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Ovarian CancerPhase 1NCT02237690

Assess Bioequivalence of Two Formulations of Doxorubicin Hydrochloride Liposome in Female Patients With Ovarian Cancer

A Phase 1 study testing Doxorubicin hydrochloride liposome in people with Ovarian Cancer, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multi-center, single-dose, open-label, randomized, balanced, two-treatment, two-cycle, two-sequence crossover study to assess bioequivalence of test (T) and reference (R) formulations of doxorubicin hydrochloride liposome injection in female patients with ovarian cancer. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Doxorubicin hydrochloride liposome
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
3 sitesChina
Study dates
Sep 2014to Aug 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to give written informed consent for participation in the trial;
  • Females age 18 to 75 years, inclusive;
  • Histologically or cytologically proven ovarian cancer, which has progressed or recurred by CT/MRI confirmation after platinum-based chemotherapy;
  • ECOG (Eastern Cooperative Oncology Group) Performance Status 0 - 2;
  • Patient is expected to be able to receive both doses of Doxorubicin Hydrochloride Liposome Injection and participate in the trial for at least 56 days.
  • Urine pregnancy test before dosing of both cycle1 and cycle 2 must be negative (not including postmenopausal or surgically sterile women); Agree to use an approved method of birth control (condom with spermicide, diaphragm or cervical cap with spermicide, or intrauterine device); or patients of non-childbearing potential who are either surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or >1 year postmenopausal with follicle-stimulating hormone in the postmenopausal range;
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  • 30days or 5 half-lives (whichever is longer) have elapsed from the completion of previous cancer therapy, and patients must have recovered to < Grade 2 or be at new stable baseline from any related toxicities;
  • Adequate renal, hepatic and bone marrow function without blood product or hematopoietic growth factor support:
  • Able to comply with study requirements in the opinion of the Principal Investigator

Who cannot join

  • Significant allergy, hypersensitivity or idiosyncratic reactions to doxorubicin and/or any related compounds;
  • History or presence of cardiac disease rated New York State Heart Association Classification class 2 or greater;
  • Uncontrolled cardiac arrhythmia or other findings on screening electrocardiogram (ECG) which could, in the judgment of the Principal Investigator, put the patient at undue risk for participation in the trial;
  • LVEF（left ventricular ejection fraction） below 50% or below institutional normal at screening;
  • Prior radiation therapy to mediastinum;
  • Concomitant use of other cytotoxic or cytostatic drugs or of radiotherapy;
  • Active, uncontrolled infection, including opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, or P. carinii;
  • Use of prescription or non-prescription herbal and dietary supplements, within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Cancer Institute& Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • QiLu Hospital of Shandong University

    Jinan, Shandong, 250012

Other trials in China

About this study

Official title: A Randomized, Open Label, Single-Dose, Two-Cycle Crossover Study to Assess Bioequivalence of Test and Reference Formulations of Doxorubicin Hydrochloride Liposome Injection in Female Patients With Ovarian Cancer

This is a multi-center, single-dose, open-label, randomized, balanced, two-treatment, two-cycle, two-sequence crossover study to assess bioequivalence of test (T) and reference (R) formulations of doxorubicin hydrochloride liposome injection in female patients with ovarian cancer.

Each patient will be randomized to one of two treatment sequences (RT or TR) according to a randomization scheme prepared prior to the start of the trial.There will be at least 4-week apart between each single-dose administration. Serial blood samples for determination of free doxorubicin and liposomal encapsulated doxorubicin plasma concentrations for PK analysis will be obtained in each cycle.

The 90% confidence intervals on the GMR(geometric mean ratio) of test to reference products of free and liposome encapsulated doxorubicin for PK must be within 80-125% to demonstrate bioequivalence.

Read the detailed description

This study has an adaptive 2-stage design. Bioequivalence based on encapsulated doxorubicin will be tested at the end of Stage 1 . An interim analysis of free doxorubicin will be performed at the end of Stage 1 . If needed, the study may continue into Stage 2 with additional number of ovarian cancer patients determined based on the interim analysis; and a final evaluation of bioequivalence for free doxorubicin will be performed at the end of Stage 2. Each patient will be randomized to one of two treatment sequences (RT or TR) according to a randomization scheme prepared prior to the start of the trial. Serial blood samples for determination of free doxorubicin and liposomal encapsulated doxorubicin plasma concentrations for PK analysis will be obtained in each cycle.

The 90% confidence intervals on the GMR（geometric mean ratio） of test to reference products of free and liposome encapsulated doxorubicin for PK must be within 80-125% to demonstrate bioequivalence.

Safety data will be summarized and listed. Adverse events will be coded and classified by system organ class and preferred term using Common Terminology Criteria for Adverse Events. A summary of all drug-related adverse events will also be generated. Clinical laboratory data will be summarized descriptively and listed by treatment group. The change from pre dose to the end of the study will also be summarized. Prior and concomitant medications will be coded with the World Health Organization Drug Dictionary and listed. Vital signs and electrocardiogram data will be summarized and listed by dose group and visit.

Conditions
Ovarian Cancer
Being tested
Doxorubicin hydrochloride liposome
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Doxorubicin hydrochloride liposomeDrug

    50mg/m2,IV on day1 of each cycle,On Day 1 of Cycle 2, patients will crossover to the alternate reference or test formulation,After completion of Cycle 2 (Day 28), patients will be continued on the treatment of Doxorubicin Hydrochloride Liposome Injection up to 4 more cycles if tolerance permits under guidance of their attending physicians.

Study groups in NCT02237690
Study groupRoleWhat they receive
doxorubicin hydrochloride liposome（Libaoduo）ExperimentalUse the test drug(doxorubicin hydrochloride liposome-Libaoduo,from Fudan-Zhangjiang ),then use the reference drug(doxorubicin hydrochloride liposome，from Sunpharma) after at least 4-weeks.
Receives: Drug: Doxorubicin hydrochloride liposome
doxorubicin hydrochloride liposomeActive comparatorUse the reference drug(doxorubicin hydrochloride liposome，from Sunpharma),then use the test drug drug(doxorubicin hydrochloride liposome-Libaoduo,from Fudan-Zhangjiang) after at least 4-weeks.
Receives: Drug: Doxorubicin hydrochloride liposome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pharmacokinetic（PK） parameter:the maximum plasma doxorubicin concentrations(Cmax)

    The study endpoint will use the PK parameter(Cmax) for free doxorubicin and liposome encapsulated doxorubicin

    Measured: 2 cycles

  2. PK parameter:the areas under the plasma concentration versus time curve calculated from 0 to the last measurable observation(AUC0-t)

    The study endpoint will use the PK parameter(AUC0-t) for free doxorubicin and liposome encapsulated doxorubicin(AUC0-t)

    Measured: 2 cycles

  3. PK parameter:the areas under the plasma concentration versus time curve extrapolated from 0 to infinity(AUC0-inf)

    The study endpoint will use the PK parameter(AUC0-inf) for free doxorubicin and liposome encapsulated doxorubicin

    Measured: 2 cycles

Secondary outcomes (2)

  1. incidence of treatment-emergent adverse events (TEAEs)

    Measured: 2 cycles

  2. study discontinuation information

    Measured: 2 cycles

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionAug 2015
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02237690
Sponsor's protocol ID
Libaoduo-BE-002
Status last verified
Jun 2017
First submitted
31 Aug 2014
Last updated
5 Jun 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Doxorubicin hydrochloride liposome in people with Ovarian Cancer, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pharmacokinetic（PK） parameter:the maximum plasma doxorubicin concentrations(Cmax) (time frame: 2 cycles). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02237690.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2017.

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