Trial Outcomes & Findings for Eribulin Mesylate Administered in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Alone as First-Line Therapy for Locally Advanced or Metastatic Bladder Cancer (NCT NCT01126749)

Last Updated: 2022-02-28

Results Overview

DLTs were clinically significant adverse events within 21 days of treatment judged by investigator at least possibly related to treatment. This included greater than or equal to (\>=) Grade 3 (G3) peripheral neuropathy, \>=G3 nausea and vomiting despite optimal anti-emetic treatment, any other non-hematologic toxicity of \>=G3 (except alopecia, single abnormal laboratory values the Investigator judged unlikely related to study therapy, had no clinical correlate, and resolved within 7 days, and hypersensitivity reaction to any of the 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 or without nontraumatic bleeding), any study drug-related death, any other toxicity the dose escalation committee believed to be DLT.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

92 participants

Primary outcome timeframe

Cycle 1 (Cycle length=21 days)

Results posted on

2022-02-28

Participant Flow

Participants took part in the study at 32 investigative sites in Germany, Netherlands, Spain, Ukraine, United Kingdom and the United States from 16 April 2010 to 20 July 2016.

A total of 92 participants were enrolled in this study. This study consisted of two phases: Phase 1b and Phase 2. In Phase 1b, 9 participants were enrolled and received study treatment and in Phase 2, 83 participants were randomized, of which 80 participants received the study treatment.

Participant milestones

Participant milestones
Measure	Phase 1b: Eribulin Mesylate 0.7 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 Participants received Eribulin Mesylate 0.7 milligram per square meter (mg/m\^2), as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of a 21-day cycle until the occurrence of disease progression (PD), unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.	Phase 1b: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 Participants received Eribulin Mesylate 1.0 mg/m\^2, as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of a 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.	Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 Participants received Eribulin Mesylate 1.0 mg/m\^2 (Recommended Phase 2 dose), as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.	Phase 2: Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 Participants received Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
Phase 1b STARTED	3	6	0	0
Phase 1b COMPLETED	0	0	0	0
Phase 1b NOT COMPLETED	3	6	0	0
Phase 2 STARTED	0	0	42	41
Phase 2 Safety Analysis Set (SAS)/Treated	0	0	41	39
Phase 2 Modified-intent-to-treat (MITT)	0	0	40	39
Phase 2 COMPLETED	0	0	0	0
Phase 2 NOT COMPLETED	0	0	42	41

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1b: Eribulin Mesylate 0.7 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 Participants received Eribulin Mesylate 0.7 milligram per square meter (mg/m\^2), as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of a 21-day cycle until the occurrence of disease progression (PD), unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.	Phase 1b: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 Participants received Eribulin Mesylate 1.0 mg/m\^2, as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of a 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.	Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 Participants received Eribulin Mesylate 1.0 mg/m\^2 (Recommended Phase 2 dose), as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.	Phase 2: Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 Participants received Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
Phase 1b Other	0	1	0	0
Phase 1b Withdrawal by Subject	0	1	0	0
Phase 1b Death	3	4	0	0
Phase 2 Completed 1 Year Follow-Up Per Protocol	0	0	4	7
Phase 2 Study Termination by Sponsor	0	0	12	6
Phase 2 Other	0	0	4	2
Phase 2 Withdrawal by Subject	0	0	0	2
Phase 2 Lost to Follow-up	0	0	0	1
Phase 2 Death	0	0	22	22
Phase 2 Adverse Event	0	0	0	1

Baseline Characteristics

Eribulin Mesylate Administered in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Alone as First-Line Therapy for Locally Advanced or Metastatic Bladder Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1b: Eribulin Mesylate 0.7 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 n=3 Participants Participants received Eribulin Mesylate 0.7 mg/m\^2, as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of a 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.	Phase 1b: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 n=6 Participants Participants received Eribulin Mesylate 1.0 mg/m\^2, as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of a 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.	Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 n=41 Participants Participants received Eribulin Mesylate 1.0 mg/m\^2 (Recommended Phase 2 dose), as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.	Phase 2: Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 n=39 Participants Participants received Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.	Total n=89 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	4 Participants n=7 Participants	15 Participants n=5 Participants	14 Participants n=4 Participants	35 Participants n=21 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	26 Participants n=5 Participants	25 Participants n=4 Participants	54 Participants n=21 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants	14 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	5 Participants n=7 Participants	36 Participants n=5 Participants	32 Participants n=4 Participants	75 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	8 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	39 Participants n=5 Participants	34 Participants n=4 Participants	79 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	6 Participants n=7 Participants	41 Participants n=5 Participants	39 Participants n=4 Participants	89 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: Cycle 1 (Cycle length=21 days)

Population: SAS included all participants who were randomized and treated in Phase 1b of this study.

Outcome measures

Outcome measures
Measure	Phase 1b: Eribulin Mesylate 0.7 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 n=3 Participants Participants received Eribulin Mesylate 0.7 mg/m\^2, as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of a 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.	Phase 1b: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 n=6 Participants Participants received Eribulin Mesylate 1.0 mg/m\^2, as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of a 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
Phase 1b: Number of Participants With Dose-limiting Toxicity (DLT) as Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug up to approximately 6 years 3 months

Population: SAS included all participants who were randomized and treated in Phase 2 of this study.

TEAE was 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 were 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 was any untoward medical occurrence that at any dose: resulted in death; life threatening required inpatient hospitalization; resulted in persistent, significant disability; was congenital anomaly/birth defect or medically important due to other reasons than mentioned criteria. Number of participants with TEAEs and SAEs were reported.

Outcome measures

Outcome measures
Measure	Phase 1b: Eribulin Mesylate 0.7 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 n=41 Participants Participants received Eribulin Mesylate 0.7 mg/m\^2, as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of a 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.	Phase 1b: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 n=39 Participants Participants received Eribulin Mesylate 1.0 mg/m\^2, as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of a 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAEs	41 Participants	38 Participants
Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAEs	22 Participants	14 Participants

SECONDARY outcome

Timeframe: From the date of randomization until the earlier of the following two events: the date of PD or the date of death (Up to approximately 6 years 3 months)

Population: 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. Due to the lack of a clear definition for PFS censoring rules and deviation from the statistical analysis plan relating to interim analyses, the PFS analysis was deemed unreliable and therefore data was not collected and reported.

PFS was defined as the time from the date of randomization until the earlier of the following two events: the date of disease progression (PD) or the date of death based on response evaluation criteria in solid tumor (RECIST) version (v) 1.1. PD was 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of randomization until CR or PR (Up to approximately 6 years 3 months)

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

Overall response rate was defined as the percentage of participants with the best confirmed response of complete response (CR) or partial response (PR) based on RECIST v1.1. CR was 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 was 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.

Outcome measures

Outcome measures
Measure	Phase 1b: Eribulin Mesylate 0.7 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 n=40 Participants Participants received Eribulin Mesylate 0.7 mg/m\^2, as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of a 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.	Phase 1b: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 n=39 Participants Participants received Eribulin Mesylate 1.0 mg/m\^2, as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of a 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
Phase 2: Percentage of Participants With Overall Response	52.5 percentage of participants Interval 37.0 to 68.0	46.2 percentage of participants Interval 30.5 to 61.8

SECONDARY outcome

Timeframe: Week 12

Population: MITT analysis set included all participants who were randomized and received at least one dose of study medication without major protocol eligibility violations. Due to the lack of a clear definition for PFS censoring rules and deviation from the statistical analysis plan relating to interim analyses, the PFS analysis was deemed unreliable and therefore data was not collected and reported.

PFS was defined as the time from the date of randomization until the earlier of the following two events: the date of PD or the date of death based on RECIST v1.1. 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of randomization until the date of PD (Up to approximately 6 years 3 months)

TTP was defined as the time from the date of randomization until the date of PD based on RECIST v1.1. PD was 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of randomization until the date of death (Up to approximately 6 years 3 months)

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

OS was defined as the time from the date of randomization until the date of death due to any cause.

Outcome measures

Outcome measures
Measure	Phase 1b: Eribulin Mesylate 0.7 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 n=40 Participants Participants received Eribulin Mesylate 0.7 mg/m\^2, as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of a 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.	Phase 1b: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 n=39 Participants Participants received Eribulin Mesylate 1.0 mg/m\^2, as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of a 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
Phase 2: Overall Survival (OS)	62.9 weeks Interval 39.86 to 132.0	64.6 weeks Interval 50.43 to 126.4

Adverse Events

Phase 1b: Eribulin Mesylate 0.7 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 3 deaths

Phase 1b: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2

Serious events: 1 serious events

Other events: 6 other events

Deaths: 4 deaths

Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2

Serious events: 22 serious events

Other events: 41 other events

Deaths: 22 deaths

Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2

Serious events: 14 serious events

Other events: 38 other events

Deaths: 22 deaths

Serious adverse events

Other adverse events

Additional Information

Eisai Medical Information

Eisai Inc.

Phone: +1-888-274-2378

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place