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

NCT04243434 | Unknown Phase 1 FDA Drug

• 1 other identifier: SPI-MAR-101
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hematologic Diseases

Keywords

Hematology; Hematological Malignancy; CHOP; R-CHOP

Outcome Measures

Primary Outcomes (1)

• PK analysis Area under the concentration time curve (AUC)

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

  6 weeks

Study Arms (2)

Cohort A

EXPERIMENTAL

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; Combination Product: CHOP; Combination Product: R-CHOP

Cohort B

EXPERIMENTAL

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; Combination Product: CHOP; Combination Product: R-CHOP

Interventions

Vincristine Sulfate Liposome DRUG

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.

Also known as: Marqibo

Cohort A; Cohort B

CHOP COMBINATION_PRODUCT

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)

Also known as: cyclophosphamide. doxorubicin, vincristine , and prednisone, Adriamycin, (Oncovin)

Cohort A; Cohort B

R-CHOP COMBINATION_PRODUCT

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)

Also known as: cyclophosphamide. doxorubicin, vincristine , prednisone + Rituximab

Cohort A; Cohort B

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acrotech Biopharma Inc.: lead
• Axis Clinicals Limited: collaborator

MeSH Terms

Conditions

Hematologic Diseases; Hematologic Neoplasms

Interventions

Vincristine; AC protocol; Prednisone; Doxorubicin; R-CHOP protocol; Rituximab

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Wasim Khan, MD

  Acrotech Biopharma Inc.

  STUDY DIRECTOR

Central Study Contacts

Melissa Brugard, CTM, MSW

CONTACT

218.284.9863; m.burgard@axisclinicals.com

Study Design

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

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: January 28, 2020
• Study Start: August 15, 2020
• Primary Completion: August 15, 2020
• Study Completion: October 15, 2020
• Last Updated: April 16, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share