BIBF 1120 + Carboplatin/Pegylated Liposomal Doxorubicin (PLD) in Patients With Advanced Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Cancer

Inclusion criteria

• Female patients, age 18 years or older, with a first, second or third relapse of histologically (on initial diagnosis) confirmed epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer
• Up to three lines of prior chemo (chemotherapy before and after interval surgery to be counted as one line therapy), with treatment free interval of > 6 months (= time between last administration of prior anti-cancer treatment, including chemotherapy, hormonal therapy, or radiation therapy, and diagnosis of progressive disease)
• Platinum based chemo in immediately preceding line
• Eligibility for treatment with i.v. chemotherapy regimen of carboplatin AUC 5 and PLD 30 mg/m2 every 4 weeks
• Life expectancy of at least 3 months
• Written informed consent that is consistent with International Conference of Harmonisation (ICH)-Good Clinical Practice (GCP) guidelines
• Eastern Cooperative Oncology Group (ECOG) performance score 0 or1
• Prior treatment with angiogenesis inhibitor (bevacizumab, TKI inhibiting VEGFR-2) is allowed provided treatment with bevacizumab has been discontinued = 28 days prior to start of therapy and treatment with the TKI has been discontinued = 3 months prior to start of therapy, provided anti-angiogenic therapy was added to only one of the preceding lines of therapy

Exclusion criteria

• Prior chemotherapy with doxorubicin (any formulation, liposomal or non-liposomal doxorubicin).
• Any contraindications for therapy with PLD or carboplatin, e.g. a history of hypersensitivity reactions to platinum-containing compounds and their excipients.
• Hypersensitivity to active substance or to any of the excipients of BIBF 1120.
• Treatment with other investigational drugs or participation in another clinical trial testing a drug within the past four weeks before start of therapy or concomitantly with this trial (exception: for previous treatment with angiogenesis inhibitors, cf. inclusion criterion #8).
• Laboratory values indicating an increased risk for adverse events.
• Major surgery within 4 weeks prior to start of study treatment.
• Patients for whom surgery is planned, e.g. interval debulking surgery.
• Clinically relevant non-healing wound, ulcer (intestinal tract, skin) or bone fracture.
• Clinical symptoms or signs of gastrointestinal obstruction that require parenteral nutrition or hydration.
• Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug.
• History of clinical symptoms of brain metastases.
• Prior thrombosis or thromboembolic event in the presence of an inherited coagulopathy.
• History of a cerebral vascular accident, transient ischemic attack or subarachnoid haemorrhage within the past 6 months.
• Known inherited or acquired bleeding disorder.
• Significant cardiovascular diseases.
• Serious infections in particular if requiring systemic antibiotic (antimicrobial, antifungal) or antiviral therapy.
• Other malignancy diagnosed within the past 5 years.
• Known serious illness or concomitant non-oncological disease.
• Patients unable to comply with the protocol.
• Patients with preserved reproductive capacity who are sexually active and unwilling to use a medically acceptable method of contraception.
• Pregnancy or breast feeding.