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

Lymphoma Leukemia Clinical Trial

— Doxil  

Official title:

A Bio Equivalence Study of DOXIL and Doxorubicin in Subjects With Lymphoma, Leukemia and Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03975205
• Other study ID #: Global CRO Doxil
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: July 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2019
• Source: Sutphin Drugs
• Contact: Ajai Prakash
• Phone: 7185260310
• Email: ajaiprakashny[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Inclusion 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.

Exclusion criteria Any Medical related exclusion criteria as per the institution. Are unwilling or unable to comply with procedures required in this protocol Have known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C Have a serious nonmalignant disease (e.g., hydronephrosis, liver failure, significantly impaired hepatic function, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor Are currently receiving any other investigational agent Have exhibited allergic reactions to doxorubicin or a similar structural compound

Related Conditions & MeSH terms

• Leukemia
• Lymphoma
• Lymphoma Leukemia

Intervention

Drug:
• Doxorubicin
To measure bioavailabity of Doxil versus Doxorubicin

Locations

Country	Name	City	State
India	Bharat Cancer Hospital	Surat	Gujarat

Sponsors (2)

Lead Sponsor	Collaborator
Sutphin Drugs	Bharath Charitable Cancer Hospital and Institute

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioavailability of Doxil versus Doxorubicin	Intravenous Doxil versus 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.; Maximum observed plasma concentration of doxorubicin versus Doxil in participants at time Frame: 0, 1, 2, 3, 4, 8, 12, 24, 48 and 72 hours. Cycle is defined as 28 days.	72 hours . Cycle defined as 28 days