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Ovarian Cancer RecurrentPhase 1NCT03681548

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

A Phase 1 study testing Doxorubicin Hydrochloride Liposome Injection in people with Ovarian Cancer Recurrent, run by Ayana Pharma Ltd., at 15 sites in India.

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

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 . Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Ovarian Cancer Recurrent
What is being tested?
Doxorubicin Hydrochloride Liposome Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
15 sitesIndia
Study dates
29 Aug 2018to 7 Mar 2019
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 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult female subjects between 18 to 65 years of age (both inclusive) at the time of screening visit.
  • Subjects with histologically or cytological proven ovarian cancer, whose disease has progressed or recurred after platinum-based chemotherapy and scheduled to start therapy with or who are already receiving an approved dose of 50 mg per meter square Doxorubicin Hydrochloride Liposome Injection product.
  • Subjects expected to be able to receive both doses of Doxorubicin Hydrochloride Liposome Injection.
  • Subjects eligible for receiving a dose of 50 mg per meter square of Doxorubicin Hydrochloride Liposome Injection.
  • Subjects with Performance less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) performance scale
  • Cardiac function (LVEF) greater than or equal to 50 percentage.
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  • Adequate renal, hepatic and bone marrow function without blood product or hematopoietic growth factor support.
  • Subjects able to understand the investigational nature of this study.
  • Availability of subject for the entire study period and willingness to adhere to protocol requirements.
  • For subjects of child-bearing potential, serum beta HCG pregnancy test at screening and urine pregnancy test prior to dosing must be negative and subjects agree to use an acceptable and effective approved method of contraception
  • Subjects of non-childbearing potential who are either surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or greater than 1 year postmenopausal with follicle stimulating hormone in the postmenopausal range
  • Signed written informed consent.

Who cannot join

  • Subjects with history or presence of significant:
  • Allergy or significant history of hypersensitivity or idiosyncratic reactions to a conventional formulation of Doxorubicin Hydrochloride and/or any components of Doxorubicin Hydrochloride liposome injection.
  • Clinically significant pulmonary, hepatic, renal, bone marrow, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
  • Impaired cardiac function
  • Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within the past one year.
  • Active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, p. carinii or other microorganism (bacterial, viral or fungal).
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  • Clinically significant illness (except ovarian cancer) within four weeks prior to dosing.
  • Prior radiation therapy to mediastinum
  • Concomitant use of other cytotoxic or cytostatic drugs or of radiotherapy within four weeks prior to dosing
  • Subject under treatment of myelotoxic drugs, other than doxorubicin (liposomal).
  • Use of prescription or non-prescription herbal and dietary supplements, within 7 days prior to dosing.
  • Subjects with other known active malignancies requiring treatment within 3 years (except for ovarian and/or skin cancer).
  • Subjects with known brain metastasis and/or subjects considered for radiotherapy treatment.
  • Positive result to any of the following: HIV-1/2, hepatitis A, B and C; syphilis.
  • Use of CYP3A4 enzyme-modifying drugs in the previous 30 days prior to dosing and during the study
  • Subjects who have:
  • Systolic blood pressure less than 90 mmHg or more than 160 mmHg
  • Diastolic blood pressure less than 60 mmHg or more than 95 mmHg
  • Pulse rate below 55 per min. or above 100 per min14.
  • Subjects with abnormal laboratory parameters
  • Subject is currently enrolled in, or has not yet completed a period of at least 30 days since ending other investigational device or drug trial(s).
  • Subjects who are legally detained in an official institute.
  • Subjects with prior doxorubicin exposure that would result in a total lifetime exposure of 550 mg per meter square or more after four cycles of treatment.
  • Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments
  • Females of childbearing potential unwilling to use acceptable contraception (as identified in the protocol) throughout the trial and for 6 months after the last dose of study drug.
  • Pregnant or breast-feeding subjects.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

India15 sites

  • Sparsh Hospitals & Critical Care (P) Ltd.

    Bhubaneswar, Odisha, 751007

  • Sri Ramachandra Medical Centre

    Chennai, Tamil Nadu, 600116

  • Saveetha Medical College & Hospital

    Chennai, Tamil Nadu, 602105

  • VGM Hospital

    Coimbatore, Tamil Nadu, 641005

  • MNJ Institute of Oncology & Regional Cancer Center

    Hyderabad, Andhra Pradesh, 500004

  • K R Hospital

    Mysore, Karnataka, 570001

  • Apex Wellness Rishikesh Hospital

    Nashik, Maharashtra, 422 002

  • HCG Manavata Cancer Centre

    Nashik, Maharashtra, 422002

  • Noble Hospital Pvt Ltd.

    Pune, Maharashtra, 411013

  • Nirmal Hospital Pvt. Ltd.

    Surat, Gujarat, 395002

  • Unique Hospital - Multispeciality and Research Institute

    Surat, Gujarat, 395002

  • Aman Hospital and Research Center

    Vadodara, Gujarat, 390021

  • Kailash Cancer Hospital And Research Center

    Vadodara, Gujarat, 391760

  • HCG City Cancer Centre

    Vijayawada, Andhra Pradesh, 520002

  • Mahatma Gandhi Cancer Hospital & Research Institute

    Visakhapatnam, Andhra Pradesh, 530017

Other trials in India

About this study

Official title: A Randomized, Open Label, Two Arm, Single Dose, Crossover, Bioequivalence Study of Ayana Pharma's Doxorubicin Hydrochloride Liposome Injection (LC-101) (Investigational Product) and the US Reference Standard Doxorubicin Hydrochloride Liposome Injection (Sun Pharma), in Subjects With Ovarian Cancer.

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 .

Read the detailed description

This study is a randomized, open label, two arm, single dose, crossover bioequivalence study. This study will be conducted in female subjects aged 18 to 65 years diagnosed with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy and who are already receiving or scheduled to start therapy with Doxorubicin Hydrochloride Liposome Injection product. Each subject will be randomized to one of the two treatment sequences (RT or TR) according to a randomization scheme prepared prior to start of the trial. Serial blood samples for determination of free and liposomal encapsulated doxorubicin plasma concentration for PK analysis will be obtained in each cycle., This study has an adaptive 2-stage design. A sufficient number of subjects with ovarian cancer shall be recruited to have approximately 42 evaluable subjects completing all follow up procedures (Stage 1). An interim analysis of free and encapsulated doxorubicin will be performed at the end of Stage 1. If the bioequivalence of encapsulated and free doxorubicin has been established, then the study will be stopped. Otherwise, the study may continue into Stage 2 with additional number of ovarian cancer subjects. A final evaluation of bioequivalence based on free and encapsulated doxorubicin will be performed at the end of Stage 2 and will include all enrolled subjects completing the study. Bioequivalence criteria: the 94.12% confidence interval of the ratio of geometric means of TEST to REFERENCE for Cmax, AUC0-t, AUC0-∞, for free and encapsulated doxorubicin should be between 80.00% and 125.00%.

Being tested
Doxorubicin Hydrochloride Liposome Injection
Keywords
liposomal doxorubicin injection, bioequivalence study, ovarian cancer
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 Liposome InjectionDrug

    Also called Doxorubicin Hydrochloride Liposomal injection 20 mg/10 mL

    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

Study groups in NCT03681548
Study groupRoleWhat they receive
Reference Product - RActive comparatorDoxorubicin Hydrochloride Liposome Injection (Sun Pharma); 20 mg/10 mL i.e. 2 mg/mL (50mg/m2 dose). As this is a cross over study, subjects receiving in Cycle 1 the Reference Product (doxorubicin hydrochloride liposome injection SunPharma), will receive in Cycle 2 the Test Product (doxorubicin hydrochloride liposome injection (Ayana); after at least 4 weeks (RT).
Receives: Drug: Doxorubicin Hydrochloride Liposome Injection
Test Product - TExperimentalDoxorubicin Hydrochloride Liposome Injection (Ayana Pharma Ltd); 20 mg/10 mL i.e. 2 mg/mL (50mg/m2 dose). As this is a cross over study, subjects receiving in Cycle 1 the Test Product (doxorubicin hydrochloride liposome injection (Ayana)will receive in Cycle 2 the Reference Product (doxorubicin hydrochloride liposome injection SunPharma); after at least 4 weeks (RT).
Receives: Drug: Doxorubicin Hydrochloride Liposome Injection

What is being measured

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

  1. Assessment of bioequivalence using Cmax of encapsulated and free doxorubicin in plasma

    Assessment of bioequivalence of LC-101 (TEST Product) in comparison to the US Reference standard (REFERENCE product). Bioequivalence will be assessed using maximum plasma doxorubicin concentration (Cmax) of encapsulated and free doxorubicin measurements in plasma.

    Measured: Throughout 15 days after both dosing.

  2. Assessment of bioequivalence using AUC (0-t) of encapsulated and free doxorubicin in plasma

    Assessment of bioequivalence of LC-101 (TEST Product) in comparison to the US Reference standard (REFERENCE product). Bioequivalence will be assessed using areas under the plasma concentration versus time curve calculated from 0 to the last measurable observation (AUC 0-t) of encapsulated and free doxorubicin measurements in plasma.

    Measured: Throughout 15 days after both dosing.

  3. Assessment of bioequivalence using AUC (0-inf) of encapsulated and free doxorubicin in plasma

    Assessment of bioequivalence of LC-101 (TEST Product) in comparison to the US Reference standard (REFERENCE product). Bioequivalence will be assessed using areas under the plasma concentration versus time curve calculated from 0 to infinity (AUC 0-inf) of encapsulated and free doxorubicin measurements in plasma.

    Measured: Throughout 15 days after both dosing.

Secondary outcomes (4)

  1. Assessment of bioequivalence using Cmax of total doxorubicin in plasma

    Assessment of bioequivalence of LC-101 (TEST Product) in comparison to the US Reference standard (REFERENCE product). Bioequivalence will be assessed using Cmax of total doxorubicin measurements in plasma.

    Measured: Throughout 15 days after both dosing.

  2. Assessment of bioequivalence using AUC (0-t) of total doxorubicin in plasma

    Assessment of bioequivalence of LC-101 (TEST Product) in comparison to the US Reference standard (REFERENCE product). Bioequivalence will be assessed using AUC (0-t) of total doxorubicin measurements in plasma.

    Measured: Throughout 15 days after both dosing.

  3. Assessment of bioequivalence using AUC (0-inf) total doxorubicin as secondary analyte

    Assessment of bioequivalence of LC-101 (TEST Product) in comparison to the US Reference standard (REFERENCE product). Bioequivalence will be assessed using AUC (0-inf) of total doxorubicin measurements in plasma.

    Measured: Throughout 15 days after both dosing.

  4. Assessment of safety

    Assessment of incidence of adverse events

    Measured: Troughout 42 days after first dosing

Timeline

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

  1. First posted24 Sep 2018
  2. Study start29 Aug 2018
  3. Primary completion8 Feb 2019
  4. Study completion7 Mar 2019

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
Model description
Bioequivalence study
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03681548
Sponsor's protocol ID
LC-101-02
Other IDs
0384-18, CTRI/2018/07/014835
Status last verified
Nov 2019
First submitted
17 Sep 2018
Last updated
20 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Doxorubicin Hydrochloride Liposome Injection in people with Ovarian Cancer Recurrent, run by Ayana Pharma Ltd., at 15 sites in India.

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 12 inclusion and 26 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 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in India. 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?

Assessment of bioequivalence using Cmax of encapsulated and free doxorubicin in plasma (time frame: Throughout 15 days after both dosing.). 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 NCT03681548.

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 20 Nov 2019.

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