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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01204749
Registration number
NCT01204749
Ethics application status
Date submitted
26/08/2010
Date registered
17/09/2010
Date last updated
15/12/2016
Titles & IDs
Public title
TRINOVA-1: A Study of AMG 386 or Placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer and Fallopian Tube Cancer
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Scientific title
A Phase 3, Randomized, Double-Blind Trial of Weekly Paclitaxel Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
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Secondary ID [1]
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20090508
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Fallopian Tube Cancer
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Ovarian Cancer
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Primary Peritoneal Cancer
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Condition category
Condition code
Cancer
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Ovarian and primary peritoneal
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Cancer
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Womb (Uterine or endometrial cancer)
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Cancer
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0
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Stomach
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AMG 386
Treatment: Drugs - AMG 386 Placebo
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Paclitaxel
Experimental: AMG 386 - Arm A: Paclitaxel 80mg/m2 IV QW and Blinded AMG 386 15mg/kg IV QW
Placebo comparator: AMG 386 Placebo - Arm B: Paclitaxel 80mg/m2 IV QW and Blinded AMG 386 Placebo IV QW
Treatment: Drugs: AMG 386
Weekly Intravenous (IV) AMG 386 15 mg/kg
Treatment: Drugs: AMG 386 Placebo
Weekly Intravenous (IV) placebo 15 mg/kg
Treatment: Drugs: Paclitaxel
Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off)
Treatment: Drugs: Paclitaxel
Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival
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Assessment method [1]
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Timepoint [1]
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8 Months on average
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Secondary outcome [1]
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Overall survival
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Assessment method [1]
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Timepoint [1]
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20 months on average
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Secondary outcome [2]
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Objective Response Rate
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Assessment method [2]
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0
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Timepoint [2]
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From Baseline (if subject has Measurable Disease) until objective response (radiologic)
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Secondary outcome [3]
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Duration of response
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Assessment method [3]
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Timepoint [3]
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From Baseline until progression
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Secondary outcome [4]
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CA-125 response rate per Gynecologic Cancer Intergroup (GCIG) and change in CA-125
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Assessment method [4]
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Timepoint [4]
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From Baseline until CA-125 response
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Secondary outcome [5]
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Incidence of adverse events and significant laboratory abnormalities
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Assessment method [5]
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Timepoint [5]
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8 Months on average
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Secondary outcome [6]
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Pharmacokinetics of AMG 386 (Cmax and Cmin)
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Assessment method [6]
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Timepoint [6]
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Week 1 until week 9 of treatment
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Secondary outcome [7]
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Incidence of the occurrence of anti-AMG 386 antibody formation
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Assessment method [7]
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Timepoint [7]
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Week 1 until maximum of 1-year following last dose of study drug
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Secondary outcome [8]
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Patient reported Health Related Quality of Life (HRQOL) and ovarian cancer related symptoms using Functional Assessment of Cancer Therapy - Ovary questionnaire (FACT-O)
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Assessment method [8]
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Timepoint [8]
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From week 1 until 30-days following last study drug administration
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Secondary outcome [9]
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Overall health status using EuroQOL(EQ-5D)
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Assessment method [9]
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Timepoint [9]
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From week 1 until 30-days following last study drug administration
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Eligibility
Key inclusion criteria
* Female 18 years of age or older at the time the written informed consent is obtained
* Gynecologic Oncology Group (GOG) Performance Status of 0 or 1
* Life expectancy >= 3 months (per investigator opinion)
* Histologically or cytologically documented invasive epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (Subjects with pseudomyxoma , mesothelioma, unknown primary tumor, sarcoma, or neuroendocrine histology, with borderline ovarian cancer, ie, subjects with low malignant potential tumors, and with clear cell or mucinous histology are excluded)
* Subjects must have undergone surgery for ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including at least a unilateral oophorectomy
* Radiologically evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with modifications
* Subjects must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation therapy, bevacizumab or extended therapy administered after surgical or non-surgical assessment.
* Adequate organ and hematological function
* Generally well controlled blood pressure with systolic blood pressure <= 140 mmHg and diastolic blood pressure <= 90 mmHg prior to randomization. The use of anti-hypertensive medications to control hypertension is permitted
* Radiographically documented disease progression either on or following the last dose of prior chemotherapy regimen for epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Subjects who have received more than 3 previous regimens of anti-cancer therapy for epithelial ovarian, primary peritoneal or fallopian tube cancers
* Subjects who have received paclitaxel as consolidation therapy, maintenance, or monotherapy are excluded
* Subjects with primary platinum-refractory disease
* Subjects with platinum-free interval (PFI) > 12 months from their last platinum based therapy
* Radiotherapy <= 14 days prior to randomization. Subjects must have recovered from all radiotherapy-related toxicities
* Previous abdominal or pelvic radiotherapy
* History of arterial or venous thromboembolism within 12 months prior to randomization
* History of clinically significant bleeding within 6 months prior to randomization
* History of central nervous system metastasis
* Has not yet completed a 21 day washout period prior to randomization for any previous anti cancer systemic therapies (30 days for prior bevacizumab)
* Enrolled in or has not yet completed at least 30 days (prior to randomization) since ending other investigational device or drug, or currently receiving other investigational treatments
* Unresolved toxicities from prior systemic therapy that are Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 >= Grade 2 in severity except alopecia
* Known active or ongoing infection (except uncomplicated urinary tract infection [UTI]) within 14 days prior to randomization
* Currently or previously treated with AMG 386, or other molecules that inhibit the angiopoietins or Tie2 receptor
* Treatment within 30 days prior to randomization with strong immune modulators including but not limited to systemic cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, methotrexate, azathioprine, rapamycin, thalidomide, and lenalidomide
* Clinically significant cardiovascular disease within 12 months prior to randomization
* Major surgery within 28 days prior to randomization or still recovering from prior surgery
* Minor surgical procedures, except placement of tunneled central venous access device within 3 days prior to randomization. Diagnostic laparoscopy is regarded as a minor surgical procedure.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2016
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Sample size
Target
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Accrual to date
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Final
919
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Research Site - New Lambton Heights
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Research Site - Parkville
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2305 - New Lambton Heights
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4120 - Greenslopes
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3550 - Bendigo
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3165 - Bentleigh East
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3011 - Footscray
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3144 - Malvern
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Recruitment postcode(s) [7]
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3052 - Parkville
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Recruitment outside Australia
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Lima
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Portugal
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Madrid
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Baden
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Manchester
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Northwood
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Nottingham
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Poole
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United Kingdom
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Funding & Sponsors
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Commercial sector/industry
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Name
Amgen
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Summary
Brief summary
The purpose of this study is to determine if treatment with paclitaxel plus AMG 386 is superior to paclitaxel plus placebo in women with recurrent partially platinum sensitive or resistant epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer. AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.
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Trial website
https://clinicaltrials.gov/study/NCT01204749
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Trial related presentations / publications
Monk BJ, Poveda A, Vergote I, Raspagliesi F, Fujiwara K, Bae DS, Oaknin A, Ray-Coquard I, Provencher DM, Karlan BY, Lhomme C, Richardson G, Rincon DG, Coleman RL, Herzog TJ, Marth C, Brize A, Fabbro M, Redondo A, Bamias A, Tassoudji M, Navale L, Warner DJ, Oza AM. Anti-angiopoietin therapy with trebananib for recurrent ovarian cancer (TRINOVA-1): a randomised, multicentre, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2014 Jul;15(8):799-808. doi: 10.1016/S1470-2045(14)70244-X. Epub 2014 Jun 17. Monk BJ, Poveda A, Vergote I, Raspagliesi F, Fujiwara K, Bae DS, Oaknin A, Ray-Coquard I, Provencher DM, Karlan BY, Lhomme C, Richardson G, Rincon DG, Coleman RL, Marth C, Brize A, Fabbro M, Redondo A, Bamias A, Ma H, Vogl FD, Bach BA, Oza AM. Final results of a phase 3 study of trebananib plus weekly paclitaxel in recurrent ovarian cancer (TRINOVA-1): Long-term survival, impact of ascites, and progression-free survival-2. Gynecol Oncol. 2016 Oct;143(1):27-34. doi: 10.1016/j.ygyno.2016.07.112. Epub 2016 Aug 18. Fujiwara K, Monk BJ, Lhomme C, Coleman RL, Brize A, Oaknin A, Ray-Coquard I, Fabbro M, Provencher D, Bamias A, Vergote I, DeCensi A, Zhang K, Vogl FD, Bach BA, Raspagliesi F. Health-related quality of life in women with recurrent ovarian cancer receiving paclitaxel plus trebananib or placebo (TRINOVA-1). Ann Oncol. 2016 Jun;27(6):1006-1013. doi: 10.1093/annonc/mdw147. Epub 2016 Mar 30.
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Public notes
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Contacts
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MD
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Amgen
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https://clinicaltrials.gov/study/NCT01204749
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