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SGI-110 in Combination With Carboplatin in Ovarian Cancer (SGI-110)

30. april 2021 opdateret af: Astex Pharmaceuticals, Inc.

A Randomized, Controlled, Open-Label, Phase 2 Trial of SGI-110 and Carboplatin in Subjects With Platinum-Resistant Recurrent Ovarian Cancer

A 2-part, Phase 2 controlled, open-label, randomized study in participants with platinum-resistant recurrent ovarian cancer. In Part 1, participants received SGI-110 and carboplatin. The optimum dose of SGI-110 (guadecitabine) was identified in Part 1 based on safety and efficacy. In Part 2, participants were randomized to receive the dose identified in Part 1 plus carboplatin or one of four treatment of choice at the discretion of the investigator. The treatment of choice consisted of topotecan, pegylated liposomal doxorubicin, paclitaxel or gemcitabine.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

120

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • CHUM Gynecologie-Oncologie, Notre Dame Hospital
  • Det Forenede Kongerige
      • Bristol, Det Forenede Kongerige, BS2 8ED
        • Bristol Heamatology and Oncology Centre
      • Leeds, Det Forenede Kongerige, LS9 7TF
        • St. James Univesity Hospital - St. James Institute of Oncology
      • London, Det Forenede Kongerige, EC1V 4AD
        • Cambridge University Hospitals NHS Foundation and Trust
      • London, Det Forenede Kongerige, NW1 2PG
        • Univesity College Hospital
      • London, Det Forenede Kongerige, W12 0NN
        • Imperial College Health Care NHS Trust-Garry Weston Centre
      • Middlesex, Det Forenede Kongerige, HA6 2RN
        • Mount Vernon Cancer Centre
      • Sutton, Det Forenede Kongerige, SM2 5PT
        • Royal Marsden Foundation Trust
  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90033
        • Norris Comprehensive Cancer Center- University of Southern California
    • Florida
      • Gainesville, Florida, Forenede Stater, 32610
        • University of Florida Shands Cancer Center
    • Georgia
      • Augusta, Georgia, Forenede Stater, 30912
        • Georgia Health Sciences University
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Melvin and Bren Simon Cancer Center- Indiana University
    • Louisiana
      • Covington, Louisiana, Forenede Stater, 70433
        • Women's Cancer Care
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21231
        • Johns Hopkins Kimmel Cancer Center
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Dana Farber Cancer Institute
    • New York
      • Brightwaters, New York, Forenede Stater, 11718
        • Island Gynecologic Oncology
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke Cancer Institute- Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45267
        • University of Cincinnati Cancer Institute
    • Texas
      • Dallas, Texas, Forenede Stater, 75201
        • Mary Crowley Medical Research Center
    • Virginia
      • Falls Church, Virginia, Forenede Stater, 22042
        • Inova Fairfax Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  1. Participants who are women 18 years of age or older.
  2. Participants who have histologically or cytologically confirmed recurrent high-grade serous epithelial ovarian cancer (Grade 2 or 3), primary peritoneal carcinomatosis or fallopian tube cancer.
  3. Participants who have platinum-resistant disease (defined as having relapsed within 6 months of her last platinum-containing regimen). There is no limit on the number of prior treatment regimens in Part 1. In Part 2, participants may have had no more than 3 prior cytotoxic treatment regimens, excluding adjuvant or maintenance therapy.
  4. Participants must have had prior paclitaxel treatment.
  5. Participants who have measurable disease according to RECIST v1.1 or detectable disease.
  6. Participants with ECOG performance status of 0 or 1.
  7. Participants with acceptable organ function.
  8. Participants must be at least 3 weeks from last chemotherapy.

Exclusion Criteria:

  1. Participants who have hypersensitivity to SGI-110 and/or carboplatin or other components of these drug products.
  2. Participants who have received prior therapy with any hypomethylating agents.
  3. Participants who are refractory to platinum treatment i.e., progressed while on platinum treatment.
  4. Participants with abnormal left ventricular ejection fraction.
  5. Participants with Grade 2 or greater neuropathy.
  6. Participants with known brain metastases.
  7. Participants with known history of HIV, HCV or HBV.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: SGI-110 + Carboplatin
Stage 1 was a safety lead-in stage with a dose escalation design. Participants were evaluated with the combination of SGI-110 (guadecitabine) plus carboplatin (G+C), given as 28-day treatment cycles: guadecitabine administered subcutaneous (SC) daily on Days 1-5, at a starting dose of 45 mg/m2/day in Cohort 1, followed by carboplatin intravenous (IV) based on a targeted dose of area under the curve (AUC) 5 on Day 8. After dose limiting toxicities were noted, guadecitabine dose was reduced to 30 mg/m2/day for subsequent cycles for 4 participants. Cohort 2 received 30 mg/m2/day guadecitabine and carboplatin IV AUC 4.
Medicin: Carboplatin
Medicin: SGI-110
Andre navne:
  • guadecitabin
Eksperimentel: SGI-110 + Carboplatin or TC
Stage 2 was an open-label, randomized, controlled trial. Eligible participants were randomly assigned in a 1:1 ratio to receive either (1) G+C combination treatment in 28-day cycles at 30 mg/m2 SC once daily on Days 1-5 and carboplatin IV AUC 4 on Day 8, or (2) treatment of choice (TC) of topotecan, pegylated liposomal doxorubicin (PLD), paclitaxel, or gemcitabine based on recommended dosing in 28-day cycles; participants initially randomized to TC were able to cross over to receive 30 mg/m2 G+C due to disease progression.
Medicin: Carboplatin
Medicin: SGI-110
Andre navne:
  • guadecitabin
Medicin: Treatment of Choice (topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine)
Investigator chose to treat with either topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Stage 1: Dose Limiting Toxicities
Tidsramme: Up to 12 months
Number of participants with dose limiting toxicities (DLTs) in Stage 1
Up to 12 months
Stage 2: Progression Free Survival
Tidsramme: Up to 24 months
Progression free survival (PFS) time was defined as the time interval from the date of the first dose of study medication until the earlier of disease progression or death. Participants were treated with their assigned treatment [guadecitabine+carboplatin (G+C) or treatment choice (TC)] until disease progression or unacceptable treatment-related toxicity occurred.
Up to 24 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective Response Rate
Tidsramme: Up to 24 months
The objective response rate (ORR) was defined as the proportion of participants who experienced an objective response (best overall response of complete response/full response or partial response, which was confirmed by a subsequent assessment at least 28 days later). Response categories were determined based on RECIST v1.1 criteria, or on modified Rustin (CA-125) criteria if response assessment could not be made using RECIST criteria.
Up to 24 months
Progression Free Survival at 6 Months
Tidsramme: 6 months
Progression free survival rate at 6 months is the proportion of participants who were alive and did not have disease progression at 6 months after start of treatment.
6 months
Clinical Benefit Rate
Tidsramme: Up to 24 months
Clinical benefit rate (CBR) was defined as the proportion of subjects who experienced a best overall response of complete response/full response or partial response (confirmed by a subsequent assessment at least 28 days later), or documented stable disease for at least 3 months after the first dose. Response categories were determined based on RECIST v1.1 criteria, then based on modified Rustin (CA-125) criteria if assessment could not be made using RECIST criteria.
Up to 24 months
CA-125 Levels
Tidsramme: Up to 24 months
Percentage of participants with CA-125 reduction by ≥ 50% from baseline
Up to 24 months
Duration of Response
Tidsramme: Up to 24 months
Duration of response is defined as the time between the date of the first documentation of complete response/full response or partial response, and the date of disease progression or date of death due to any cause, or the last adequate tumor assessment prior to the start of subsequent anti-cancer therapy including crossing over to G+C from TC arm, whichever occurred earlier. Only participants who responded were included in the duration of response calculation.
Up to 24 months
Overall Survival
Tidsramme: Up to 24 months
Overall survival was defined as the number of days from the day the participant was administered the first dose of study treatment to the date of death (regardless of cause). Survival time was censored on the last date the participant was known to be alive or lost to follow-up before reaching the event of death; in the TC group, time was censored at the date of crossover.
Up to 24 months
Stage 1: Pharmacokinetic Parameter Cmax
Tidsramme: Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)
Time to maximum plasma concentration for guadecitabine, decitabine and carboplatin
Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)
Stage 1: Pharmacokinetic Parameter Tmax
Tidsramme: Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)
Time to last measurable concentration for guadecitabine, decitabine and carboplatin
Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)
Stage 1: Pharmacokinetic Parameter AUC0-8
Tidsramme: Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)
Area under the concentration-time curve from 0 to 8 hours (AUC0-8) for guadecitabine, decitabine and carboplatin
Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Astex Pharmaceuticals, Inc.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2012

Primær færdiggørelse (Faktiske)

1. august 2016

Studieafslutning (Faktiske)

1. august 2016

Datoer for studieregistrering

Først indsendt

26. september 2012

Først indsendt, der opfyldte QC-kriterier

27. september 2012

Først opslået (Skøn)

28. september 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. maj 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. april 2021

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SGI-110-02

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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