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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

Phase 1
18 Years
70 Years
Open (Enrolling)
Ovarian Cancer, Malignant Female Reproductive System Neoplasm, Cancer, Ovarian Tumor, Ovarian Epithelial Cancer Recurrent

Thank you

Trial Information

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

Inclusion Criteria:

1. Have histologically confirmed ovarian cancer that is potentially sensitive to

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

5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of
6. Have an estimated life expectancy of ≥ 3 months

7. Be >/= 18 and
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
- AST (SGOT), ALT (SGPT) and Alkaline phosphatase 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Comparison of AUC in a single dose of ATI0918 vs single dose of Doxil/Caelyx

Outcome Description:

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.

Outcome 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)

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

October 2012

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Malignant Female Reproductive System Neoplasm
  • Cancer
  • Ovarian Tumor
  • Ovarian Epithelial Cancer Recurrent
  • Doxil generic
  • Caelyx generic
  • generic treatment
  • ovarian cancer
  • ovary
  • progressed
  • recurred cancer
  • platinum based therapy
  • Neoplasms
  • Genital Neoplasms, Female
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial



University of Pennsylvania Philadelphia, Pennsylvania  19104
Winthrop University Mineola, New York  11501