- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00710762
A Randomised Placebo-Controlled Phase II Study of Continuous Maintenance Treatment With BIBF 1120 Following Chemotherapy in Patients With Relapsed Ovarian Cancer
Przegląd badań
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 2
Kontakty i lokalizacje
Lokalizacje studiów
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Burton on Trent, Zjednoczone Królestwo
- 1199.9.4413 Boehringer Ingelheim Investigational Site
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Cambridge, Zjednoczone Królestwo
- 1199.9.4412 Boehringer Ingelheim Investigational Site
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Creigiau, Cardiff, Zjednoczone Królestwo
- 1199.9.4407 Boehringer Ingelheim Investigational Site
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Leeds, Zjednoczone Królestwo
- 1199.9.4410 St James's University Hospital
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London, Zjednoczone Królestwo
- 1199.9.4401 Boehringer Ingelheim Investigational Site
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London, Zjednoczone Królestwo
- 1199.9.4404 Boehringer Ingelheim Investigational Site
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London, Zjednoczone Królestwo
- 1199.9.4409 Boehringer Ingelheim Investigational Site
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London, Zjednoczone Królestwo
- 1199.9.4411 Boehringer Ingelheim Investigational Site
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Manchester, Zjednoczone Królestwo
- 1199.9.4406 Boehringer Ingelheim Investigational Site
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Northwood, Zjednoczone Królestwo
- 1199.9.4402 Boehringer Ingelheim Investigational Site
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Sutton, Zjednoczone Królestwo
- 1199.9.4405 Boehringer Ingelheim Investigational Site
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Model interwencyjny: Przydział równoległy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Komparator placebo: Placebo
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Eksperymentalny: BIBF1120
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
PFS Rate at 36 Weeks (After 9 Months)
Ramy czasowe: 36 weeks (after 9 months)
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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.
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36 weeks (after 9 months)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
PFS Rate at 12 Weeks (After 3 Months) and 24 Weeks ( After 6 Months)
Ramy czasowe: 12 weeks (after 3 months) and 24 weeks ( after 6 months)
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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.
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12 weeks (after 3 months) and 24 weeks ( after 6 months)
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Time to Tumour Progression
Ramy czasowe: 9 months
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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
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Time to Death
Ramy czasowe: 9 months
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This end point was not determined as no patients died during the trial.
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9 months
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Incidence and Intensity of Adverse Events With Grading According CTCAE
Ramy czasowe: First drug administration until 28 days after last drug administration,up until 309 days
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Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).
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First drug administration until 28 days after last drug administration,up until 309 days
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Clinical Relevant Abnormalities for Laboratory Parameters
Ramy czasowe: First drug administration until 28 days after last drug administration, up until 309 days
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Clinical Relevant Abnormalities for laboratory parameters.
Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events.
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First drug administration until 28 days after last drug administration, up until 309 days
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Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Nowotwory
- Nowotwory układu moczowo-płciowego
- Nowotwory według lokalizacji
- Nowotwory narządów płciowych, kobiety
- Choroby układu hormonalnego
- Choroby jajników
- Choroby przydatków
- Zaburzenia gonad
- Nowotwory gruczołów dokrewnych
- Nowotwory jajnika
- Molekularne mechanizmy działania farmakologicznego
- Inhibitory enzymów
- Środki przeciwnowotworowe
- Inhibitory kinazy białkowej
- Nintedanib
Inne numery identyfikacyjne badania
- 1199.9
- EUDRACT2005-002427-14
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Badania kliniczne na Placebo
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AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyZakończonyMężczyźni z cukrzycą typu II (T2DM)Niemcy
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West Penn Allegheny Health SystemZakończonyAstma | Alergiczny nieżyt nosaStany Zjednoczone
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Heptares Therapeutics LimitedZakończonyFarmakokinetyka | Problemy z bezpieczeństwemZjednoczone Królestwo
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Longeveron Inc.ZakończonyZespół niedorozwoju lewego sercaStany Zjednoczone
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ItalfarmacoZakończonyDystrofia mięśniowa BeckeraHolandia, Włochy
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Soroka University Medical CenterZakończony
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Regado Biosciences, Inc.ZakończonyZdrowy ochotnikStany Zjednoczone