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

NCT04243434 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2020-04-16

No results posted yet for this study

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

Interventions

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.

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)

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)

Sponsors & Collaborators

  • Axis Clinicals Limited

    collaborator INDUSTRY

  • Acrotech Biopharma Inc.

    lead INDUSTRY

Principal Investigators

  • Wasim Khan, MD · Acrotech Biopharma Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-15
Primary Completion
2020-08-15
Completion
2020-10-15
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04243434 on ClinicalTrials.gov