participants With Clinically Significant Changes in Physical Examinations

Phase 1b: Number of Participants With Clinically Significant Change From Baseline in Electrocardiograms (ECGs) Parameter

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).

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 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).

Phase 2: FOLFIRI + Bevacizumab

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).

Phase 2: E7820 (RP2D) + FOLFIRI

The study was terminated before the initiation of Phase 2, so the data for this outcome measure was not collected and analyzed.

Phase 2: Progression-Free Survival (PFS)

Phase 2: Time to Progression (TTP)

Phase 2: Objective Response Rate (ORR)

Phase 2: Overall Survival (OS)

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.

Phase 1b: E7820 70 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).

Phase 1b: E7820 100 mg/Day + FOLFIRI

Phase 1b (Dose Escalation Phase)

Phase 2 (Dose-confirmation Phase)

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Jantien Wanders, M.D.

This is a first-in-man, open-label, non-randomized, multiple dose, multiple cycle, dose escalation study to determine the MTD, safety, PK, and pharmacodynamics of E7820 in patients with a malignant solid tumor or lymphoma.

Dosing and Safety Study of E7820 in Patients With a Malignant Solid Tumor or Lymphoma

Phase I and Pharmacokinetic Study of E7820 After Oral Administration to Patients With Malignancy

Rectal Neoplasms

Herbal and Botanical

Cola

Comparator dose and mode of administration The FOLFIRI regimen consists of irinotecan at 180 mg/m2 (IV infusion) on Day 1 of each 14-day cycle, leucovorin at 200 mg/m2 (400 mg/m2 if using d,l-racemic mixture of leucovorin) by IV infusion on Day 1 of each cycle, and 5-FU at 400 mg/m2 as an IV bolus injection followed by a total of 2400 mg/m2 by continuous IV infusion over 46 hours over Days 1 and 2 via an ambulatory programmable pump (the use of an ambulatory pump is optional).

Test product: dose and mode of administration:

E7820 is administered orally in tablet form once daily, every day of each 14-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 Pase II portion, the dose will be the MTD in combination with Irinotecan, as determined during the Phase ib portion of the study.

The irinotecan regimen consists of an irinotecan dose of 180 mg/m2 by IV infusion once every 2 weeks (Day 1 of each 14-day cycle).

This open-label, multicenter, randomized study will consist of a Phase Ib portion: a safety run-in period with 3 ascending doses of E7820; and a Phase II portion: a randomized 2-arm design. Approximately 95 patients with measurable, nonresectable locally advanced or metastatic colorectal adenocarcinoma, who have failed first-line chemotherapy, will be enrolled in the study (approximately 12 to 15 patients in the Phase Ib portion and 80 patients in the Phase II portion). Patients will only participate in either the Phase Ib or the Phase II portion of the study. Patients will receive up to a planned total of 12 cycles of study treatment unless there is occurrence of progressive disease, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurs first. After 12 cycles, patients who demonstrate clinical benefit may continue single agent E7820 for long as clinical benefit is sustained and the treatment is well tolerated. If the treating physician does not feel comfortable discontinuing chemotherapy after 12 cycles, further chemotherapy may be considered following discussion with the medical monitor and sponsor.

Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer

An Open-Label, Multicenter, Randomized Phase Ib/II Study of Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer

MTD: maximum dose that was determined to be safe and tolerable for Phase 2.If two dose limiting toxicities (DLTs) occurred at any dose level,MTD: preceding dose/intermediate dose.DLT was graded according to CTCAE v4.0. Includes \>= Grade 3(G3) peripheral neuropathy,\>=G3 nausea/vomiting despite optimal anti-emetic treatment, any other non-hematologic toxicity of \>=G3(except alopecia, single abnormal laboratory values Investigator judged unlikely related to study therapy, had no clinical correlate, resolved in 7 days, hypersensitivity reaction to any of compounds),Grade 4 neutropenia lasting over 7 days,febrile neutropenia(defined as fever \>=38.5 degrees Celsius with absolute neutrophil count below 1.0\*10\^9 per liter, G3 thrombocytopenia with nontraumatic bleeding(without therapeutic systemic anticoagulation)requiring platelet transfusion,Grade 4 thrombocytopenia (with/without nontraumatic bleeding),any study drug-related death,other toxicity dose escalation committee believed to be DLT.

TEAE is defined as an adverse event that had an onset date, or a worsening in severity on or after the first dose of study drug up to the end of the study. Number of participants with TEAEs are reported based on safety assessments of laboratory tests, physical examination, examining bowel movements, regular measurement of vital signs, eastern cooperative oncology group-performance status and electrocardiogram parameter values. SAE is any untoward medical occurrence that at any dose: resulted in death; life threatening required inpatient hospitalization; resulted in persistent, significant disability; is congenital anomaly/birth defect or medically important due to other reasons than above mentioned criteria. Number of participants with TEAEs and SAEs were reported.

PFS is defined as the time from the date of randomization of a participant until the sooner of (1) the date of first documented progression of such participant's disease (PD) based on Investigator assessments according to response evaluation criteria in solid tumor (RECIST) version (v) 1.1. or; (2) the date of such participant's death due to any cause. PD is defined as at least a 20 percent (%) 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.

OS is 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.

TTP is defined as time from the date of randomization of a participant until the date of first documented progression of such participant's disease. PD is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking in reference the smallest summed longest diameters on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of 1 or more new lesions was also considered progression.

ORR is defined as percentage of participants in the study whose best overall response is either complete response (CR) or partial response (PR) based on RECIST v1.1. CR is defined as complete disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to less than 10 mm. PR is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline summed longest diameters.

PharmaBio Development Inc.

Participants received E7820 40 mg tablets, orally, once daily of each 14-day treatment cycle in combination with irinotecan 180 milligram per square meter (mg/m\^2) as an intravenous infusion on Day 1 of each 14-day cycle (once every 2 weeks) for up to 12 cycles. After 12 cycles, at the discretion of the Investigator and in consultation with the Medical Monitor, participants who were experiencing clinical benefit continued their assigned treatment until PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.

Phase 1b: Cohort 1: E7820 40 mg + Irinotecan

Participants received E7820 70 mg tablets, orally, once daily of each 14-day treatment cycle in combination with irinotecan 180 mg/m\^2 as an intravenous infusion on Day 1 of each 14-day cycle (once every 2 weeks) for up to 12 cycles. After 12 cycles, at the discretion of the Investigator and in consultation with the Medical Monitor, participants who were experiencing clinical benefit continued their assigned treatment until PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.

Phase 1b: Cohort 2: E7820 70 mg + Irinotecan

Participants received E7820 100 mg tablets, orally, once daily of each 14-day treatment cycle in combination with irinotecan 180 mg/m\^2 as an intravenous infusion on Day 1 of each 14-day cycle (once every 2 weeks) for up to 12 cycles. After 12 cycles, at the discretion of the Investigator and in consultation with the Medical Monitor, participants who were experiencing clinical benefit continued their assigned treatment until PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.

Phase 1b: Cohort 3: E7820 100 mg + Irinotecan

Participants received E7820 70 mg (changed to 50 mg as per protocol amendment 06) as Recommended Phase 2 dose (RP2D) tablets, orally, once daily of each 14-day treatment cycle on Day 1 with Irinotecan 180 mg/m\^2 as an intravenous infusion on Day 1 of each 14-day cycle for up to 12 cycles. After 12 cycles, at the discretion of the Investigator and in consultation with the Medical Monitor, participants who were experiencing clinical benefit continued their assigned treatment until PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.

Phase 2: E7820 70 mg + Irinotecan

Participants received the FOLFIRI regimen, which consisted of irinotecan at 180 mg/m\^2 as an intravenous infusion and leucovorin at 200 mg/m\^2 by intravenous infusion on Day 1 of each cycle, and 5-FU at 400 mg/m\^2 as an intravenous bolus injection followed by a total of 2400 mg/m\^2 by continuous IV infusion over 46 hours over Days 1 and 2 via infusion for up to 12 cycles. After 12 cycles, at the discretion of the Investigator and in consultation with the Medical Monitor, participants who were experiencing clinical benefit continued their assigned treatment until PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.

Phase 2: Folfiri

Total

The safety population included all the participants who received at least one dose of study drug and who had at least one safety assessment following the first dose.

Participants received E7820 40 mg, 70 mg and 100 mg tablets, orally, once daily of each 14-day treatment cycle in combination with irinotecan 180 mg/m\^2 as an intravenous infusion on Day 1 of each 14-day cycle (once every 2 weeks) for up to 12 cycles. After 12 cycles, at the discretion of the Investigator and in consultation with the Medical Monitor, participants who were experiencing clinical benefit continued their assigned treatment until PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.

Phase 1b, All Participants

The safety population included all the participants enrolled in the Phase 1b portion of this study, except for those who (i) dropped out of the study prior to receiving any study drug, or (ii) were without any safety assessment following the first dose of study drug.

Phase 1b: Maximum Tolerated Dose (MTD) of E7820 With Irinotecan as Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0

TEAEs

SAEs

The safety population included all participants enrolled and randomized to treatment in the Phase 2 portion of this study, except for those who (i) dropped out prior to receiving any study drug, or (ii) were without any safety assessment following the first dose of study drug.

Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Modified intent-to-treat (MITT) analysis set included all participants who were randomized and received at least one dose of study medication without major protocol eligibility violations.

Phase 2: Progression Free Survival (PFS)

MITT analysis set included all participants who were randomized and received at least one dose of study medication without major protocol eligibility violations.

Phase 2: Percentage of Participants With Overall Response

Participants received E7820 40 milligram (mg) tablets, orally, once daily of each 14-day treatment cycle in combination with irinotecan 180 milligram per square meter (mg/m\^2) as an intravenous infusion on Day 1 of each 14-day cycle (once every 2 weeks) for up to 12 cycles. After 12 cycles, at the discretion of the Investigator and in consultation with the Medical Monitor, participants who were experiencing clinical benefit continued their assigned treatment until disease progression (PD), unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
FOLFIRI Alone Versus FOLFIRI Plus Bevacizumab Versus FOLFIRI Plus E7820 as Second-Line Therapy in Patients With Locally Advanced or Metastatic Colorectal Cancer	NCT01133990	Colorectal Canc...	FOLFIRI E7820 Bevacizumab	18 Years -	Eisai Inc.
Dosing and Safety Study of E7820 in Patients With a Malignant Solid Tumor or Lymphoma	NCT00078637	Neoplasms Lymphoma, Malig...	E7820	18 Years -	Eisai Inc.
Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer	NCT01347645	Colon Cancer Rectal Cancer	FOLFIRI E7820	18 Years -	Eisai Inc.
FOLFIRI Alone Versus FOLFIRI Plus Bevacizumab Versus FOLFIRI Plus E7820 as Second-Line Therapy in Patients With Locally Advanced or Metastatic Colorectal Cancer	NCT01133990	Colorectal Canc...	FOLFIRI E7820 Bevacizumab	18 Years -	Eisai Inc.

Spots Global Cancer Trial Database for e7820

Every month we try and update this database with for e7820 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for e7820

Every month we try and update this database with for e7820 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for e7820 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.