Evaluate Eribulin ORA in Subjects With Solid Tumors

NCT04013217 | Terminated Phase 1 FDA Drug

• 1 other identifier: ATX-ERB-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Dose Escalation: Maximum Tolerated Dose

  Occurrence of Dose-limiting toxicity (DLT) in all patients who received at lest one dose of Eribulin ORA.

  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.

  6 weeks

Secondary Outcomes (3)

• Dose Escalation: Safety

  Up to 24 months

• Dose Escalation: Bioavailability

  Up to 24 months

• Dose Escalation: Tumor Response

  up to 24 months

Study Arms (1)

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.

Combination Product: Eribulin ORA

Interventions

Eribulin ORA COMBINATION_PRODUCT

Oral eribulin mesylate will be supplied as an aqueous solution and HM30181A-UK

Eribulin ORA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• Health Hope Pharma: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Study Officials

• David Cutler, MD

  Health Hope Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: July 9, 2019
• Study Start: July 29, 2019
• Primary Completion: March 2, 2022
• Study Completion: March 2, 2022
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

US (1)