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Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer

10. oktober 2017 oppdatert av: Tarix Pharmaceuticals

Ph IIb Study Evaluating the Safety & Efficacy of TXA127 in the Reduction of Incidence and Severity of Thrombocytopenia in Patients Receiving Combination Gemcitabine and Platinum Therapy for Ovarian, Fallopian Tube, or Peritoneal Carcinoma

This research study will investigate the safety and effectiveness of two different dose levels of a new, unapproved drug to be given along with the chemotherapy regimens gemcitabine and carboplatin or gemcitabine and cisplatin prescribed to women for the treatment of ovarian cancer. This experimental drug is called TXA127 and is being tested for effectiveness to see if it will help reduce some of the side effects of the chemotherapy, primarily low blood platelet levels that lead to excess bleeding. This study also intends to test the safety of TXA127 when given as an injection under the skin on a daily basis concurrently with up to 6 cycles of the prescribed chemotherapy.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled study comparing safety and efficacy of two dose levels of TXA127 when administered during 6 cycles of combination gemcitabine and platinum-based chemotherapy. This study intends to investigate the effectiveness of TXA127 for the mitigation of severity and/or incidence of thrombocytopenia, as well as safety when administered as a self-injected, subcutaneous solution.

Females 18 years of age or older with a confirmed diagnosis of ovarian carcinoma who are scheduled to undergo combination chemotherapy with gemcitabine and carboplatin or gemcitabine and cisplatin will be considered for this study. Subjects may be chemotherapy naïve, newly diagnosed, or post a single course of chemotherapy followed by a progression- and treatment-free interval of at least 3 months, or post 2 or more previous courses of chemotherapy after a progression- and treatment-free interval of at least 6 months.

Subjects will be randomized in a 1:1:1 ratio to one of the following three blinded treatment groups: placebo, 100 ug/kg/day TXA127 and 300 ug/kg/day TXA127.

Treatment will be concurrent with up to six consecutive 21-day cycles of one of the following gemcitabine and platin regimens:

Regimen A

  • Intravenous cisplatin therapy at a dose of 30-50 mg/m2 given on Day 1 of the cycle
  • Intravenous gemcitabine at a dose of 800 mg/m2 given on Day 1 after cisplatin and on Day 8 of the cycle.

Regimen B

  • Intravenous gemcitabine at a dose of 1000 mg/m2 given on Days 1 and 8 of the cycle
  • Intravenous carboplatin AUC 4 given after gemcitabine on Day 1 of the cycle

TXA127 will be self-administered as a subcutaneous injection by the subject once daily on Days 2-6 and 9-15 during each cycle of chemotherapy. Blood specimens will be drawn for hematologic analysis on Days 1, 8 and 15 of each treatment cycle.

Studietype

Intervensjonell

Registrering (Faktiske)

34

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Alabama
      • Mobile, Alabama, Forente stater, 36604
        • University of Southern Alabama Mitchell Cancer Institute
    • California
      • Los Angeles, California, Forente stater, 90033
        • USC - LAC Medical Center
      • Orange, California, Forente stater, 92868
        • University of California - Irvine, Chao Family Comprehensive Cancer Center
    • Illinois
      • Chicago, Illinois, Forente stater, 60612
        • Rush University Medical Center
    • Kansas
      • Wichita, Kansas, Forente stater, 67208
        • Associates in Women's Health
    • New York
      • Brightwaters, New York, Forente stater, 11718
        • Schwartz Gynecologic Oncology, PLLC

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • Females at least 18 years of age with ovarian carcinoma who are one of the following:

    • Newly diagnosed with ovarian cancer and chemotherapy naïve, or
    • Post a single previous course of chemotherapy, with a 3-month disease-progression and treatment-free interval, with the exception of antibody therapy, prior to the study screening visit, or
    • Post two or more previous courses of chemotherapy with a 6-month disease-progression and treatment-free interval, with the exception of antibody therapy, prior to the study screening visit.
  • Must be scheduled for a course of combination chemotherapy consisting of gemcitabine and cisplatin or gemcitabine and carboplatin to be administered in 21-day cycles
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  • Adequate bone marrow, renal, and hepatic functions as measured by standard chemistry and hematology blood tests
  • Adequate blood coagulation parameters as measured by standard blood tests for coagulation

Exclusion Criteria:

  • Any clinical or laboratory abnormality greater than Grade 2 toxicity (NCI criteria), with the exception of laboratory parameters specified in the inclusion criteria
  • Significant unstable cardiovascular disease
  • Uncontrolled high blood pressure
  • Current use of an angiotensin converting enzyme (ACE) inhibitor or angiotensin II antagonists
  • Evidence of metastatic disease to the bone
  • Metastatic disease to the CNS requiring treatment or radiation therapy
  • Uncontrolled infection(s)
  • Radiation therapy or chemotherapy (except as specified in the inclusion criteria) within the previous 5 years
  • Concurrent use of hematopoietic or erythropoietic agents

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Combination gemcitabine and platinum-based chemotherapy with concurrent placebo
Legemiddel: Placebo
Once daily subcutaneous injection of placebo
Eksperimentell: TXA127 100 ug/kg
Combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
Legemiddel: TXA127
Once daily subcutaneous injection of 100 ug/kg
Andre navn:
  • Angiotensin 1-7
Legemiddel: TXA127
Once daily subcutaneous injection of 300 ug/kg
Andre navn:
  • Angiotensin 1-7
Eksperimentell: TXA127 300 ug/kg
Combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
Legemiddel: TXA127
Once daily subcutaneous injection of 100 ug/kg
Andre navn:
  • Angiotensin 1-7
Legemiddel: TXA127
Once daily subcutaneous injection of 300 ug/kg
Andre navn:
  • Angiotensin 1-7

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Chemotherapy Cycles During Which the Platelet Count Measures Below 50,000/mm3
Tidsramme: During a maximum of six 3-week chemotherapy cycles
Mean percentage of cycles with platelet counts below 50,000/mm3
During a maximum of six 3-week chemotherapy cycles

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Subjects With Platelet Counts Below 50,000/mm3
Tidsramme: During a maximum of six 3-week chemotherapy cycles
Number of subjects who experienced a platelet count below 50,000/mm3
During a maximum of six 3-week chemotherapy cycles
Treatment Cycles With Platelets Counts Below 25,000/mm3
Tidsramme: During a maximum of six 3-week chemotherapy cycles
Mean percentage of treatment cycles where platelets counts were below 25,000/mm3
During a maximum of six 3-week chemotherapy cycles
Chemotherapy Dose Intensity and Dose Density
Tidsramme: During a maximum of six 3-week chemotherapy cycles
Mean percentage of cycles where projected (target) chemotherapy dose was maintained
During a maximum of six 3-week chemotherapy cycles
Lymphopenia as Determined by Lymphocyte Count
Tidsramme: During a maximum of six 3-week chemotherapy cycles
Number of subjects with a treatment emergent adverse event of lymphopenia
During a maximum of six 3-week chemotherapy cycles
Neutropenia
Tidsramme: During a maximum of six 3-week chemotherapy cycles
Number of subjects with a treatment emergent adverse event of neutropenia
During a maximum of six 3-week chemotherapy cycles
Anemia
Tidsramme: During a maximum of six 3-week chemotherapy cycles
Number of subjects with a treatment emergent adverse event of anemia
During a maximum of six 3-week chemotherapy cycles
Mucositis
Tidsramme: During a maximum of six 3-week chemotherapy cycles
Number of subjects with a treatment emergent adverse event of mucositis
During a maximum of six 3-week chemotherapy cycles
Alopecia
Tidsramme: During a maximum of six 3-week chemotherapy cycles
Number of subjects with a treatment emergent adverse event of alopecia
During a maximum of six 3-week chemotherapy cycles
Rescue Treatment for Hematopoiesis and Mucositis
Tidsramme: During a maximum of six 3-week chemotherapy cycles

Number of subjects with a treatment emergent adverse event of hematopoiesis and mucositis who received rescue treatment as determined by the administration of:

  1. Transfusions
  2. Filgrastim or Pegfilgrastim
  3. Erythropoietin
  4. Palifermin
During a maximum of six 3-week chemotherapy cycles

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Tarix Pharmaceuticals

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2008

Primær fullføring (Faktiske)

1. desember 2011

Studiet fullført (Faktiske)

1. desember 2011

Datoer for studieregistrering

Først innsendt

9. oktober 2008

Først innsendt som oppfylte QC-kriteriene

9. oktober 2008

Først lagt ut (Anslag)

13. oktober 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. november 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. oktober 2017

Sist bekreftet

1. oktober 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • TXA127-2007-002

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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