SarcomaPhase 2NCT03810976
A Study of Eribulin With Gemcitabine in Patients With Advanced Liposarcoma or Leiomyosarcoma
A Phase 2 study testing Eribulin, gemcitabine in people with Sarcoma, run by Yonsei University at 1 site in South Korea.
Trial summary
The eribulin, a microtubule-dynamics inhibitor was approved for specific subtypes of STS. Eribulin demonstrated significantly better OS compared to dacarbazine in previously treated patients with liposarcoma and leiomyosarcoma and approved as standard treatment. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- Eribulin, gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Mar 2018to 30 May 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed advanced liposarcoma or leiomyosarcoma with 1-2 prior chemotherapy including anthracycline (unless contraindicated)
- ECOG performance status of 0-2
- Measurable or evaluable disease (RECIST 1.1.)
- Adequate laboratory findings
- Hb ≥ 9.0 g/dL
- Absolute neutrophil count ≥ 1000 /µL
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- Platelet ≥ 75,000/ µL
- Total Bilirubin: ≤ 1.5 × UNL (upper normal limit) (≤ 2 × UNL in patients with liver metastasis)
- Serum Creatinine: ≤1.5 X upper limit of normal (ULN) OR ≥ Creatinine Clearance 60 mL/min (Cockcroft-Gault) for patients with creatinine levels > 1.5 X institutional ULN
- AST(SGOT)/ALT(SGPT): ≤ 3.0 × UNL or ≤ 5.0 × UNL (in patients with liver metastasis)
- Alkaline Phosphatase : ≤ 3.0 × UNL or ≤ 5.0 × UNL (in patients with liver or bone metastasis)
- Prothrombin time and partial thromboplastin time : ≤1.5 X ULN
- Female patient of childbearing potential has a negative serum or urine pregnancy test within 72 hours prior
Who cannot join
- More than 3 prior cytotoxic agents
- Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study
- Uncontrolled or active CNS metastasis and/or carcinomatous meningitis
- Patient has known hypersensitivity to the components of study drugs or its analogs.
- Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
- Long QT Syndrome ≥480 ms
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- peripheral neuropathy ≥2 with previous treatment
- unstable cardiovascular disease
- Symptomatic interstitial lung disease (ILD) or presence of ILD on chest X-ray
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital, Yonsei University Health System
Seoul, 03722
About this study
Official title: Open-label, Phase II Trial of Eribulin in Combination With Gemcitabine in Previously Treated Patients With Advanced Liposarcoma or Leiomyosarcoma
The eribulin, a microtubule-dynamics inhibitor was approved for specific subtypes of STS. Eribulin demonstrated significantly better OS compared to dacarbazine in previously treated patients with liposarcoma and leiomyosarcoma and approved as standard treatment. However, the median progression free survival (PFS) and response rate (RR) was similar for both groups which remains modest outcome of 2.6 months of PFS and 4% of RR. Therefore, to improve antitumor activity, further combination strategy is strongly warranted. Based on the previous studies, investigators suggest phase II trial of eribulin and gemcitabine combination in previously treated patients with unresectable, advanced, or metastatic leiomyosarcoma or liposarcoma.
- Conditions
- Sarcoma
- Being tested
- Eribulin, gemcitabine
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eribulin, gemcitabineDrug
Elibulin 1.4mg/m2 Intravenous for 5minutes. Day 1\& Day 8 every 3 weeks Gemcitabine 1000mg/m2 intraveoust for 30 minutes, Day 1\& Day 8 every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| eribulin+gemcitabine | Experimental | The dose is 1.4 mg/m2 for 5 minutes intravenously. If necessary, the dose may be diluted in up to 100 mL of saline solution prior to intravenous administration. Gemcitabine doses 1000 mg/m2 intravenously for 30 minutes. After completion of the eribulin injection, intravenously inject gemcitabine. One cycle is 3 weeks, and the treatment is carried out on the 1st day and the 8th day for each cycle. Receives: Drug: Eribulin, gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
To evaluate antitumor efficacy of eribulin and gemcitabine combination
Measured: 12 weeks
Secondary outcomes (1)
adverse event
to evaluate safety
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start27 Mar 2018
- Primary completion30 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo Song Kim, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810976
- Sponsor's protocol ID
- 4-2017-0933
- Status last verified
- Jun 2022
- First submitted
- 16 Jan 2019
- Last updated
- 16 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Phase II Trial of Eribulin in Combination With Gemcitabine in Previously Treated Patients With Advanced Liposarcoma or Leiomyosarcoma
- ClinicalTrials.gov ID
- NCT03810976
- Acronym / sponsor ID
- 4-2017-0933
- Conditions
- Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 22 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The eribulin, a microtubule-dynamics inhibitor was approved for specific subtypes of STS. Eribulin demonstrated significantly better OS compared to dacarbazine in previously treated patients with liposarcoma and leiomyosarcoma and approved as standard treatment. However, the median progression free survival (PFS) and response rate (RR) was similar for both groups which remains modest outcome of 2.6 months of PFS and 4% of RR. Therefore, to improve antitumor activity, further combination strategy is strongly warranted. Based on the previous studies, investigators suggest phase II trial of eribulin and gemcitabine combination in previously treated patients with unresectable, advanced, or metastatic leiomyosarcoma or liposarcoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eribulin+gemcitabine | Experimental | Drug: Eribulin, gemcitabineThe dose is 1.4 mg/m2 for 5 minutes intravenously. If necessary, the dose may be diluted in up to 100 mL of saline solution prior to intravenous administration. Gemcitabine doses 1000 mg/m2 intravenously for 30 minutes. After completion of the eribulin injection, intravenously inject gemcitabine. One cycle is 3 weeks, and the treatment is carried out on the 1st day and the 8th day for each cycle. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed advanced liposarcoma or leiomyosarcoma with 1-2 prior chemotherapy including anthracycline (unless contraindicated)
- ECOG performance status of 0-2
- Measurable or evaluable disease (RECIST 1.1.)
- Adequate laboratory findings
- Female patient of childbearing potential has a negative serum or urine pregnancy test within 72 hours prior
Key exclusion criteria (9 listed)
- More than 3 prior cytotoxic agents
- Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study
- Uncontrolled or active CNS metastasis and/or carcinomatous meningitis
- Patient has known hypersensitivity to the components of study drugs or its analogs.
- Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eribulin, gemcitabineElibulin 1.4mg/m2 Intravenous for 5minutes. Day 1\& Day 8 every 3 weeks Gemcitabine 1000mg/m2 intraveoust for 30 minutes, Day 1\& Day 8 every 3 weeks | Drug | eribulin+gemcitabine |
Primary outcome
progression free survival
Time frame: 12 weeks
To evaluate antitumor efficacy of eribulin and gemcitabine combination
1 secondary outcome
adverse event
Time frame: through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eribulin, gemcitabine in people with Sarcoma, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.