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A Study of Doxorubicin Hydrochloride Liposome Injection in Subjects With Ovarian Cancer.

NCT03681548 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2019-11-20

No results posted yet for this study

Summary

Bioequivalence study is proposed to be carried out on patients of ovarian cancer, who are already receiving or who in the opinion of their treating physicians are candidates for Doxorubicin liposomal injection therapy .

Conditions

  • Ovarian Cancer Recurrent

Interventions

DRUG

Doxorubicin Hydrochloride Liposome Injection

50mg/m2, IV on Day 1 of each cycle, On Day 1 of Cycle 1 patients will receive either reference or test product, On Day 1 of Cycle 2 , patients will crossover to the alternate reference or test formulation

Sponsors & Collaborators

  • Lambda Therapeutic Research Ltd.

    collaborator INDUSTRY

  • Ayana Pharma Ltd.,

    lead INDUSTRY

Principal Investigators

  • Rakesh J Patel, MD Pharm · Lambda Therapeutic Research Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-29
Primary Completion
2019-02-08
Completion
2019-03-07
FDA Drug
Yes

Countries

  • India

Study Locations

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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 NCT03681548 on ClinicalTrials.gov