Solid TumorPhase 1NCT04013217
Evaluate Eribulin ORA in Subjects With Solid Tumors
A Phase 1 study testing Eribulin ORA in people with Solid Tumor, run by Health Hope Pharma at 1 site in United States.
Trial summary
This is a nonrandomized, open-label, dosed escalation, safety activity, and PK study to determine the MTD and optimal dosing regimen of Eribulin ORA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Eribulin ORA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2019to 2 Mar 2022
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and sign an informed consent form (ICF)
- Male and female adults, ≥18 years of age
- Histologically or cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; subjects enrolling in the dose expansion cohort must have breast cancer or liposarcoma.
- Must have at least one measurable site of disease as defined as per RECIST v1.1 criteria (dose expansion) or evaluable disease (dose escalation only)
- Eastern Cooperative Oncology Group (ECOG)2 Performance Status ≤1
- Adequate hematologic status as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) to maintain:
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- Absolute neutrophil count (ANC) ≥1.5 x 109/L
- Platelet count ≥100 x 109/L
- Hemoglobin ≥9.0 g/dL
- Adequate liver function as demonstrated by:
- Total and direct bilirubin within normal range
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 upper limit of normal (ULN)
- Gamma-glutamyl transferase (GGT) ≤5 x ULN
- Alkaline phosphatase ≤3 x ULN or ≤5 x ULN if bone or liver metastasis is present
- Serum creatinine ≤1.5 x ULN, or estimated creatinine clearance ≥50 mL/min according to the Cockcroft-Gault equation
- Prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) ≤1.5 x ULN OR if a subject is receiving anticoagulant therapy and PT or PTT is within therapeutic range of intended use of coagulants for 7 days prior to receiving study treatment
- Subjects receiving warfarin who are otherwise eligible and who may be appropriately managed with low molecular weight heparin, in the opinion of the Investigator, may be enrolled in the study provided they are switched to low molecular weight heparin at least 7 days prior to receiving study treatment.
- Willing and able to comply with scheduled visits, treatment plan and laboratory tests
- No concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder
- Men who are sterile (including vasectomy confirmed by post vasectomy semen analysis) OR agree to use a condom with spermicide and to not donate sperm during the study and for at least 90 days following last dose of Eribulin ORA
- Female subjects must be postmenopausal (>12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or must be using highly effective contraception (ie, oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for 90 days after their last dose of assigned study treatment.
- Subjects who are of childbearing potential must have a negative serum pregnancy test at Screening and within 72 hours before the first dose.
Who cannot join
- Subjects who have received recent anti-cancer therapy defined by:
- Chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies (but excluding nitrosurea, mitomycin-C, targeted therapy) ≤28 days prior to starting study drug, or who have not recovered from side effects of such therapy to Grade 1. Subjects receiving luteinizing hormone-releasing hormone (LHRH) agonists may be considered for enrollment after discussion with the Sponsor.
- Last administration of nitrosurea or mitomycin-C ≤42 days prior to starting study drug, or who have not recovered from the side effects of such therapy to Grade 1
- Targeted therapy (eg, sunitinib, sorafenib, pazopanib) ≤14 days prior to starting study drug, or who have not recovered from the side effects of such therapy to Grade 1; or
- Radiotherapy ≤28 days prior to starting study drug, or ≤14 days prior to starting study drug in the case of localized radiotherapy (eg, for analgesic purpose or for lytic lesions at risk of fracture), or who have not recovered from radiotherapy toxicities to Grade 1.
- Subject who have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drugs (including gastric bypass surgery and total gastrectomy).
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- Subjects who have undergone major surgery (eg, intra-thoracic, intra-abdominal or intrapelvic), open biopsy or significant traumatic injury ≤28 days prior to starting study treatment, or subjects who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤7 days prior to starting study drug, or who have not recovered from side effects of such procedure or injury
- Subjects with congenital long QT syndrome
- Uncontrolled concurrent illness, including but not limited to ongoing or active serious infection requiring systemic antimicrobials (within 14 days prior to first dose), uncontrolled arterial hypertension (>160/100 mm/Hg on antihypertensive medications), chronic pulmonary disease requiring oxygen, known bleeding disorders, uncontrolled endocrine diseases, altered mental status or psychiatric illness/social situations that would limit compliance with protocol requirements.
- Known or suspected diagnosis of human immunodeficiency virus (HIV) or chronic active Hepatitis B or C, or cirrhosis.
- Symptomatic or uncontrolled brain metastases requiring current treatment (less than 28 days from last cranial radiation or 28 days from last steroids use).
- Impaired cardiac function or clinically significant cardiac disease including the following:
- Clinically significant arrhythmias (except chronic well controlled atrial fibrillation)
- New York Heart Association (NYHA) Class III or IV congestive heart failure
- Unstable angina pectoris within the last 6 months
- Myocardial infarction within the last 6 months
- Subjects with a healing or open wound
- Lack of recovery of prior AEs to Grade ≤1 severity (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v4.03)3 (except alopecia or lymphopenia) due to medications administered prior to the first dose of the trial drugs.
- Any other condition or finding (including social situation) that in the opinion of the Investigator may render the patient at excessive risk for treatment complications or may not be able to provide evaluable outcome information.
- Pregnant or breast-feeding women
- Known allergy to any of the formulation components of Eribulin ORA
- Currently taking following prohibited concomitant medication:
- Strong cytochrome P450 (CYP) 3A4 inducer (eg, rifampin or St. John's Wort) or a strong CYP3A4 inhibitor (eg, ketoconazole) within 14 days prior to treatment administration
- Medication known to be strong P-gp inhibitors or inducers. Subjects who are taking such medications but who are otherwise eligible may be enrolled if they discontinue the medication 7 days before dosing and remain off that medication during treatment with Eribulin ORA.
- An oral medication with a narrow therapeutic index known to be a P-gp substrate (eg, digoxin, dabigatran, colchicine) within 1 day prior to start of Eribulin ORA dosing in the study
- Drugs known to prolong the QT interval, including Class Ia and III antiarrhythmics
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: A Phase I Study With Expansion Cohorts to Assess the Safety, Tolerability, and Activity of Eribulin ORA in Subjects With Solid Tumors
This is a nonrandomized, open-label, dosed escalation, safety activity, and PK study to determine the MTD and optimal dosing regimen of Eribulin ORA.
Read the detailed description
This is a multicenter, open-label safety, tolerability, pharmacokinetic, and activity study. Eligible subjects will be adults with advanced solid tumors.
Groups of 3 to 6 subjects will receive a single dose of Eribulin ORA on Day 1 and Day 8 of a 21 day cycle and will be followed for toxicity. If non linearity in PK is observed, additional subjects will be added with study drug administered on Day 1 and 8 once every three weeks cycle. Subjects who tolerate the study drug and have stable disease or better response will be eligible to receive ongoing treatment.
- Conditions
- Solid Tumor
- Being tested
- Eribulin ORA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eribulin ORACombination product
Oral eribulin mesylate will be supplied as an aqueous solution and HM30181A-UK
| Study group | Role | What they receive |
|---|---|---|
| Eribulin ORA | Experimental | To determine the MTD of Eribulin ORA (oral eribulin mesylate and HM30181A) when administered on Day 1 and Day 8 of a 3 weeks cycle. Receives: Combination Product: Eribulin ORA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation: Maximum Tolerated Dose
Occurrence of Dose-limiting toxicity (DLT) in all patients who received at lest one dose of Eribulin ORA.
Measured: 3 weeks
Dose Expansion: Occurrence of Grade 3 and 4 treatment-related adverse
Evaluate the occurrence of Grade 3 and 4 treatment-related adverse events to assess the safety of Eribulin IV or Eribulin ORA.
Measured: 6 weeks
Secondary outcomes (3)
Dose Escalation: Safety
Occurrence of adverse events in all patients who signed the informed consent .
Measured: Up to 24 months
Dose Escalation: Bioavailability
Pharmacokinetic analysis of Area Under the Curve (AUC), Time to Maximum Effect (Tmax), and Peak Plasma Concentration (Cmax) will be done to determine bioavailability of Eribulin IV or Eribulin Ora in all patients who received at least one dose of Eribulin ORA.
Measured: Up to 24 months
Dose Escalation: Tumor Response
Evaluate objective tumor response rate for confirmed Partial, Stable, Complete Response, or Progression Disease in all patients who receive at lease one dose of Eribulin IV or Eribulin ORA.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start29 Jul 2019
- Primary completion2 Mar 2022
- Study completion2 Mar 2022
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Hope Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Cutler, MD, Study director, Health Hope Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013217
- Sponsor's protocol ID
- ATX-ERB-001
- Status last verified
- Apr 2025
- First submitted
- 9 Jan 2019
- Last updated
- 13 Apr 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study With Expansion Cohorts to Assess the Safety, Tolerability, and Activity of Eribulin ORA in Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT04013217
- Acronym / sponsor ID
- ATX-ERB-001
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Health Hope PharmaIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 9 Jul 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.
This is a nonrandomized, open-label, dosed escalation, safety activity, and PK study to determine the MTD and optimal dosing regimen of Eribulin ORA.
Detailed description
This is a multicenter, open-label safety, tolerability, pharmacokinetic, and activity study. Eligible subjects will be adults with advanced solid tumors.
Groups of 3 to 6 subjects will receive a single dose of Eribulin ORA on Day 1 and Day 8 of a 21 day cycle and will be followed for toxicity. If non linearity in PK is observed, additional subjects will be added with study drug administered on Day 1 and 8 once every three weeks cycle. Subjects who tolerate the study drug and have stable disease or better response will be eligible to receive ongoing treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eribulin ORA | Experimental | Combination Product: Eribulin ORATo determine the MTD of Eribulin ORA (oral eribulin mesylate and HM30181A) when administered on Day 1 and Day 8 of a 3 weeks cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Able to understand and sign an informed consent form (ICF)
- Male and female adults, ≥18 years of age
- Histologically or cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; subjects enrolling in the dose expansion cohort must have breast cancer or liposarcoma.
- Must have at least one measurable site of disease as defined as per RECIST v1.1 criteria (dose expansion) or evaluable disease (dose escalation only)
- Eastern Cooperative Oncology Group (ECOG)2 Performance Status ≤1
Key exclusion criteria (26 listed)
- Subjects who have received recent anti-cancer therapy defined by:
- Subject who have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drugs (including gastric bypass surgery and total gastrectomy).
- Subjects who have undergone major surgery (eg, intra-thoracic, intra-abdominal or intrapelvic), open biopsy or significant traumatic injury ≤28 days prior to starting study treatment, or subjects who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤7 days prior to starting study drug, or who have not recovered from side effects of such procedure or injury
- Subjects with congenital long QT syndrome
- Uncontrolled concurrent illness, including but not limited to ongoing or active serious infection requiring systemic antimicrobials (within 14 days prior to first dose), uncontrolled arterial hypertension (>160/100 mm/Hg on antihypertensive medications), chronic pulmonary disease requiring oxygen, known bleeding disorders, uncontrolled endocrine diseases, altered mental status or psychiatric illness/social situations that would limit compliance with protocol requirements.
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 ORAOral eribulin mesylate will be supplied as an aqueous solution and HM30181A-UK | Combination product | Eribulin ORA |
Primary outcome
Dose Escalation: Maximum Tolerated Dose
Time frame: 3 weeks
Occurrence of Dose-limiting toxicity (DLT) in all patients who received at lest one dose of Eribulin ORA.
Dose Expansion: Occurrence of Grade 3 and 4 treatment-related adverse
Time frame: 6 weeks
Evaluate the occurrence of Grade 3 and 4 treatment-related adverse events to assess the safety of Eribulin IV or Eribulin ORA.
3 secondary outcomes
Dose Escalation: Safety
Time frame: Up to 24 months
Dose Escalation: Bioavailability
Time frame: Up to 24 months
Dose Escalation: Tumor Response
Time frame: up to 24 months
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
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Solid Tumors
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.
David Cutler, MD study director
Health Hope Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Eribulin ORA in people with Solid Tumor, run by Health Hope Pharma at 1 site in United States.
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 22 inclusion and 26 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: stopped early, as of the sponsor's last update on 13 Apr 2025. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
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?
Dose Escalation: Maximum Tolerated Dose (time frame: 3 weeks). The study lists 2 primary outcomes in all. 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 13 Apr 2025.