- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02312661
Study of Metformin With Carboplatin/Paclitaxel Chemotherapy in Patients With Advanced Ovarian Cancer (OVMET)
6. april 2018 opdateret af: Dr. M. Jalving, University Medical Center Groningen
Phase Ib Study of Metformin in Combination With Carboplatin/Paclitaxel Chemotherapy in Patients With Advanced Ovarian Cancer
Molecularly targeted agents which inhibit the mammalian target of rapamycin (mTOR) pathway and/or circumvent p53 in the induction of apoptosis are exciting potential targets in ovarian cancer.
Metformin is a biguanide, widely used in the treatment of type 2 diabetes mellitus, that has shown anti-cancer activity in preclinical studies.
The main mechanism of metformin's effect is mTOR pathway inhibition and, in addition, it has been shown to circumvent p53-induced apoptosis making it an exciting, potentially effective drug in ovarian cancer.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
A phase Ib, single-centre, dose-escalation trial with a traditional escalation rule with fixed dose levels ("3 + 3" rule).
The recommended phase II dose will be defined as the maximum predefined dose level at which 0 of 3 or ≤ 1 of 6 subjects experience a drug-related dose limiting toxicity (DLT) during cycle 1 and 2 of treatment.
An estimated 10-20 patients will be required for this study.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
15
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Groningen, Holland, 9713 GZ
- University Mecdical Center Groningen
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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:
- Patients with advanced stage (FIGO III-IV), histologically confirmed and documented epithelial ovarian carcinoma
- Patients eligible for neo-adjuvant carboplatin/paclitaxel chemotherapy prior to surgical debulking OR patients with relapsed or progressive ovarian cancer after initial treatment eligible for palliative carboplatin/paclitaxel chemotherapy
- Eastern Cooperative Oncology Group-performance status (ECOG-PS) of 0-2
- Age ≥ 18 years
- Laboratory Requirements - within 7 days prior to enrolment:
- absolute neutrophil count (ANC) ≥1.5 x 109/L
- platelets > 100 x 109/L
- hemoglobin >9g/dl. Patients may be transfused or use erythropoietin to maintain hemoglobin values ≥ 9 g/dl.
- hepatic function: bilirubin ≤1.5×upper limit of normal (ULN), aspartate aminotransferase (AST)/ALT≤2.5×ULN
- estimated creatinine clearance ≥ 60ml/min
- Before patient registration/randomization, written informed consent for the trial must be given according to International Conference on Harmonisation (ICH)/ good clinical practice (GCP), and national/local regulations.
Exclusion Criteria:
- Current or recent (within 30 days of first study dosing) treatment with another investigational drug or participation in another investigational study.
- Metformin within 4 weeks prior to enrolment.
- Symptomatic central nervous system (CNS) metastasis
- Pre-existing peripheral neuropathy ≥ Common toxicity criteria (CTC) grade 2.
- Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start.
- Women of childbearing potential (defined as <2 years after last menstruation and not surgically sterile) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly) during the study and for 6 months after the last study medication.
- Known hypersensitivity to any of the study drugs or excipients.
- Serious active infection requiring i.v. antibiotics at enrolment.
- Unstable medical conditions.
- Evidence of any other medical conditions, physical examination or laboratory findings that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment related complications.
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Carboplatin / paclitaxel /metformin
Three-weekly cycles of carboplatin/paclitaxel chemotherapy in combination with metformin treatment
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Metformin in increasing doses will be added to carboplatin/paclitaxel chemotherapy
Intravenous carboplatin chemotherapy in three-weekly cycles, for a maximum of 6 cycles
Intravenous paclitaxel chemotherapy in three-weekly cycles, for a maximum of 6 cycles
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of participants with Adverse Events as a measure of safety and tolerability
Tidsramme: 1-2 years
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Data will be used to determine recommended phase 2 dose
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1-2 years
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Pharmacokinetics (AUC, Tmax,Cmax) of carboplatin and paclitaxel chemotherapie
Tidsramme: 1-2 years
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1-2 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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 (Faktiske)
5. oktober 2015
Primær færdiggørelse (Faktiske)
1. november 2017
Studieafslutning (Faktiske)
1. november 2017
Datoer for studieregistrering
Først indsendt
28. november 2014
Først indsendt, der opfyldte QC-kriterier
8. december 2014
Først opslået (Skøn)
9. december 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. april 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. april 2018
Sidst verificeret
1. april 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Karcinom
- Neoplasmer, kirtel og epitel
- Genitale neoplasmer, kvindelige
- Sygdomme i det endokrine system
- Ovariesygdomme
- Adnexale sygdomme
- Gonadale lidelser
- Neoplasmer i endokrine kirtler
- Ovariale neoplasmer
- Karcinom, ovarieepitel
- Hypoglykæmiske midler
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, fytogene
- Carboplatin
- Paclitaxel
- Metformin
Andre undersøgelses-id-numre
- 30102012
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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