A Crossover Bioequivalence Study of Intravenously Administered ATI0918 and DOXIL/CAELYX in Patients With Ovarian Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Azaya Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
Azaya Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01715168
First received: October 19, 2012
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to find the answers to the following research question(s):

1. Is the study drug equivalent to the approved drug, Doxil/Caelyx, and does it act the same way in the body as the approved drug?

ATI-0918 is believed to be a generic of Doxil/Caelyx and this is what the study is trying to prove. All people who participate in this study will receive the research study medication (ATI-0918) and Doxil/Caelyx in addition to best supportive care (treatment for symptoms).

The study drug being tested in this study works the same as the FDA (government) approved drug doxorubicin HCl. ATI-0918 is a generic (the same) formulation of doxorubicin HCl being delivered (given to the patient).


Condition Intervention Phase
Ovarian Cancer
Malignant Female Reproductive System Neoplasm
Cancer
Ovarian Tumor
Ovarian Epithelial Cancer Recurrent
Drug: DOXIL/CAELYX
Drug: ATI-0918
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Single-blind, Randomized, Two-way, Crossover Bioequivalence Study of Intravenously Administered ATI 0918 in Patients With Ovarian Cancer That Has Progressed or Recurred After Platinum-based Chemotherapy

Resource links provided by NLM:


Further study details as provided by Azaya Therapeutics, Inc.:

Primary Outcome Measures:
  • Comparison of AUC in a single dose of ATI0918 vs single dose of Doxil/Caelyx [ Time Frame: pre, 30 min + pre, 0, .50, 1, 2, 4, 6, 24, 48, 72, 120, 168, 216 hour post infusion for 2 Cycles (Cycle is defined as 28 days) ] [ Designated as safety issue: No ]
    The primary objective of this study is to determine the pharmacokinetic equivalence of ATI-0918 and DOXIL/CAELYX as a single dose in patients with ovarian cancer. The outcome measure will be determined by analyzing PK data from drawn from each patient at pre-specified time points and calculating Area under the curve (AUC) and Peak Plasma Concentration (Cmax)to determine % variability between ATI0918 and Doxil/Caelyx within each patient.

  • Comparison of Cmax in a single dose of ATI0918 vs single dose of Doxil/Caelyx [ Time Frame: pre, 30 min + pre, 0, .50, 1, 2, 4, 6, 24, 48, 72, 120, 168, 216 hour post infusion for 2 Cycles (Cycle is defined as 28 days) ] [ Designated as safety issue: No ]
    The primary objective of this study is to determine the pharmacokinetic equivalence of ATI-0918 and DOXIL/CAELYX as a single dose in patients with ovarian cancer. The outcome measure will be determined by analyzing PK data from drawn from each patient at pre-specified time points and calculating Area under the curve (AUC) and Peak Plasma Concentration (Cmax)to determine % variability between ATI0918 and Doxil/Caelyx within each patient.


Estimated Enrollment: 40
Study Start Date: October 2012
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: DOXIL/CAELYX Drug: DOXIL/CAELYX
Other Names:
  • Doxorubicin Hydrochloride
  • Doxil
  • Caelyx
  • Liposomal doxorubicin hydrochloride
Experimental: ATI-0918
Investigational drug arm which will be compared to Doxil/Caelyx arm for bioequivalence analysis
Drug: ATI-0918
Other Names:
  • doxorubicin hydrochloride
  • liposomal doxorubicin hydrochloride

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have histologically confirmed ovarian cancer that is potentially sensitive to DOXIL/CAELYX
  2. Have disease progression or recurrence after a maximum of 2 prior chemotherapies, one of which was platinum based.
  3. Be DOXIL/CAELYX treatment naïve
  4. Have a normal left ventricular ejection fraction (LVEF) based on institutional ranges.
  5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of </= 2
  6. Have an estimated life expectancy of ≥ 3 months
  7. Be >/= 18 and </= 70 years of age
  8. Sign a written Institutional Review Board (IRB)-approved informed consent form
  9. Have a negative pregnancy test, if patient is of child-bearing potential
  10. Have acceptable liver function:

    • Bilirubin </= upper limit of normal (ULN)
    • AST (SGOT), ALT (SGPT) and Alkaline phosphatase </= 1.5 times upper limit of normal
  11. Have acceptable renal function:

    • Serum creatinine within normal limits, OR calculated creatinine clearance >/= 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
  12. Have acceptable hematologic status:

    • Neutrophils >/= 1500 cells/mm3
    • Platelet count >/= 100,000 (plt/mm3)
    • Hemoglobin >/= 9 g/dL
  13. Have acceptable coagulation status:

    • Prothrombin time (PT) or International Normalized Ratio (INR) within 1.5 × ULN
    • Partial thromboplastin time (PTT) within 1.5 × ULN
  14. Agree to use effective contraceptive methods during the study (nonsterile patients of childbearing potential)

Exclusion Criteria:

  1. Have New York Heart Association (NYHA) Class III or IV cardiac disease, myocardial infarction within the past 6 months prior to Day 1, unstable arrhythmia, or evidence of ischemia on electrocardiogram (ECG) or during Cardiac Stress Testing within 14 days prior to Day 1
  2. Have received > 250 mg/m2 of doxorubicin or equivalent as other anthracyclines or similar compounds
  3. Have received prior treatment with DOXIL/CAELYX
  4. Have received radiotherapy to the mediastinal area or concomitant therapy with other potentially cardiotoxic agents
  5. Have seizure disorders requiring anticonvulsant therapy
  6. Have known brain metastases (unless previously treated and well controlled for a period of >/= 3 months)
  7. Have severe chronic obstructive pulmonary disease with hypoxemia
  8. Have had major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1
  9. Have an active, uncontrolled bacterial, viral, fungal, or other opportunistic infections requiring systemic therapy
  10. Are pregnant or nursing. NOTE: Nonsterile women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
  11. Have received treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within one month prior to study entry (6 weeks for nitrosoureas or Mitomycin C).
  12. Have received radiation therapy to >25% of her total bone marrow during her lifetime
  13. Are unwilling or unable to comply with procedures required in this protocol
  14. Have known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  15. 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
  16. Are currently receiving any other investigational agent
  17. Have exhibited allergic reactions to doxorubicin or a similar structural compound
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715168

Contacts
Contact: Lee Adkins 919.917.7036 ladkins@ockham.com
Contact: Marla Morris 918.224.2148 mmorris@ockham.com

Locations
United States, New York
Winthrop University Recruiting
Mineola, New York, United States, 11501
Contact: Elena Crespo    516-663-2018    ecrespo@winthrop.org   
Principal Investigator: Jeannine Villella, DO         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kathleen Harlacker, RN    215-662-7730    kathleen.harlacker@uphs.upenn.edu   
Principal Investigator: Christina Chu, MD         
Sponsors and Collaborators
Azaya Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Azaya Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01715168     History of Changes
Other Study ID Numbers: ATI0918-101
Study First Received: October 19, 2012
Last Updated: January 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Azaya Therapeutics, Inc.:
Doxil generic
Caelyx generic
generic treatment
ovarian cancer
ovary
progressed
recurred cancer
platinum based therapy

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms
Genital Neoplasms, Female
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014