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- Klinische proef NCT00408603
Safety and Efficacy Clinical Study of SNS-595 in Patients With Platinum-Resistant Ovarian Cancer
A Phase 2 Open-Label, Multicenter Study of SNS-595 Injection in Patients With Platinum-Resistant Ovarian Cancer
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Centre
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British Columbia
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Kelowna, British Columbia, Canada, V1Y 5L3
- BC Cancer Agency at Centre for Southern Interior
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Surrey, British Columbia, Canada, V3V 1Z2
- BC Cancer Agency at Fraser Valley Centre
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Vancouver, British Columbia, Canada, V5Z 4E6
- BC Cancer Agency at Vancouver
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Victoria, British Columbia, Canada, V8R 6V5
- BC Cancer Agency - Vancouver Island Centre
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Juravinski Cancer Centre Department of Oncology
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Arizona
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Scottsdale, Arizona, Verenigde Staten, 85260
- Premiere Oncology of Arizona
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California
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Newport Beach, California, Verenigde Staten, 92663
- Gynecologic Oncology Associates
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San Diego, California, Verenigde Staten, 92123
- Sharp Clinical Oncology Research
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Stanford, California, Verenigde Staten, 94305
- Stanford University
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District of Columbia
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Washington, D.C., District of Columbia, Verenigde Staten, 10010
- Medstar Research Institute at Washington Hospital Center
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Illinois
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Park Ridge, Illinois, Verenigde Staten, 60068
- Oncology Specialists, S.C. at Luthern General Advanced Care Center
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Kentucky
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Louisville, Kentucky, Verenigde Staten, 40202
- Louisville Oncology Clinical Research Program
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21237
- The Harry and Jeanette Weinberg Institute at Franklin Square
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Verenigde Staten, 02114
- Massachusetts General Hospital
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New York
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New York, New York, Verenigde Staten, 10021
- Memorial Sloan Kettering Cancer Center (MSKCC)
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Oregon
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Portland, Oregon, Verenigde Staten, 97227
- Kaiser Permanente NW Region
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Pennsylvania
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Pittsburgh, Pennsylvania, Verenigde Staten, 15213
- University of Pittsburgh Medical Center at Magee-Womens Hospital
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Tennessee
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Knoxville, Tennessee, Verenigde Staten, 37920
- Hall and Martin, MD's, P.C.
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: All study patients
All patients will receive voreloxin injection
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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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Overall Response Rate (CR+PR) Per Investigator Assessment Based on GOG-RECIST Criteria
Tijdsspanne: 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
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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.
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Progression-free Survival (PFS) Using Kaplan-Meier Methods
Tijdsspanne: 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
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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. |
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
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Sunesis Medical Monitor, MD, Sunesis Pharmaceuticals
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per histologisch type
- Neoplasmata
- Urogenitale neoplasmata
- Neoplasmata per site
- Carcinoom
- Neoplasmata, glandulair en epitheel
- Genitale neoplasmata, vrouwelijk
- Endocriene systeemziekten
- Ovariële ziekten
- Adnexale ziekten
- Gonadale aandoeningen
- Endocriene klierneoplasmata
- Ovariumneoplasmata
- Carcinoom, ovariumepitheel
Andere studie-ID-nummers
- SPO-0010
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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Xijing HospitalWerving
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Jiangsu Alphamab Biopharmaceuticals Co., LtdWervingGeavanceerde niet-kleincellige longkankerChina
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Samsung Medical CenterIngetrokkenVloeiende responsiviteit | Neurologische ziekten of aandoeningen | Niet-invasieve cardiale outputbewaking | Grijze ZoneKorea, republiek van
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