Epithelial Ovarian CancerPhase 2NCT00408603
Safety and Efficacy Clinical Study of SNS-595 in Patients With Platinum-Resistant Ovarian Cancer
A Phase 2 study testing Voreloxin Injection in people with Epithelial Ovarian Cancer, run by Sunesis Pharmaceuticals at 20 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the objective response rate, safety and identify potential biomarkers in platinum-resistant ovarian cancer patients treated with voreloxin injection given on a 28-day cycle. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer
- What is being tested?
- Voreloxin Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 20 Dec 2006to 9 Jun 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically documented epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer
- Completed at least one Platinum Based Therapy (PBT) regimen (carboplatin, cisplatin, or another organoplatinum compound).
- Evidence of platinum-resistant disease, relapse/progression within 6 months of the completion of PBT, or intolerant to PBT (inability to receive PBT due to hypersensitivity reactions to platinum)
- Patients with primary platinum-resistant disease are allowed to receive no more than one nonplatinum cytotoxic regimen and no more than one noncytotoxic regimen for the management of recurrent or persistent disease after the development of primary platinum-resistance.
- Measurable disease per GOG-RECIST criteria
- GOG Performance Status of 0 or 1
Who cannot join
- Radiotherapy, chemotherapy, and hormonal, cytokine, or targeted therapy, within 3 weeks (nitrosurea or mitomycin C within 6 weeks) prior to the anticipated first day of treatment.
- Monoclonal antibody therapy within 4 weeks prior to clinical study entry
- Unresolved or impending bowel obstruction
- Other active malignancies or other malignancies within the last 12 months except nonmelanoma skin cancer or cervical intraepithelial neoplasia
- Prior radiotherapy to more than 25% of the marrow space
- Requiring hemodialysis or peritoneal dialysis
Show all 11Show fewer
- Myocardial infarction or cerebrovascular accident/transient ischemic attack within the 6 months prior to the anticipated first day of treatment
- Thromboembolic event (deep vein thrombosis [DVT] or pulmonary embolus [PE]) within 28 days prior to the anticipated first day of treatment
- History of active CNS metastases
- Any other medical, psychological, or social condition that would contraindicate the patient's participation in the clinical study due to safety or compliance with clinical study procedures.
- Please note: There are additional inclusion/exclusion criteria for this study. Please contact the study center for additional information and to determine if you meet all study criteria.
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States14 sites
The Harry and Jeanette Weinberg Institute at Franklin Square
Baltimore, Maryland, 21237
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Hall and Martin, MD's, P.C.
Knoxville, Tennessee, 37920
Louisville Oncology Clinical Research Program
Louisville, Kentucky, 40202
Memorial Sloan Kettering Cancer Center (MSKCC)
New York, New York, 10021
Gynecologic Oncology Associates
Newport Beach, California, 92663
Oncology Specialists, S.C. at Luthern General Advanced Care Center
Park Ridge, Illinois, 60068
University of Pittsburgh Medical Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
Kaiser Permanente NW Region
Portland, Oregon, 97227
Sharp Clinical Oncology Research
San Diego, California, 92123
Premiere Oncology of Arizona
Scottsdale, Arizona, 85260
Stanford University
Stanford, California, 94305
Medstar Research Institute at Washington Hospital Center
Washington D.C., District of Columbia, 10010
Canada6 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Juravinski Cancer Centre Department of Oncology
Hamilton, Ontario, L8V 5C2
BC Cancer Agency at Centre for Southern Interior
Kelowna, British Columbia, V1Y 5L3
BC Cancer Agency at Fraser Valley Centre
Surrey, British Columbia, V3V 1Z2
BC Cancer Agency at Vancouver
Vancouver, British Columbia, V5Z 4E6
BC Cancer Agency - Vancouver Island Centre
Victoria, British Columbia, V8R 6V5
About this study
Official title: A Phase 2 Open-Label, Multicenter Study of SNS-595 Injection in Patients With Platinum-Resistant Ovarian Cancer
The purpose of this study is to evaluate the objective response rate, safety and identify potential biomarkers in platinum-resistant ovarian cancer patients treated with voreloxin injection given on a 28-day cycle.
Read the detailed description
Other objectives of this study are to evaluate Progression-free survival and measure CA-125 response rate.
- Conditions
- Epithelial Ovarian Cancer
- Being tested
- Voreloxin Injection
- Keywords
- second line treatment, platinum resistant, ovary, ovaries, cancer, epithelial, carcinomas, tumor
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voreloxin InjectionDrug
Also called SNS-595, vosaroxin, Qinprezo
All patients in initial dose level receive voreloxin injection at 48 mg/m2 administered once every 21 days up to 6 cycles. Subsequent levels are of 60 mg/m2 or 75 mg/m2 every 28 days up to 6 cycles if safety acceptable.
| Study group | Role | What they receive |
|---|---|---|
| All study patients | Experimental | All patients will receive voreloxin injection Receives: Drug: Voreloxin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (CR+PR) Per Investigator Assessment Based on GOG-RECIST Criteria
Response rate was calculated per investigator's tumor assessment based on GOG-RECIST, which includes radiographic imaging, physical examination results, and CA-125 levels. No independent review of CT scans (lesion assessments) was performed. CR: disappearance of all target and nontarget lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Normalization of CA125, if elevated at baseline, is required for ovarian carcinoma studies. PR is >= 30% decrease in the sum of LD of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required.
Measured: GOG-RECIST assessment obtained on cycle2, 4 and 6 Day 21for patients treated with 48 mg/m2 SNS-595 and Day 28 for patients treated with 60 mg/m2, through 28 (±14) days afte the last treatment at the end of safety follow up period
Secondary outcomes (1)
Progression-free Survival (PFS) Using Kaplan-Meier Methods
PFS is the the time between the date the patient first received Vosaroxin and the earliest date of disease progression.
For patients who experienced disease progression, the date of disease progression will be the earliest date on which disease progression is indicated based on the rules.
For patients who died with no indication of disease progression, the date of death will be the earliest date on which death is documented based on the rules.
For patients who have no indication of disease progression or death, the censoring date will be the Date of Confirmed Contact from the last Survival Follow-Up CRF, or if not in survival follow-up, then the Assessment Date from the last GOG-RECIST CRF, or if no response assessment available, Date of Last Visit / Contact from Extended Treatment Completion CRF if in extended treatment, or from Cycle 6 Completion / Early Termination CRF if not in extended treatment.
Measured: From the first teratment of Vosaroxin to the end of Cycle 6 or 28 days after the last treatment at the end of safety follow up period if continued in the extended treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2006 (estimated)
- Study start20 Dec 2006
- Primary completion9 Jun 2010
- Study completion9 Jun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Epithelial 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunesis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sunesis Medical Monitor, MD, Study director, Sunesis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408603
- Sponsor's protocol ID
- SPO-0010
- Status last verified
- Jun 2017
- First submitted
- 5 Dec 2006
- Last updated
- 27 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data of individual participants experiencing Serious Adverse Events, post trial completion
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-Label, Multicenter Study of SNS-595 Injection in Patients With Platinum-Resistant Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00408603
- Acronym / sponsor ID
- SPO-0010
- Conditions
- Epithelial Ovarian Cancer
- Keywords
- second line treatment, platinum resistant, ovary, ovaries, cancer, epithelial, carcinomas, tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Sunesis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2006 (actual)
- Primary completion
- 9 Jun 2010 (actual)
- Study completion
- 9 Jun 2010 (actual)
- First posted
- 7 Dec 2006 (estimated)
- Results
- Posted 28 Jun 2017
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 evaluate the objective response rate, safety and identify potential biomarkers in platinum-resistant ovarian cancer patients treated with voreloxin injection given on a 28-day cycle.
Detailed description
Other objectives of this study are to evaluate Progression-free survival and measure CA-125 response rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All study patients | Experimental | Drug: Voreloxin InjectionAll patients will receive voreloxin injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically documented epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer
- Completed at least one Platinum Based Therapy (PBT) regimen (carboplatin, cisplatin, or another organoplatinum compound).
- Evidence of platinum-resistant disease, relapse/progression within 6 months of the completion of PBT, or intolerant to PBT (inability to receive PBT due to hypersensitivity reactions to platinum)
- Patients with primary platinum-resistant disease are allowed to receive no more than one nonplatinum cytotoxic regimen and no more than one noncytotoxic regimen for the management of recurrent or persistent disease after the development of primary platinum-resistance.
- Measurable disease per GOG-RECIST criteria
Key exclusion criteria (11 listed)
- Radiotherapy, chemotherapy, and hormonal, cytokine, or targeted therapy, within 3 weeks (nitrosurea or mitomycin C within 6 weeks) prior to the anticipated first day of treatment.
- Monoclonal antibody therapy within 4 weeks prior to clinical study entry
- Unresolved or impending bowel obstruction
- Other active malignancies or other malignancies within the last 12 months except nonmelanoma skin cancer or cervical intraepithelial neoplasia
- Prior radiotherapy to more than 25% of the marrow space
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 |
|---|---|---|
| Voreloxin InjectionAlso: SNS-595, vosaroxin, QinprezoAll patients in initial dose level receive voreloxin injection at 48 mg/m2 administered once every 21 days up to 6 cycles. Subsequent levels are of 60 mg/m2 or 75 mg/m2 every 28 days up to 6 cycles if safety acceptable. | Drug | All study patients |
Primary outcome
Overall Response Rate (CR+PR) Per Investigator Assessment Based on GOG-RECIST Criteria
Time frame: GOG-RECIST assessment obtained on cycle2, 4 and 6 Day 21for patients treated with 48 mg/m2 SNS-595 and Day 28 for patients treated with 60 mg/m2, through 28 (±14) days afte the last treatment at the end of safety follow up period
Response rate was calculated per investigator's tumor assessment based on GOG-RECIST, which includes radiographic imaging, physical examination results, and CA-125 levels. No independent review of CT scans (lesion assessments) was performed. CR: disappearance of all target and nontarget lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Normalization of CA125, if elevated at baseline, is required for ovarian carcinoma studies. PR is >= 30% decrease in the sum of LD of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required.
1 secondary outcome
Progression-free Survival (PFS) Using Kaplan-Meier Methods
Time frame: From the first teratment of Vosaroxin to the end of Cycle 6 or 28 days after the last treatment at the end of safety follow up period if continued in the extended treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified data of individual participants experiencing Serious Adverse Events, post trial completion
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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.
Sunesis Medical Monitor, MD study director
Sunesis Pharmaceuticals
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Voreloxin Injection in people with Epithelial Ovarian Cancer, run by Sunesis Pharmaceuticals at 20 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Response Rate (CR+PR) Per Investigator Assessment Based on GOG-RECIST Criteria (time frame: GOG-RECIST assessment obtained on cycle2, 4 and 6 Day 21for patients treated with 48 mg/m2 SNS-595 and Day 28 for patients treated with 60 mg/m2, through 28 (±14) days afte the last treatment at the end of safety follow up period). 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 27 Jul 2017.