Ovarian CancerPhase 1NCT01715168
A Crossover Bioequivalence Study of Intravenously Administered ATI0918 and DOXIL/CAELYX in Patients With Ovarian Cancer
A Phase 1 study testing DOXIL/CAELYX and ATI-0918 in people with Ovarian Cancer and Malignant Female Reproductive System Neoplasm, run by Azaya Therapeutics, Inc. at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Ovarian Cancer, Malignant Female Reproductive System Neoplasm, Cancer
- What is being tested?
- DOXIL/CAELYX and ATI-0918
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2012to Dec 2015
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have histologically confirmed ovarian cancer that is potentially sensitive to DOXIL/CAELYX
- Have disease progression or recurrence after a maximum of 2 prior chemotherapies, one of which was platinum based.
- Be DOXIL/CAELYX treatment naïve
- Have a normal left ventricular ejection fraction (LVEF) based on institutional ranges.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of </= 2
- Have an estimated life expectancy of ≥ 3 months
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- Be >/= 18 and </= 70 years of age
- Sign a written Institutional Review Board (IRB)-approved informed consent form
- Have a negative pregnancy test, if patient is of child-bearing potential
- Have acceptable liver function:
- Bilirubin </= upper limit of normal (ULN)
- AST (SGOT), ALT (SGPT) and Alkaline phosphatase </= 1.5 times upper limit of normal
- 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.
- Have acceptable hematologic status:
- Neutrophils >/= 1500 cells/mm3
- Platelet count >/= 100,000 (plt/mm3)
- Hemoglobin >/= 9 g/dL
- Have acceptable coagulation status:
- Prothrombin time (PT) or International Normalized Ratio (INR) within 1.5 × ULN
- Partial thromboplastin time (PTT) within 1.5 × ULN
- Agree to use effective contraceptive methods during the study (nonsterile patients of childbearing potential)
Who cannot join
- 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
- Have received > 250 mg/m2 of doxorubicin or equivalent as other anthracyclines or similar compounds
- Have received prior treatment with DOXIL/CAELYX
- Have received radiotherapy to the mediastinal area or concomitant therapy with other potentially cardiotoxic agents
- Have seizure disorders requiring anticonvulsant therapy
- Have known brain metastases (unless previously treated and well controlled for a period of >/= 3 months)
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- Have severe chronic obstructive pulmonary disease with hypoxemia
- Have had major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1
- Have an active, uncontrolled bacterial, viral, fungal, or other opportunistic infections requiring systemic therapy
- 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.
- 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).
- Have received radiation therapy to >25% of her total bone marrow during her lifetime
- Are unwilling or unable to comply with procedures required in this protocol
- Have known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- 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
- Are currently receiving any other investigational agent
- Have exhibited allergic reactions to doxorubicin or a similar structural compound
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Yakima Valley Memorial Hospital - North Star Lodge
Yakima, Washington, 98902
Canada1 site
Centre Hospitalier de L'Universite de Montreal (CHUM)
Montreal, Quebec, H2L4M1
About this study
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
The purpose of this study is to find the answers to the following research question(s):
- 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?
Read more
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).
- Conditions
- Ovarian Cancer, Malignant Female Reproductive System Neoplasm, Cancer, Ovarian Tumor, Ovarian Epithelial Cancer Recurrent
- Being tested
- DOXIL/CAELYX, ATI-0918
- Keywords
- Doxil generic, Caelyx generic, generic treatment, ovarian cancer, ovary, progressed, recurred cancer, platinum based therapy
- Medical subject headings
- Ovarian Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOXIL/CAELYXDrug
Also called Doxorubicin Hydrochloride, Doxil, Caelyx, Liposomal doxorubicin hydrochloride
ATI-0918Drug
Also called doxorubicin hydrochloride, liposomal doxorubicin hydrochloride
| Study group | Role | What they receive |
|---|---|---|
| DOXIL/CAELYX or Doxorubicin Hydrochloride (Lipspome) | Active comparator | Current Standard of care and/or reference product in Europe (Caelyx) and US (Doxorubicin Hydrochloride (Liposome) and Doxil) Receives: Drug: DOXIL/CAELYX |
| ATI-0918 | Experimental | Investigational drug arm which will be compared to Doxil/Caelyx and Hydrochloride Doxorubicin (Liposome) arms for bioequivalence analysis Receives: Drug: ATI-0918 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of AUC in a single dose of ATI0918 vs single dose of Doxil/Caelyx
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.
Measured: 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)
Comparison of Cmax in a single dose of ATI0918 vs single dose of Doxil/Caelyx
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azaya Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715168
- Sponsor's protocol ID
- ATI0918-101
- Status last verified
- Jan 2015
- First submitted
- 19 Oct 2012
- Last updated
- 15 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01715168
- Acronym / sponsor ID
- ATI0918-101
- Conditions
- Ovarian Cancer, Malignant Female Reproductive System Neoplasm, Cancer, Ovarian Tumor, Ovarian Epithelial Cancer Recurrent
- Keywords
- Doxil generic, Caelyx generic, generic treatment, ovarian cancer, ovary, progressed, recurred cancer, platinum based therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Azaya Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 26 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find the answers to the following research question(s):
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DOXIL/CAELYX or Doxorubicin Hydrochloride (Lipspome) | Active comparator | Drug: DOXIL/CAELYXCurrent Standard of care and/or reference product in Europe (Caelyx) and US (Doxorubicin Hydrochloride (Liposome) and Doxil) |
| ATI-0918 | Experimental | Drug: ATI-0918Investigational drug arm which will be compared to Doxil/Caelyx and Hydrochloride Doxorubicin (Liposome) arms for bioequivalence analysis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Have histologically confirmed ovarian cancer that is potentially sensitive to DOXIL/CAELYX
- Have disease progression or recurrence after a maximum of 2 prior chemotherapies, one of which was platinum based.
- Be DOXIL/CAELYX treatment naïve
- Have a normal left ventricular ejection fraction (LVEF) based on institutional ranges.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of </= 2
Key exclusion criteria (17 listed)
- 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
- Have received > 250 mg/m2 of doxorubicin or equivalent as other anthracyclines or similar compounds
- Have received prior treatment with DOXIL/CAELYX
- Have received radiotherapy to the mediastinal area or concomitant therapy with other potentially cardiotoxic agents
- Have seizure disorders requiring anticonvulsant therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DOXIL/CAELYXAlso: Doxorubicin Hydrochloride, Doxil, Caelyx, Liposomal doxorubicin hydrochloride | Drug | DOXIL/CAELYX or Doxorubicin Hydrochloride (Lipspome) |
| ATI-0918Also: doxorubicin hydrochloride, liposomal doxorubicin hydrochloride | Drug | ATI-0918 |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DOXIL/CAELYX and ATI-0918 in people with Ovarian Cancer and Malignant Female Reproductive System Neoplasm, run by Azaya Therapeutics, Inc. at 2 sites in 2 countries.
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 22 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 15 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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?
Results are not available in the source record.
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?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2015; AzTrials last refreshed its copy on 7 Nov 2026.