PK Study on Ready-to-Use Injection (VSLI-RTU) 1 Vial & 3 Vial Formulation Marqibo® in Hematological Malignant Patients

Sponsor
Acrotech Biopharma LLC (Industry)
Overall Status
Unknown status
CT.gov ID
NCT04243434
Collaborator
Axis Clinicals Limited (Industry)
56
Enrollment
2
Arms
2
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a Phase 1, randomized, open-label, 2-way crossover, pharmacokinetic study in adult patients with hematological malignancies eligible to receive either cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen or rituximab-CHOP (R-CHOP) regimen.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Vincristine Sulfate Liposome
  • Combination Product: CHOP
  • Combination Product: R-CHOP
Phase 1

Detailed Description

Eligible patients will be randomized in a 1:1 ratio to one of 2 treatment cohorts (Cohorts A or B) in which the Marqibo formulation and the 1-vial VSLI-RTU formulation of vincristine are administered in a 2-way crossover design over 2 treatment cycles (21 days each):

  • Cohort A: Marqibo formulation given at a dose of 2.25 mg/m2 with no dose cap during Cycle 1, and VSLI-RTU formulation given at 2.25 mg/m2 with no dose cap during Cycle 2.

  • Cohort B: VSLI-RTU formulation given at a dose of 2.25 mg/m2 with no dose cap during Cycle 1 and Marqibo formulation given at 2.25 mg/m2 with no dose cap during Cycle 2.

Both formulations of vincristine sulfate LIPOSOME injection will be administered via a 60 (±10) minute IV infusion.

Blood samples for PK evaluation will be drawn at the following time points: immediately before infusion, 0.5 hour after the start of the infusion, 0.5 hour after the end of infusion (EOI), and 3, 8, 15, 24, 48, 72, and 96 hours post-EOI.

In addition to Marqibo or VSLI-RTU, all patients will receive standard doses (per institutional or regional guidelines) of cyclophosphamide, prednisone, and doxorubicin, (and rituximab if patient is on the R-CHOP regimen), on Day 1 and prednisone (or prednisolone if consistent with institutional or regional guidelines) on Days 2 to 5.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Randomized, Pharmacokinetic Study of vinCRIStine Sulfate LIPOSOME Injection Ready-to-Use (VSLI-RTU) Formulation (1-Vial) and Marqibo® Formulation (3-Vials) in Patients With Hematological Malignancies
Anticipated Study Start Date :
Aug 15, 2020
Anticipated Primary Completion Date :
Aug 15, 2020
Anticipated Study Completion Date :
Oct 15, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: Cohort A

Marqibo formulation given at a dose of 2.25 mg/m2 with no dose cap during Cycle 1, and VSLI-RTU formulation given at 2.25 mg/m2 with no dose cap during Cycle 2.

Drug: Vincristine Sulfate Liposome
Eligible patients will be randomized in a 1:1 ratio to one of 2 treatment cohorts (Cohorts A or B) to receive either the first cycle of treatment with the VSLI-RTU formulation or the Marqibo formulation and crossover to the other formulation for the second cycle.
Other Names:
  • Marqibo
  • Combination Product: CHOP
    CHOP to be administered on Day 1 on Cycle 1 & 2 ( 21-day Cycle) & prednisone administration on Days 2 to 5 on Cycle 1 & 2 ( 21-day Cycle)
    Other Names:
  • cyclophosphamide. doxorubicin, vincristine , and prednisone
  • Adriamycin, (Oncovin)
  • Combination Product: R-CHOP
    R-CHOP to be administered on Day 1 on Cycle 1 & 2 ( 21-day Cycle) & prednisone administration on Days 2 to 5 on Cycle 1 & 2 ( 21-day Cycle)
    Other Names:
  • cyclophosphamide. doxorubicin, vincristine , prednisone + Rituximab
  • Experimental: Cohort B

    VSLI-RTU formulation given at a dose of 2.25 mg/m2 with no dose cap during Cycle 1 and Marqibo formulation given at 2.25 mg/m2 with no dose cap during Cycle 2.

    Drug: Vincristine Sulfate Liposome
    Eligible patients will be randomized in a 1:1 ratio to one of 2 treatment cohorts (Cohorts A or B) to receive either the first cycle of treatment with the VSLI-RTU formulation or the Marqibo formulation and crossover to the other formulation for the second cycle.
    Other Names:
  • Marqibo
  • Combination Product: CHOP
    CHOP to be administered on Day 1 on Cycle 1 & 2 ( 21-day Cycle) & prednisone administration on Days 2 to 5 on Cycle 1 & 2 ( 21-day Cycle)
    Other Names:
  • cyclophosphamide. doxorubicin, vincristine , and prednisone
  • Adriamycin, (Oncovin)
  • Combination Product: R-CHOP
    R-CHOP to be administered on Day 1 on Cycle 1 & 2 ( 21-day Cycle) & prednisone administration on Days 2 to 5 on Cycle 1 & 2 ( 21-day Cycle)
    Other Names:
  • cyclophosphamide. doxorubicin, vincristine , prednisone + Rituximab
  • Outcome Measures

    Primary Outcome Measures

    1. PK analysis Area under the concentration time curve (AUC) [6 weeks]

      To evaluate the serum pharmacokinetics (PK) of the 1-vial VSLI-RTU formulation versus the current Marqibo 3-vial formulation for intravenous (IV) injection.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:
    • Patient has a hematological malignancy and is eligible to receive CHOP or R-CHOP regimen.

    • Patient must have adequate hematological, renal, and hepatic function as specified below within 30 days prior to the first dose of study treatment:

    • Patient has a left ventricular ejection fraction ≥50% by multigated acquisition scan or echocardiogram within 30 days prior to the first dose of study treatment.

    Key Exclusion Criteria:
    • Patient has severe neurologic disorders (Grade 3 and above) including peripheral motor and sensory, central and autonomic neuropathy.

    • Patient has a history of persistent active neurologic disorders including the demyelinating form of Charcot-Marie-Tooth syndrome, acquired demyelinating disorders, and other demyelinating conditions.

    • Patient has used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study.

    • Patient has bowel obstruction, paralytic ileus, or uncontrolled chronic constipation.

    • Patient has severe, active and uncontrolled hepatic disease or dysfunction.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Acrotech Biopharma LLC
    • Axis Clinicals Limited

    Investigators

    • Study Director: Wasim Khan, MD, Acrotech Biopharma LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Acrotech Biopharma LLC
    ClinicalTrials.gov Identifier:
    NCT04243434
    Other Study ID Numbers:
    • SPI-MAR-101
    First Posted:
    Jan 28, 2020
    Last Update Posted:
    Apr 16, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Acrotech Biopharma LLC
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 16, 2020