FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has waived the obligation to submit the results of studies with Rubraca in all subsets of the paediatric population in ovarian cancer (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Rubraca for alle undergrupper af den pædiatriske population for kræft i æggestokkene (se pkt.
English: Increased rucaparib-induced cytotoxicity and anti-tumour activity was observed in tumour cell lines with deficiencies in BRCA1/2 and other DNA repair genes.
Danish: Der er observeret øget rucaparib-induceret cytotoksicitet og antitumoraktivitet i tumorcellelinjer med defekter i BRCA1/2 og andre DNA-reparationsgener.
English: • Rubraca is available as either 200 mg, 250 mg or 300 mg tablets.
Danish: - Rubraca fås som enten 200 mg, 250 mg eller 300 mg tabletter.
English: For risk mitigation and management, see section 4.4.
Danish: Oplysninger om risikoreduktion og -håndtering, se pkt.
English: Adverse reactions leading to permanent discontinuation occurred in 10% of patients, with thrombocytopenia, nausea, anaemia, and fatigue/asthenia being the most frequent adverse reactions leading to permanent discontinuation.
Danish: Bivirkninger, der førte til permanent ophør, skete for 10 % af patienterne, hvor trombocytopeni, kvalme, anæmi og træthed/asteni var de hyppigste bivirkninger, der førte til permanent seponering
English: Rubraca can also be used if your cancer has progressed after chemotherapy has been used and you have an abnormality of the BRCA gene.
Danish: Rubraca kan også anvendes, hvis din kræft har udviklet sig efter, at der er anvendt kemoterapi, og hvis du har et unormalt BRCA-gen.
English: Events related to increases in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were observed in 38% (all grades) and 11% (≥ CTCAE Grade 3) of patients.
Danish: Stigninger i serum-aminotransferaser (ASAT/ALAT) Bivirkninger relateret til stigninger i alanin-aminotransferase (ALAT) og aspartat-aminotransferase (ASAT), blev observeret hos 38 % (alle klasser) og 11 % (≥ CTCAE Klasse 3) af patienterne.
English: Patients included in the population PK study were aged 21 to 86 years (58% < 65 years, 31% 65-74 years, and 11% > 75 years), 82% were Caucasian, and had body weights between 41 and 171 kg (73% had body weight > 60 kg).
Danish: Patienter, der er inkluderet i populations-PK-forsøget var 21til 86 år (58 % < 65 år, 31 % 65 74 år og 11 % > 75 år), 82 % var kaukasiere og havde kropsvægt på mellem 41 og 171 kg (73 % havde kropsvægt > 60 kg).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE FLASKEETIKET
English: No cardiac effects were observed with oral dosing of rucaparib in repeat-dose toxicology studies at a rucaparib Cmax comparable to that observed in patients.
Danish: Ingen hjertepåvirkninger blev observeret med oral dosering af rucaparib i toksikologiske studier med gentagne doser af rucaparib Cmax sammenlignet med dem, som blev set hos patienter.
English: Recommended dose adjustments Dose reduction
Danish: Anbefalede dosisjusteringer Dosisreduktion
English: In a population PK analysis, no clinically relevant PK differences were observed among patients with different CYP2D6 phenotypes (including poor metabolizers, n=9; intermediate metabolizers, n=71; normal metabolizers, n=76; and ultra-rapid metabolizers, n=4) or patients with different CYP1A2 phenotypes (including normal metabolizers, n=28; hyperinducers, n=136).
Danish: I en populations PK-analyse blev der ikke set klinisk relevante PK forskelle blandt patienter med forskellige CYP2D6-fænotyper (herunder dårlige metabolisatorer, n=9; intermediær metabolisatorer, n=71; normale metabolisatorer, n=76; og ultrahurtige metabolisatorer, n=4) eller patienter med forskellige CYP1A2-fænotyper (herunder normale metabolisatorer, n=28; hyperinducere, n=136).
English: Pregnancy/contraception
Danish: Graviditet/prævention
English: Patients could not have received prior rucaparib or other PARP inhibitor therapy.
Danish: Patienterne måtte ikke tidligere have fået rucaparib eller anden PARP-hæmmerbehandling.
English: Grade 4
Danish: Klasse 4
English: Patients should be advised to use effective contraception during treatment and for 6 months following the last dose of rucaparib.
Danish: Patienter skal instrueres i at bruge effektiv prævention under behandling og i 6 måneder efter den sidste dosis rucaparib.
English: The median progression-free survival was 162 days (95% CI [51-223]).
Danish: Den gennemsnitlige progressionsfri overlevelse var 162 dage (95 % CI [51-223]).
English: Management of Treatment-emergent AST/ ALT Elevations Grade of AST/ALT Elevation
Danish: Håndtering af behandlingsrelaterede ASAT/ALAT-forhøjelser Klassificering af ASAT/ALAT-forhøjelse
English: In patients with cancer following a high-fat meal, the Cmax increased by 20%, the AUC0-24h increased by 38%, and the Tmax was delayed by 2.5 hours, as compared with dosing under fasted conditions.
Danish: Hos patienter med kræft steg Cmax efter et fedtrigt måltid med 20 %, AUC0-24 t steg med 38 %, og Tmax blev forsinket 2,5 timer, sammenlignet med dosering under fastende forhold.
English: Summary of primary efficacy findings for patients with BRCA-mutant ovarian cancer who received rucaparib 600 mg twice daily and two or more prior chemotherapy regimens based on investigator assessment of response
Danish: Oversigt over primære fund for virkning for patienter med BRCA-muteret kræft i æggestokkene, som har modtaget rucaparib 600 mg to gange dagligt og to eller flere tidligere kemoterapibehandlinger baseret på investigators responsvurdering
English: No clinically important differences were observed between 34 patients with mild hepatic impairment (total bilirubin ≤ ULN and AST > ULN or total bilirubin > 1.0 to 1.5 times ULN and any AST) and 337 patients with normal hepatic function.
Danish: Ingen klinisk vigtige forskelle blev observeret mellem 34 patienter med let nedsat leverfunktion (total bilirubin ≤ ULN og ASAT > ULN eller total bilirubin > 1,0 til 1,5 gange ULN og eventuelle ASAT) og 337 personer med normal leverfunktion.
English: Most patients could continue rucaparib with or without treatment modification without recurrence of
Danish: De fleste patienter kunne fortsætte med rucaparib med eller uden behandlingsændring uden recidiv af klasse ≥ 3 LFTabnormiteter.
English: For the maintenance treatment, patients should start the maintenance treatment with Rubraca no later than 8 weeks after completion of their final dose of the platinum containing regimen.
Danish: Ved vedligeholdelsesbehandling skal patienten påbegynde vedligeholdelsesbehandling med Rubraca senest 8 uger efter at have taget sidste dosis af den platinholdige behandling.
English: No dose adjustment is considered necessary for co-administered medicinal products that are CYP2C19 substrates.
Danish: Dosisjustering anses ikke for at være nødvendig for samtidige lægemidler, som er CYP2C19-substrater.
English: Caution when driving or using machines is advised for patients who report fatigue, nausea, or dizziness during treatment with Rubraca (see section 4.8).
Danish: Forsigtighed tilrådes ved bilkørsel eller betjening af maskiner for patienter, der rapporterer træthed, kvalme eller svimmelhed under behandling med Rubraca (se pkt.
English: HR (95% CI) p-valueb
Danish: HR (95 % CI) p-værdib
English: Prior bevacizumab therapy was reported for 22% of patients who received rucaparib and 23% of patients who received placebo.
Danish: Tidligere bevacizumabbehandling blev rapporteret hos 22 % af de patienter, der fik rucaparib og 23 % af de patienter, der fik placebo.
English: 282 days (95% CI [218-335]), and the median overall survival was 18.8 months (95% CI [12.9-NA]).
Danish: Den gennemsnitlige progressionsfri overlevelse var 282 dage (95 % CI [218-335]), og den gennemsnitlige generelle overlevelse var 18,8 måneder (95% CI [12,9 -NA]).
English: or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy.
Danish: tubacancer eller primær peritonealcancer, som er blevet behandlet med to eller flere tidligere linjer af platinbaseret kemoterapi og som ikke kan tolerere platinbaseret kemoterapi.
English: • The usual recommended dose is 600 mg twice a day.
Danish: - Den sædvanlige anbefalede dosis er 600 mg to gange dagligt.
English: Embryofetal toxicity
Danish: Embryoføtal toksicitet
English: Fatiguec, Pyrexia
Danish: Træthed c, pyreksi
English: Based on the animal studies, impact on fertility associated with the use of rucaparib cannot be ruled out (see section 5.3).
Danish: Baseret på dyreforsøgene kan det ikke udelukkes, at brug af rucaparib kan påvirke fertilitet (se pkt.
English: b. Two-sided p-value c. HRD includes all patients with a deleterious germline or somatic BRCA mutation or non-tBRCA with high genomic loss of heterozygosity, as determined by the clinical trial assay (CTA).
Danish: b. To-sidet p-værdi c. HRD omfatter alle patienter med en skadelig kimcellelinje eller somatisk BRCA-mutation eller non tBRCA med højt genomisk tab af heterozygositet, som fastsat af Clinical Trial Assay (CTA).
English: Caution is recommended when rucaparib is co-administered with medicinal products that are strong inhibitors of P-gp.
Danish: Der anbefales forsigtighed, når rucaparib administreres samtidig med lægemidler, som er stærke hæmmere af P-gp.
English: In a medicinal product interaction study in cancer patients, the effects of steady-state rucaparib at 600 mg twice daily on CYP1A2, CYP2C9, CYP2C19, CYP3A, and P-gp were evaluated with single oral doses of sensitive probes (caffeine, S-warfarin, omeprazole, midazolam, and digoxin, respectively).
Danish: I et lægemiddel-interaktionsforsøg med kræftpatienter blev virkningerne af steady-state rucaparib på 600 mg to gange dagligt på CYP1A2, CYP2C9, CYP2C19, CYP3A og P-gp evalueret med orale enkeltdoser af følsomme prober (henholdsvis koffein, S-warfarin, omeprazol, midazolam og digoxin).
English: Microcrystalline cellulose Sodium starch glycolate (Type A) Colloidal anhydrous silica Magnesium stearate
Danish: Mikrokrystallinsk cellulose Natriumstivelsesglycolat (type A) Kolloid vandfri silica Magnesiumstearat
English: Following administration of a single oral dose of [14C]-rucaparib 600 mg to patients, the overall mean recovery of radioactivity was 89.3%, with a mean recovery of 71.9% in faeces and 17.4% in urine by 288 hours post dose.
Danish: Efter administration af en enkelt oral dosis [14C]-rucaparib på 600 mg til patienter lå den samlede gennemsnitlige udskillelse af radioaktivitet på 89,3 %, med en gennemsnitlig udskillelse på 71,9 % i fæces og 17,4 % i urin 288 timer efter dosis.
English: ORR was similar for patients with germline BRCA-mutant ovarian cancer or somatic BRCA-mutant ovarian cancer and for patients with a BRCA1 gene mutation or BRCA2 gene mutation.
Danish: ORR var ens for patienter med kimcelle BRCA-muteret kræft i æggestokkene eller somatisk BRCA-muteret kræft i æggestokkene og for patienter med en BRCA1 genmutation eller BRCA2 genmutation.
English: • If you are sick (vomit) after taking Rubraca, do not take an extra dose.
Danish: - Hvis du kaster op efter, at du har taget Rubraca, må du ikke tage en ekstra dosis.
English: • If you forget to take a dose, skip the missed dose.
Danish: - Hvis du har glemt at tage en dosis, skal du springe den glemte dosis over.
English: Increased ALT was observed in 34.8% (all grades) and 9.9% (≥ CTCAE Grade 3) of patients, increased AST in 31.4% (all grades) and 2.8% (≥ CTCAE Grade 3) of patients and increased ALT and AST in 28.6% (all grades) and 2.1% (≥ CTCAE Grade 3) of patients.
Danish: Der blev observeret øget ALAT hos 34,8 % (alle klasser) og 9,9 % (≥ CTCAE klasse 3) af patienterne, øget ASAT hos 31,4 % (alle klasser) og 2,8 % (≥ CTCAE klasse 3) af patienter og øget ALAT og ASAT hos 28,6 % (alle klasser) og 2,1 % (≥ CTCAE klasse 3) af patienterne.
English: In patients ≥ 75 years old, frequencies of some adverse reactions increased: increased blood creatinine (32%), dizziness (20%), pruritus (15%), and memory impairment (4%) were higher than in patients < 75 years old (18%, 15%, 9% and 1% respectively).
Danish: Hos patienter ≥ 75 år steg hyppigheden af nogle bivirkninger: øget blodkreatinin (32 %), svimmelhed (20 %), pruritus (15 %) og hukommelsessvækkelse (4 %) var højere end hos patienter < 75 år (hhv. 18 %, 15 %, 9 % og 1 %).
English: There are no animal studies on the excretion of rucaparib in breast milk.
Danish: Der er ingen dyreforsøg med udskillelse af rucaparib i modermælk.
English: Leukopeniab, Lymphopeniab, Febrile neutropenia
Danish: Leukopenib, lymfopenib, febril neutropeni
English: At clinical exposures, rucaparib did not inhibit bile salt export pump (BSEP), OATP1B1, OATP1B3, OAT1 and OAT3.
Danish: Ved kliniske eksponeringer hæmmede rucaparib ikke eksportpumpning af galdesalt (BSEP), OATP1B1, OATP1B3, OAT1 og OAT3.
English: In vitro, rucaparib was shown to be a substrate of P-gp and BCRP, but not a substrate of renal uptake transporters OAT1, OAT3, and OCT2, or hepatic transporters OAPT1B1 and OATP1B3.
Danish: In vitro blev rucaparib påvist at være et substrat for P-gp og BCRP, men ikke et substrat for nyreoptagelsestransportører OAT1, OAT3 og OCT2, eller hepatiske transportere OAPT1B1 og OATP1B3.
English: d. tBRCA includes all patients with a deleterious germline or somatic BRCA mutation, as determined by the CTA.
Danish: d. tBRCA omfatter alle patienter med en skadelig kimcellelinje eller somatisk BRCA-mutation, som fastsat af CTA.
English: Rubraca must not be used during breast-feeding.
Danish: Rubraca må ikke anvendes under amning.
English: There are limited clinical data in patients with moderate or severe hepatic impairment (ie, any total bilirubin greater than 1.5 times ULN), therefore rucaparib is not recommended for use in patients with moderate or severe hepatic impairment.
Danish: Der er begrænsede kliniske data for patienter med moderat eller svært nedsat leverfunktion (dvs. enhver total bilirubin større end 1,5 gange ULN), hvorfor rucaparib ikke anbefales til brug hos patienter med moderat eller alvorligt nedsat leverfunktion.
English: At the predicted median steady-state Cmax following 600 mg rucaparib twice daily, the projected QTcF increase from baseline was 11.5 msec (90% CI: 8.77 to 14.2 msec).
Danish: Ved den forventede gennemsnitlige steady-state Cmax efter 600 mg rucaparib to gange dagligt var den projekterede QTcF-forlængelse i forhold til baseline 11,5 msek (90 % konfidensinterval: 8,77 til 14,2 msek).
English: No studies have been conducted to investigate the pharmacokinetics of rucaparib in paediatric patients.
Danish: Ingen studier er blevet udført til undersøgelse af farmakokinetikken af rucaparib hos pædiatriske patienter.
English: No dose adjustment is recommended for co-administered medicinal products that are P-gp substrates.
Danish: Der anbefales ingen dosisjustering af samtidige lægemidler, som er Pgp-substrater.
English: In the tBRCA population, 31% of patients (40/130) in the rucaparib group and 35% of patients (23/66) in the placebo group had measurable disease at baseline.
Danish: I tBRCA-populationen havde 31 % af patienterne (40/130) i rucaparibgruppen og 35 % af patienterne (23/66) i placebogruppen målbar sygdom ved baseline.
English: When co-administering medicinal products metabolized by CYP1A2, particularly medicines which have a narrow therapeutic index (e.g., tizanidine, theophylline), dose adjustments may be considered based on appropriate clinical monitoring.
Danish: Ved samtidig indgivelse af lægemidler metaboliseret af CYP1A2, især anden medicin med et snævert terapeutisk indeks (f.eks. tizanidin, theophyllin), kan dosisjusteringer overvejes baseret på en passende klinisk monitorering.
English: • Do not breast-feed during treatment with Rubraca, and for two weeks after taking the last dose.
Danish: - Du må ikke amme under behandling med Rubraca, og i to uger efter indtagelse af sidste dosis.
English: Rucaparib also marginally inhibits P-gp in the gut.
Danish: Rucaparib hæmmer også marginalt P-gp i tarmen.
English: If, following investigation for prolonged haematological toxicity, MDS/AML is confirmed, Rubraca should be discontinued.
Danish: Hvis MDS/AML bekræftes efter undersøgelse for længerevarende hæmatologiske toksicitet, skal Rubraca seponeres.
English: Missed doses If a dose is missed, the patient should resume taking Rubraca with the next scheduled dose.
Danish: Hvis en dosis glemmes, skal patienten tage Rubraca igen ved næste planlagte dosis.
English: Increased transaminasesb
Danish: Øgede transaminaserb
English: Rucaparib showed no effect on Cmax of caffeine while moderately increasing AUCinf of caffeine by 2.55 fold (90% CI: 2.12, 3.08).
Danish: Rucaparib havde ingen virkning på Cmax af koffein, men øgede moderat AUCinf af koffein med 2,55 gange (90 % CI: 2,12, 3,08).
English: If you are not sure, talk to your doctor, pharmacist or nurse before taking Rubraca.
Danish: Er du i tvivl, så spørg lægen, apotekspersonalet eller sundhedspersonalet, før du tager Rubraca.
English: Adverse reactions CTCAE Grade 3 or higher occurred in 23% (anaemia), 8% (neutropenia) and 6% (thrombocytopenia) of patients.
Danish: Bivirkninger CTCAE klasse 3 eller højere forekom hos 23 % (anæmi), 8 % (neutropeni) og 6 % (trombocytopeni) af patienterne.
English: In an exploratory analysis in this subgroup, a response was noted in 18% (95% CI 12% - 26%) of patients (n=26) on rucaparib compared to 8% (95% CI 3% - 17%) of patients (n=5) on placebo (2-sided p-value = 0.0069), including 10 patients (7%) in the rucaparib group who achieved a complete remission.
Danish: I en eksplorativ analyse i denne undergruppe blev der noteret respons hos 18 % (95 % CI 12 % - 26 %) af patienterne (n=26) på rucaparib sammenlignet med 8 % (95 % CI 3 % - 17 %) af patienterne (n=5) på placebo (to-sidet p-værdi = 0,0069), herunder 10 patienter (7 %) i rucaparibgruppen, der opnåede en komplet remission.
English: A pregnancy test before initiating treatment is recommended in women of reproductive potential.
Danish: Det anbefales at foretage en graviditetstest hos kvinder i den fødedygtige alder før behandlingspåbegyndelse.
English: Women of childbearing potential/contraception in females
Danish: Fertile kvinder/prævention til kvinder
English: Women of reproductive potential should be advised to use effective contraception during treatment and for 6 months following the last dose of Rubraca (see section 4.6).
Danish: Fødedygtige kvinder skal anbefales at bruge effektiv prævention under behandling og i 6 måneder efter den sidste dosis Rubraca (se pkt.
English: In patients with cancer following rucaparib 600 mg taken twice daily, the mean steady-state Cmax was 1940 ng/mL and AUC0-12h was 16900 h⋅ng/mL with Tmax of 1.9 hours.
Danish: Hos patienter med kræft var den gennemsnitlige steady state, efter rucaparib 600 mg to gange dagligt, Cmax 1940 ng/ml, og AUC0-12 t var 16900 t⋅ng/ml med Tmax på 1,9 timer.
English: Fertility studies have not been conducted with rucaparib.
Danish: Der er ikke udført fertilitetsforsøg med rucaparib.
English: No adjustment is recommended to the starting dose for elderly patients (≥ 65 years of age) (see sections 4.8 and 5.2).
Danish: Ingen justering anbefales af startdosis for ældre patienter (≥ 65 år) (se pkt.
English: When co-administering medicinal products that are CYP2C9 substrates with a narrow therapeutic index (e.g., warfarin, phenytoin), dose adjustments may be considered, if clinically indicated.
Danish: Ved samtidig indgivelse af lægemidler, som er CYP2C9substrater med et snævert terapeutisk indeks (f.eks. warfarin, phenytoin), kan dosisjusteringer overvejes, hvis klinisk indiceret.
English: In the ITT population, 38% of patients (141/375) in the rucaparib group and 35% of patients (66/189) in the placebo group had measurable disease at baseline.
Danish: I ITT-populationen havde 38 % af patienterne (141/375) i rucaparibgruppen og 35 % af patienterne (66/189) i placebogruppen målbar sygdom ved baseline.
English: Treatment of BRCA-mutated ovarian cancer after 2 or more chemotherapies The efficacy of rucaparib was investigated in 106 patients in 2 multicentre, single-arm, open-label clinical studies, Study 10 and ARIEL2, in patients with advanced BRCA-mutant epithelial ovarian, fallopian tube or primary peritoneal cancer who had progressed after 2 or more prior chemotherapies (the primary efficacy population).
Danish: Behandling af BRCA-muteret ovariecancer efter to eller flere kemoterapiforløb Effekten af rucaparib blev undersøgt hos 106 patienter i 2 multicenter, enkelt-arms, ikke-blindede kliniske forsøg, forsøg 10 og ARIEL2, hos patienter med fremskreden BRCA-muteret epitelial kræft i æggestokkene, æggelederne eller primær peritoneal kræft, som var progredieret efter 2 eller flere tidligere kemoterapier (primær effektpopulation).
English: In an exploratory analysis, a response was noted in 38% (95% CI 23% - 54%) of patients (n=15) on rucaparib compared to 9% (95% CI 1%28%) of patients (n=2) on placebo (2-sided p-value = 0.0055), including 7 (18%) patients in the rucaparib group who achieved a complete remission.
Danish: I en eksplorativ analyse blev der noteret respons hos 38 % (95 % CI 23 % - 54 %) af patienterne (n=15) på rucaparib sammenlignet med 9 % (95 % CI 1 % - 28 %) af patienterne (n=2) på placebo (to-sidet p-vædi = 0,0055), herunder 7 (18 %) patienter i rucaparibgruppen, som opnåede en komplet remission.
English: Third dose reduction
Danish: Tredje dosisreduktion
English: Limited data are available for patients with moderate or severe hepatic impairment (see section 4.2).
Danish: Begrænsede data er tilgængelige for patienter med moderat eller svært nedsat leverfunktion (se pkt.
English: Rucaparib down regulated CYP2B6 in human hepatocytes at clinically relevant exposures.
Danish: Rucaparib nedregulerer CYP2B6 i humane hepatocytter ved klinisk relevant eksponering.
English: In vitro, rucaparib is an inhibitor of the BCRP and P-gp efflux transporters.
Danish: In vitro er rucaparib en hæmmer af BCRP og P-gpefflukstransportører.
English: Adverse reactions that most commonly led to dose reduction or interruption were anaemia (20%), fatigue/asthenia (18%), nausea (16%), thrombocytopenia (15%), and AST/ALT elevations (10%).
Danish: Bivirkninger, som hyppigst førte til dosisnedsættelse eller -afbrydelse, var anæmi (20 %), træthed/asteni (18 %), kvalme (16 %), trombocytopeni (15 %) og forhøjet ASAT/ALAT (10 %).
English: Based on in vitro data, CYP2D6, and to a lesser extent CYP1A2 and CYP3A4, were able to metabolize rucaparib.
Danish: Baseret på in vitro data var CYP2D6, og i mindre grad CYP1A2 og CYP3A4, i stand til at metabolisere rucaparib.
English: The efficacy of rucaparib was investigated in ARIEL3, a double-blind, multicentre clinical trial in which 564 patients with recurrent EOC, FTC or PPC who were in response to platinum-based chemotherapy were randomized (2:1) to receive Rubraca tablets 600 mg orally twice daily (n=375) or placebo (n=189).
Danish: Vedligeholdelsesbehandling af recidiverende ovariecancer Effekten af rucaparib blev undersøgt i ARIEL3, et dobbeltblindet klinisk multicenterforsøg, hvor 564 patienter med recidiverende epitelial ovariecancer, tubacancer eller primær peritonealcancer, som responderede på platinbaseret kemoterapi, blev randomiserede (2:1) til Rubracatabletter 600 mg oralt to gange dagligt (n=375) eller placebo (n=189).