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Trial record 23 of 2033 for:    doxil

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

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ClinicalTrials.gov Identifier: NCT01715168
Recruitment Status : Unknown
Verified January 2015 by Azaya Therapeutics, Inc..
Recruitment status was:  Active, not recruiting
First Posted : October 26, 2012
Last Update Posted : January 15, 2015
Sponsor:
Information provided by (Responsible Party):
Azaya Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE October 19, 2012
First Posted Date  ICMJE October 26, 2012
Last Update Posted Date January 15, 2015
Study Start Date  ICMJE October 2012
Estimated Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2012)
  • 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) ]
    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) ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01715168 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Crossover Bioequivalence Study of Intravenously Administered ATI0918 and DOXIL/CAELYX in Patients With Ovarian Cancer
Official Title  ICMJE 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
Brief Summary

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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Ovarian Cancer
  • Malignant Female Reproductive System Neoplasm
  • Cancer
  • Ovarian Tumor
  • Ovarian Epithelial Cancer Recurrent
Intervention  ICMJE
  • Drug: DOXIL/CAELYX
    Other Names:
    • Doxorubicin Hydrochloride
    • Doxil
    • Caelyx
    • Liposomal doxorubicin hydrochloride
  • Drug: ATI-0918
    Other Names:
    • doxorubicin hydrochloride
    • liposomal doxorubicin hydrochloride
Study Arms  ICMJE
  • Active Comparator: DOXIL/CAELYX or Doxorubicin Hydrochloride (Lipspome)
    Current Standard of care and/or reference product in Europe (Caelyx) and US (Doxorubicin Hydrochloride (Liposome) and Doxil)
    Intervention: Drug: DOXIL/CAELYX
  • Experimental: ATI-0918
    Investigational drug arm which will be compared to Doxil/Caelyx and Hydrochloride Doxorubicin (Liposome) arms for bioequivalence analysis
    Intervention: Drug: ATI-0918
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 24, 2012)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01715168
Other Study ID Numbers  ICMJE ATI0918-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Azaya Therapeutics, Inc.
Study Sponsor  ICMJE Azaya Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Azaya Therapeutics, Inc.
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP