Doxorubicin + BIBF 1120 in Patients for Ovarian Cancer

This is an interventional treatment trial for Ovarian Cancer focused on measuring BIBF 1120 Read More

Inclusion Criteria:

• Platinum-resistant (recurrence within 6 months of a platinum-containing regimen) or platinum refractory (progression while on platinum) disease.
• Measurable disease as defined by RECIST v1.1 criteria on screening testing
• Be ≥18 years of age at the time of providing written informed consent for participation.
• Give written, informed consent for participation in the protocol.
• Must consent to correlative blood sample collections.
• Be at least 4 weeks from last treatment to allow recovery from prior toxicity to a Grade 1 or less.
• The following exceptions are allowed: hormonal therapy - 1 week wash-out; radiation therapy - 3 week wash-out; weekly chemotherapy - 3 week wash-out
• Patients coming off experimental therapy with biological agents with long half lives (e.g., antibodies) not expected to cause myelotoxicity should be off treatment for at least 4 weeks.
• Negative serum pregnancy test within 14 days prior to the study entry and be practicing an effective form of contraception if hysterectomy and/or oophorectomy was not part of the prior treatment

Exclusion Criteria:

• Prior therapy with pegylated liposomal doxorubicin or doxorubicin.
• Prior therapy with BIBF 1120.
• Prior anti-angiogenic therapy with tyrosine kinase inhibitors (e.g. sorafenib, sunitinib, others). Note: Prior therapy with bevacizumab is allowed, provided that at least 3 months have elapsed since the last dose of bevacizumab.
• Grade 2 or greater neuropathy, at time of registration.
• Active cancer within the last 5 years, with the exception of superficial skin cancer (basal cell or squamous cell skin carcinoma), carcinoma in situ of the cervix, Stage I endometrial cancer with less than 50% invasion of the myometrium, or other adequately treated Stage I or II cancer in complete remission.
• Presence of active infection requiring antibiotic treatment, at time of registration.
• Presence of uncontrolled serious medical condition or psychiatric illness as determined by the treating physician, at time of registration.
• Known history of immune deficiency and be receiving combination anti-retroviral therapy
• Known or clinically manifest brain metastases, as progressive neurologic dysfunction may develop, that would confound the evaluation of neurologic and other adverse events.
• Presence of gastrointestinal disorders or abnormalities that would influence the absorption of the study drug.
• Presence of uncontrolled hypertension, arrhythmia, congestive heart failure or angina, at time of registration. Patients who have had a myocardial infarction or cardiac surgery should be at least 6 months from the event and free of active symptoms.
• Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infection disease or laboratory abnormality that may increase the risk associated with study participation or study drug administration.
• Major injuries within the past 4 weeks prior to start of study treatment with incomplete wound healing and/or planned surgery during the on-treatment study period.
• History of clinically significant hemorrhagic or thromboembolic event in the past 6 months