Clinical trial · Interventional
To Study the Concentration Level of, Doxil, and Doxorubicin at Various Time Frames
A Bio Equivalence Study of DOXIL and Doxorubicin in Subjects With Lymphoma, Leukemia and Carcinoma
NCT03975205CI-TRIAL-00038942DoxilunknownEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicin | Drug | Doxorubicin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Doxil
- description
- 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
- interventionNames
- Drug: Doxorubicin
- type
- EXPERIMENTAL
- label
- doxorubicin
- description
- 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
- interventionNames
- Drug: Doxorubicin
Primary outcomes (1)
- measure
- Bioavailability of Doxil versus Doxorubicin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.