To Study the Concentration Level of, Doxil, and Doxorubicin at Various Time Frames

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2019-12-31

Brief Summary

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Doxil or Doxorubicin to be administered was administered in a dose of 50 mg/m2 as infusion over 15 minutes. Blood samples to be obtained at 0, 1, 2, 3, 4, 8, 12, 24, 48 and 72 hours

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Detailed Description

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Comparison of AUC in a single dose of Doxorubicin vs single dose of Doxil \[ Time Frame: 0, 1, 2, 3, 4, 8, 12, 24, 48 and 72 hours. Cycle is defined as 28 days) The primary objective of this study is to determine the pharmacokinetic equivalence of Doxorubicin and Doxil as a single dose in patients with carcinomas, lymphomas and leukemia's. The outcome measure will be determined by analyzing the concentration from each patient at pre-specified time points and calculating Area under the curve (AUC) and Peak Plasma Concentration (C max)to determine % variability between doxorubicin and Doxil within each patient.

Conditions

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Lymphoma Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

A Phase 1, single-blind, randomized, two-way, crossover Bio-equivalence study of Intravenously administered Doxorubicin in Patients With lymphomas, leukemia's and carcinoma That Has Progressed or Recurred After Platinum-based Chemotherapy

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Doxil

This group of patients will receive Intravenous Doxil of 50mgm/m2 over 15 minutes and plasma concentration will be measured at time Frame: 0, 1, 2, 3, 4, 8, 12, 24, 48 and 72 hours. Cycle is defined as 28 days

Group Type ACTIVE_COMPARATOR

Doxorubicin

Intervention Type DRUG

To measure bioavailabity of Doxil versus Doxorubicin

doxorubicin

This group of patients will receive Intravenous Doxorubicin of 50mgm/m2 over 15 minutes and plasma concentration will be measured at time Frame: 0, 1, 2, 3, 4, 8, 12, 24, 48 and 72 hours. Cycle is defined as 28 days

Group Type EXPERIMENTAL

Doxorubicin

Intervention Type DRUG

To measure bioavailabity of Doxil versus Doxorubicin

Interventions

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Doxorubicin

To measure bioavailabity of Doxil versus Doxorubicin

Intervention Type DRUG

Other Intervention Names

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Doxil

Eligibility Criteria

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Inclusion Criteria

* Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria

Have confirmed diagnosis of lymphomas. leukemia's and carcinoma to be treated with Doxil or Doxorubin Have a normal left ventricular ejection fraction (LVEF) based on institutional ranges.

Be \>/= 18 and \</= 75 years of age Sign a written Institutional Review Board (IRB)-approved informed consent form Have a negative pregnancy test, if patient is of child-bearing potential. Agree to use effective contraceptive methods during the study (nonsterile patients of childbearing potential) Have acceptable liver function, renal function and hematologic status based on the institution.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No