Trial Outcomes & Findings for Lenvatinib and Eribulin in Advanced Soft Tissue Sarcoma (NCT NCT03526679)

Results Overview

We will measure the radiographic changes of the tumor based on a prespecified criteria called RECIST (Response evaluation criteria in solid tumors). A tumor decreased in the sum of longest diameters of measurable tumors of more than 30% is considered responsive; a growth of tumor more than 20% in the sum of the longest diameter is considered disease progression; and shrinkage or growth between these intervals is considered stable disease (SD).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

30 participants

Primary outcome timeframe

24 weeks

Results posted on

2025-12-05

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental arm The combination of lenvatinib and eribulin Eribulin: lenvatinib 14mg po daily; eribulin 1.1mg/m2 D1, D8, every 21 days Lenvatinib: lenvatinib 14mg po daily; eribulin 1.1mg/m2 D1, D8, every 21 days
Overall Study STARTED	30
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental arm The combination of lenvatinib and eribulin Eribulin: lenvatinib 14mg po daily; eribulin 1.1mg/m2 D1, D8, every 21 days Lenvatinib: lenvatinib 14mg po daily; eribulin 1.1mg/m2 D1, D8, every 21 days
Overall Study still under treatment	2

Baseline Characteristics

Lenvatinib and Eribulin in Advanced Soft Tissue Sarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Arm n=30 Participants The combination of lenvatinib and eribulin Eribulin: lenvatinib 14mg po daily; eribulin 1.1mg/m2 D1, D8, every 21 days Lenvatinib: lenvatinib 14mg po daily; eribulin 1.1mg/m2 D1, D8, every 21 days
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=37 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=37 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	30 Participants n=37 Participants
Region of Enrollment Taiwan	30 participants n=37 Participants
Age, Categorical <=18 years	0 Participants n=37 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=37 Participants
Age, Categorical >=65 years	5 Participants n=37 Participants
Age, Continuous	59 years n=37 Participants
Sex: Female, Male Female	20 Participants n=37 Participants
Sex: Female, Male Male	10 Participants n=37 Participants

PRIMARY outcome

Timeframe: 24 weeks

We will measure the radiographic changes of the tumor based on a prespecified criteria called RECIST (Response evaluation criteria in solid tumors). A tumor decreased in the sum of longest diameters of measurable tumors of more than 30% is considered responsive; a growth of tumor more than 20% in the sum of the longest diameter is considered disease progression; and shrinkage or growth between these intervals is considered stable disease (SD).

Outcome measures

Outcome measures
Measure	Experimental arm n=30 Participants The combination of lenvatinib and eribulin Eribulin: lenvatinib 14mg po daily; eribulin 1.1mg/m2 D1, D8, every 21 days Lenvatinib: lenvatinib 14mg po daily; eribulin 1.1mg/m2 D1, D8, every 21 days
The Objective Response Rate (ORR) Based on RECIST 1.1	6 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: IIT population

We will measure how many patients (proportion) of the participants that the tumor has progressed in the first 24 weeks of treatment

Outcome measures

Outcome measures
Measure	Experimental arm n=30 Participants The combination of lenvatinib and eribulin Eribulin: lenvatinib 14mg po daily; eribulin 1.1mg/m2 D1, D8, every 21 days Lenvatinib: lenvatinib 14mg po daily; eribulin 1.1mg/m2 D1, D8, every 21 days
The Proportion of Patients Who Are Progression-free and Alive at 24 Weeks	30 Participants

SECONDARY outcome

Timeframe: 12 months

The definition of 12-months OS rate is the percentage of patients who had NOT has an event before or at 12 months. An event is defined as follows: Death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

The definition of 6 months OS rate is the percentage of patients who had NOT has an event before or at 6 months. An event is defined as follows: Death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Toxicities will be assessed according to CTCAE 4.03. The number of all grade toxicities will be recorded

Outcome measures

Outcome data not reported

Adverse Events

Experimental arm

Serious events: 20 serious events

Other events: 22 other events

Deaths: 12 deaths

Serious adverse events

Serious adverse events
Measure	Experimental arm n=30 participants at risk The combination of lenvatinib and eribulin Eribulin: lenvatinib 14mg po daily; eribulin 1.1mg/m2 D1, D8, every 21 days Lenvatinib: lenvatinib 14mg po daily; eribulin 1.1mg/m2 D1, D8, every 21 days
Skin and subcutaneous tissue disorders Hand-foot syndrome	16.7% 5/30 • 1 years
Vascular disorders Hypertension	13.3% 4/30 • 1 years
Blood and lymphatic system disorders neutrophil decrease	36.7% 11/30 • 1 years

Other adverse events

Other adverse events
Measure	Experimental arm n=30 participants at risk The combination of lenvatinib and eribulin Eribulin: lenvatinib 14mg po daily; eribulin 1.1mg/m2 D1, D8, every 21 days Lenvatinib: lenvatinib 14mg po daily; eribulin 1.1mg/m2 D1, D8, every 21 days
Skin and subcutaneous tissue disorders Hand-foot syndrome	73.3% 22/30 • 1 years

Additional Information

Dr. Tom Wei-Wu Chen

National Taiwan University Hospital

Phone: +886-2-23123456

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place