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

NCT03681548 | Completed Phase 1 FDA Drug

• 3 other identifiers: LC-101-020384-18CTRI/2018/07/014835
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 15

Brief 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

Keywords

liposomal doxorubicin injection; bioequivalence study; ovarian cancer

Outcome Measures

Primary Outcomes (3)

• 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.

  Throughout 15 days after both dosing.

• 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.

  Throughout 15 days after both dosing.

• 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.

  Throughout 15 days after both dosing.

Secondary Outcomes (4)

• Assessment of bioequivalence using Cmax of total doxorubicin in plasma

  Throughout 15 days after both dosing.

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

  Throughout 15 days after both dosing.

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

  Throughout 15 days after both dosing.

• Assessment of safety

  Troughout 42 days after first dosing

Study Arms (2)

Reference Product - R

ACTIVE COMPARATOR

Doxorubicin 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).

Drug: Doxorubicin Hydrochloride Liposome Injection

Test Product - T

EXPERIMENTAL

Doxorubicin 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).

Drug: Doxorubicin Hydrochloride Liposome Injection

Interventions

Doxorubicin Hydrochloride Liposome Injection DRUG

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

Also known as: Doxorubicin Hydrochloride Liposomal injection 20 mg/10 mL

Reference Product - R; Test Product - T

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• Ayana Pharma Ltd.,: lead
• Lambda Therapeutic Research Ltd.: collaborator

Study Sites (15)

MNJ Institute of Oncology & Regional Cancer Center

Hyderabad, Andhra Pradesh, 500004, India

Location

HCG City Cancer Centre

Vijayawada, Andhra Pradesh, 520002, India

Location

Mahatma Gandhi Cancer Hospital & Research Institute

Visakhapatnam, Andhra Pradesh, 530017, India

Location

Nirmal Hospital Pvt. Ltd.

Surat, Gujarat, 395002, India

Location

Unique Hospital - Multispeciality and Research Institute

Surat, Gujarat, 395002, India

Location

Aman Hospital and Research Center

Vadodara, Gujarat, 390021, India

Location

Kailash Cancer Hospital And Research Center

Vadodara, Gujarat, 391760, India

Location

K R Hospital

Mysore, Karnataka, 570001, India

Location

Apex Wellness Rishikesh Hospital

Nashik, Maharashtra, 422 002, India

Location

HCG Manavata Cancer Centre

Nashik, Maharashtra, 422002, India

Location

Noble Hospital Pvt Ltd.

Pune, Maharashtra, 411013, India

Location

Sparsh Hospitals & Critical Care (P) Ltd.

Bhubaneshwar, Odisha, 751007, India

Location

Sri Ramachandra Medical Centre

Chennai, Tamil Nadu, 600116, India

Location

Saveetha Medical College & Hospital

Chennai, Tamil Nadu, 602105, India

Location

VGM Hospital

Coimbatore, Tamil Nadu, 641005, India

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Rakesh J Patel, MD Pharm

  Lambda Therapeutic Research Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Bioequivalence study

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 24, 2018
• Study Start: August 29, 2018
• Primary Completion: February 8, 2019
• Study Completion: March 7, 2019
• Last Updated: November 20, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (15)