Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| HSC20150891H | Other Identifier | University of Texas Health Science Center- San Antonio |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eisai Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The overall purpose of this study is to determine the overall response rate, efficacy and safety of the combination of eribulin and Lenvatinib.
This is a phase II clinical trial of the combination of eribulin, and Lenvatinib. A cycle will be defined as 21 days. Eribulin will be given on days 1 and 8 of each cycle. Lenvatinib will be given daily during each cycle.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Eribulin and lenvatinib | Experimental | Eribulin will be given on days 1 and 8. Lenvatinib will be given daily in each 28 day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eribulin | Drug | Will be given by I.V. at 1.4 mg/m2 on day 1 and day 8. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate of Lenvatinib and Eribulin (Phase II) | Defined as the percentage of patients with best overall response of complete response (CR) or partial response (PR) as assessed by independent imaging review. | The overall response rate will be assessed after two cycles of therapy (1 cycle = 3 weeks) until the date of first documentation of disease progression or death (whichever occurs first) over an average of 18 months. |
| Progression Free Survival | Progression-free survival (PFS) will be defined as the time from the first study treatment to the first occurrence of progression or death. | Baseline to 50 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival Rate | Baseline to 50 months | |
| Lenvatinib and Eribulin Toxicities Will be Graded Using NCI CTCAE Version 4.03 | Adverse events are graded in the NCI CTCAE version 4.03 scale and reported by number of adverse events per grade |
Not provided
Inclusion Criteria:
Leukocytes ≥ 3,000/uL Absolute neutrophil count ≥ 1,500/uL Platelets ≥ 100,000/uL Child Pugh score ≤ 10 Patients must be able to swallow and retain oral medication. All patients must have given signed, informed consent prior to registration on study.
Exclusion Criteria:
Women who are pregnant or lactating are not eligible for study treatment.
Patients who are undergoing concomitant radiotherapy are NOT eligible for participation.
Patients who are receiving any other investigational agents or concurrent anticancer therapy are NOT eligible for participation. Previous systemic treatment and/or radiation therapy is allowed with a 14 day washout period prior to registration.
Lesions that have been radiated previously cannot be considered target lesions
Prior treatment related side effects must have resolved to < Grade 2 severity per Common Terminology Criteria for Adverse Events (CTCAE version 4.03), except alopecia and infertility.
Patients who are taking any herbal (alternative) medicines are NOT eligible for participation. Patients must be off any such medications by the time of registration.
Patients with known brain metastases are NOT eligible for participation unless the brain metastases are treated (either with surgical excision, stereotactic radiosurgery or radiotherapy) and have been stable for at least 4 wks per MR performed, the patient is asymptomatic and has discontinued corticosteroids if taken for that purpose.
Patients with any of the following conditions or complications are NOT eligible for participation:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Virginia Kaklamani, MD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Therapy and Research Center University of Texas Health Science Center San Antonio | San Antonio | Texas | 78229 | United States |
A 10-patient safety run-in phase for each drug combination will be conducted during cycle 1 of the treatment and subjects evaluated with the remainder of subjects enrolled. After the first 10 subjects have been enrolled the phase II enrollment will begin with the aim of enrolling an additional 20 subjects. All surviving subjects who received study drug will be followed for disease progression and survival. Evaluation of the subjects will be conducted as a single group.
Participants with the following diagnoses will be included: metastatic solid tumors including breast cancer, NSCLC and soft-tissue sarcoma.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lenvatinib and Eribulin | Eribulin will be administered on cycle days 1 and 8; Lenvatinib is an orally administered medication given daily throughout each cycle. On days when both drugs are administered, Eribulin will be administered immediately prior to Lenvatinib. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Combination Eribulin and Lenvatinib | Eribulin will be given on days 1 and 8. Lenvatinib will be given daily in each 28 day cycle. Eribulin: Will be given by I.V. at 1.4 mg/m2 on day 1 and day 8. Lenvatinib: Will be taken orally at 20-24 mg daily in each 21 day cycle. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Overall Response Rate of Lenvatinib and Eribulin (Phase II) | Defined as the percentage of patients with best overall response of complete response (CR) or partial response (PR) as assessed by independent imaging review. | Only 23 patients had evaluable disease as 6 subjects came off study early prior to first assessment due to toxicities. | Posted | Number | participants | The overall response rate will be assessed after two cycles of therapy (1 cycle = 3 weeks) until the date of first documentation of disease progression or death (whichever occurs first) over an average of 18 months. |
|
Adverse events were collected for all subjects from first cycle of the administration of the study drug through the end of the active study follow-up of the study during treatment up to 50 months. No subjects were escalated to a higher dose due to toxicity concerns, so all participants received the same dose.
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 | Combination Eribulin and Lenvatinib | Eribulin will be given on days 1 and 8. Lenvatinib will be given daily in each 28 day cycle. For each cycle: Eribulin: Will be given by I.V. at 1.4 mg/m2 on day 1 and day 8 and Lenvatinib: Will be taken orally at 20-24 mg daily days 1-21 of each 28 day cycle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophil count decreased | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oral mucositis | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Virginia Kaklamani, MD | UT Health San Antonio | 210-450-3838 | kaklamani@uthscsa.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2018 | Sep 23, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C490954 | eribulin |
| C531958 | lenvatinib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lenvatinib | Drug | Will be taken orally at 20-24 mg daily in each 21 day cycle. |
|
|
| Safety will be evaluated from the time of registration until 30 days after last dose of treatment, resolution of the related AE or death up to 40 months. |
| Lost to Follow-up |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ECOG performance status | Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 life expectancy of greater than 12 weeks, and adequate hematologic, liver and renal function. 0 Fully active; no performance restrictions.
| Number | Percentage |
|
| Tumor history | Count of Participants | Participants |
|
|
|
| Primary | Progression Free Survival | Progression-free survival (PFS) will be defined as the time from the first study treatment to the first occurrence of progression or death. | Posted | Median | Full Range | months | Baseline to 50 months |
|
|
|
| Secondary | Overall Survival Rate | Posted | Median | Full Range | Months | Baseline to 50 months |
|
|
|
| Secondary | Lenvatinib and Eribulin Toxicities Will be Graded Using NCI CTCAE Version 4.03 | Adverse events are graded in the NCI CTCAE version 4.03 scale and reported by number of adverse events per grade | All subjects that received investigational product, including those from Phase 1 that were not included in the analysis of data | Posted | Number | Events | Safety will be evaluated from the time of registration until 30 days after last dose of treatment, resolution of the related AE or death up to 40 months. |
|
|
|
| 19 |
| 29 |
| 4 |
| 29 |
| 29 |
| 29 |
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Colonic perforation | Gastrointestinal disorders | Systematic Assessment |
|
| Dehydration | General disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Epistaxis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Myalgia | Nervous system disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Thromboembolic event | Blood and lymphatic system disorders | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Palmar-plantar erthrodysestesia syndrome | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Neutrophil count decrease | Blood and lymphatic system disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Decreased platelet count | Blood and lymphatic system disorders | Systematic Assessment |
|
| Decreased white blood cell count | Blood and lymphatic system disorders | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Alanine Amino transferase increased | Hepatobiliary disorders | Systematic Assessment |
|
| Alkaline Phosphatase increased | Hepatobiliary disorders | Systematic Assessment |
|
| Aspartate aminotransferase increased | Hepatobiliary disorders | Systematic Assessment |
|
| Increased bilirubin | Blood and lymphatic system disorders | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Dysgeusia | Gastrointestinal disorders | Systematic Assessment | Taste disorder |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Measurements |
|---|
|
| Grade 4 |
|
| Grade 5 |
|