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

NCT03975205 | Unknown Early Phase 1 FDA Drug

• 1 other identifier: Global CRO Doxil
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Lymphoma Leukemia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Doxil

ACTIVE COMPARATOR

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

Drug: Doxorubicin

doxorubicin

EXPERIMENTAL

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

Drug: Doxorubicin

Interventions

Doxorubicin DRUG

To measure bioavailabity of Doxil versus Doxorubicin

Also known as: Doxil

Doxil; doxorubicin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Sutphin Drugs: lead
• Bharath Charitable Cancer Hospital and Institute: collaborator

Study Sites (1)

Bharat Cancer Hospital

Surat, Gujarat, 11435, India

Location

MeSH Terms

Interventions

Doxorubicin; liposomal doxorubicin

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Central Study Contacts

Ajai Prakash

CONTACT

7185260310; ajaiprakashny@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Model Details: 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

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 5, 2019
• Study Start: July 1, 2019
• Primary Completion: October 31, 2019
• Study Completion: December 31, 2019
• Last Updated: June 5, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)