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A Randomised Placebo-Controlled Phase II Study of Continuous Maintenance Treatment With BIBF 1120 Following Chemotherapy in Patients With Relapsed Ovarian Cancer

13. juli 2016 oppdatert av: Boehringer Ingelheim
The primary objective of this study is to estimate the Progression Free Survival Rates (PFS) of patients with relapsed ovarian cancer after 9 months of continuous treatment with either BIBF 1120 or matching placebo.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

89

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

  • Storbritannia
      • Burton on Trent, Storbritannia
        • 1199.9.4413 Boehringer Ingelheim Investigational Site
      • Cambridge, Storbritannia
        • 1199.9.4412 Boehringer Ingelheim Investigational Site
      • Creigiau, Cardiff, Storbritannia
        • 1199.9.4407 Boehringer Ingelheim Investigational Site
      • Leeds, Storbritannia
        • 1199.9.4410 St James's University Hospital
      • London, Storbritannia
        • 1199.9.4401 Boehringer Ingelheim Investigational Site
      • London, Storbritannia
        • 1199.9.4404 Boehringer Ingelheim Investigational Site
      • London, Storbritannia
        • 1199.9.4409 Boehringer Ingelheim Investigational Site
      • London, Storbritannia
        • 1199.9.4411 Boehringer Ingelheim Investigational Site
      • Manchester, Storbritannia
        • 1199.9.4406 Boehringer Ingelheim Investigational Site
      • Northwood, Storbritannia
        • 1199.9.4402 Boehringer Ingelheim Investigational Site
      • Sutton, Storbritannia
        • 1199.9.4405 Boehringer Ingelheim Investigational Site

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:

  • Female patients with histologically confirmed advanced ovarian carcinoma, fallopian tube carcinoma or primary peritoneal cancer of serous type with recurrent disease and who responded to 2nd, 3rd or 4th line chemotherapy. Response is defined as either a confirmed decline in CA125 of at least 50% from the pre-treatment value or an Objective Response, i.e. a Partial Response (PR) or Complete Response (CR) according to the RECIST criteria in patients with measurable disease.
  • Treatment-free interval of < 12 months since commencing prior treatment regimen for relapsed ovarian cancer.
  • Full recovery from all therapy related toxicities of previous chemotherapy and or radiotherapy or recovery in as much as no further improvement may be expected by the investigator.
  • Age > 18 years.
  • Life expectancy of at least 3 months.
  • ECOG Performance Score < 2.
  • Adequate hepatic function: total bilirubin 26µmol/L, ALT and/or AST 1.5x upper limit of normal (ULN). INR, Prothrombin time (PT) and partial thromboplastin time (PTT): maximum 50% deviation from normal limits.
  • Adequate renal function: serum creatinine 1.5 x ULN.
  • Absolute neutrophil count (ANC) >1.5 x 109l, Platelets > 100 x 109/l, Haemoglobin > 9.0 g/dl.
  • Written informed consent consistent with ICH-GCP guidelines.
  • Minimum time elapsed since last chemotherapy (including hormonal treatment other than Hormone Replacement Therapy [HRT]) or immunotherapy and the first administration of BIBF 1120 must be more than 4 but less than 8 weeks.

Exclusion Criteria:

  • Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study.
  • Major injuries and/or surgery within past 4 weeks with incomplete wound healing or bone fracture and planned surgical procedures during the study period.
  • Hypersensitivity to BIBF 1120 or the excipients of the study drug.
  • Significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction within past 9 months, congestive heart failure > NYHA II).
  • History of haemorrhagic or thrombotic event in the past 12 months. Known inherited predisposition to bleeds or to thrombosis.
  • Patients who require full-dose anticoagulation.
  • Gastrointestinal disorders or abnormalities that would inhibit absorption of the study drug.
  • Brain metastases or leptomeningeal disease.
  • Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial.
  • Chemo-, radio-, or immunotherapy within the past four weeks prior to treatment with the trial drug.
  • Patients unable to comply with the protocol.
  • Active alcohol or drug abuse.
  • Other documented malignancy with the exception of non-melanomatous skin cancer within the past 5 years.
  • Patients who are not clinically sterile.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Intervensjonsmodell: Parallell tildeling

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Legemiddel: Placebo
Eksperimentell: BIBF1120
Legemiddel: BIBF1120

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
PFS Rate at 36 Weeks (After 9 Months)
Tidsramme: 36 weeks (after 9 months)
The rate (probability) of being progression free at Week 36. Progression Free Survival (PFS) was defined according to RECIST version 1.0 from the time of first study drug administration to the first time of either objective tumour progression, the appearance of ≥1 new tumour lesion(s), occurrence or significant progression of malignant ascites, tumour related death, or the time when patients were censored at last known follow up. The rate is the Kaplan-Meier estimated percent probability.
36 weeks (after 9 months)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
PFS Rate at 12 Weeks (After 3 Months) and 24 Weeks ( After 6 Months)
Tidsramme: 12 weeks (after 3 months) and 24 weeks ( after 6 months)
The rate (probability) of being progression free at Week 12 and Week 24. Progression Free Survival (PFS) was defined according to RECIST version 1.0 from the time of first study drug administration to the first time of either objective tumour progression, the appearance of ≥1 new tumour lesion(s), occurrence or significant progression of malignant ascites, tumour related death, or the time when patients were censored at last known follow up. The rate is the Kaplan-Meier estimated percent probability.
12 weeks (after 3 months) and 24 weeks ( after 6 months)
Time to Tumour Progression
Tidsramme: 9 months

Time to Tumour Progression according to RECIST version 1.0 , CA-125 (ovarian tumour marker) levels and RECIST + CA-125 levels.

For CA-125, progressive disease was defined on the basis of progressive serial elevations of CA-125 according to the following criteria:

Patients with elevated CA-125 pre-treatment and normalisation of CA-125 had to show evidence of CA-125 levels ≥2 x ULN on 2 occasions at least 1 week apart. or Patients with elevated CA-125 pre-treatment that never normalised had to show evidence of CA-125 levels ≥2 x the nadir value on 2 occasions at least 1 week apart. or Patients with CA-125 in the normal range pre-treatment had to show evidence of CA-125 levels ≥2 x ULN on 2 occasions at least 1 week apart.

Composite (RECIST+CA-125) endpoint is the RECIST progressive disease (PD) if it occurred or the CA-125 PD if it occurred in the absence of RECIST PD.
9 months
Time to Death
Tidsramme: 9 months
This end point was not determined as no patients died during the trial.
9 months
Incidence and Intensity of Adverse Events With Grading According CTCAE
Tidsramme: First drug administration until 28 days after last drug administration,up until 309 days
Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).
First drug administration until 28 days after last drug administration,up until 309 days
Clinical Relevant Abnormalities for Laboratory Parameters
Tidsramme: First drug administration until 28 days after last drug administration, up until 309 days
Clinical Relevant Abnormalities for laboratory parameters. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events.
First drug administration until 28 days after last drug administration, up until 309 days

Samarbeidspartnere og etterforskere

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

Sponsor

Boehringer Ingelheim

Publikasjoner og nyttige lenker

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Hjelpsomme linker

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. mars 2006

Primær fullføring (Faktiske)

1. september 2008

Studiet fullført (Faktiske)

1. mars 2014

Datoer for studieregistrering

Først innsendt

3. juli 2008

Først innsendt som oppfylte QC-kriteriene

3. juli 2008

Først lagt ut (Anslag)

4. juli 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

15. august 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. juli 2016

Sist bekreftet

1. juli 2016

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 1199.9
  • EUDRACT2005-002427-14

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