Dose Escalation Study of BIBF 1120 in Patients With Advanced Gynaecological Malignancies

Launched by BOEHRINGER INGELHEIM · Jul 2, 2014

Keywords

ClinConnect Summary

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Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Female patients with the following histologically confirmed advanced gynaecological malignancies: epithelial ovarian cancer, endometrial carcinoma, uterine sarcoma, mixed Müllerian tumour, fallopian tube carcinoma, primary peritoneal carcinoma, cervical carcinoma or vulvular carcinoma
• • Metastatic disease or locally advanced disease that is not resectable with curative intention
• • Indication for combination chemotherapy with paclitaxel/carboplatin as judged by the investigator
• • Age 18 years or older
• • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• • Life expectancy of at least 6 months
• • Written informed consent that is not consistent with ICH-GCP (International Conference on Harmonisation - Good Clinical Practice) guidelines and local requirements
• Exclusion Criteria:
• • Participation in another clinical study within the past 4 weeks before start of therapy or concomitantly with this study
• • Radiotherapy within 4 weeks before the start of therapy
• • Chemotherapy, immunotherapy or hormonal therapy (with the exception of hormonal replacement therapy) within 4 weeks before the start of the therapy
• • Patients with germ cell tumours, early stage ovarian cancer (Fédération Internationale de Gynécologie et d'Obstétrique \[FIGO\] stage I-IIA), primary cervical cancer (FIGO I-III), primary endometrial cancer (FIGO I-III) or borderline tumours
• • Patients with known brain metastases
• • Symptomatic bowel obstruction or known or suspected malabsorption
• • Patients with pericardial effusion which is haemodynamically relevant
• • Other malignancy diagnosed within the past 5 years (other than non-melanomatous skin cancer or cervical carcinoma in situ)
• • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study medication
• • History of haemorrhagic or thrombotic event (including transient ischemic attacks) in the past 6 months
• • Concurrent therapeutic anticoagulation or anti-platelet therapy (except chronic low dose daily acetylsalicylic acid \<300 mg)
• • Major injuries and surgeries within the past 3 weeks, planned surgical procedures during the trial, incomplete wound healing
• • Known hypersensitivity to paclitaxel, carboplatin, BIBF 1120 or any of their excipients or vehicles such as polyoxyethylated castor oil
• • Clinically significant peripheral polyneuropathy (\>CTCAE grade 1) which precludes therapy with paclitaxel
• • Absolute neutrophil count (ANC) \<1500/μL, platelet count \<100000/μL, or haemoglobin \<9 mg/dL
• • Total bilirubin \>1.5 mg/dL (26 μmol/L), ALT (Alanine aminotransferase) and/or AST (Aspartate aminotransferase) \>1.5 x the upper limit of normal (ULN)
• • Serum creatinine \>1.5 mg/dL (\>132 μmol/L)
• • Persistent gross haematuria
• • Pregnancy or breast feeding
• • Women with childbearing potential and who are sexually active and unwilling to use a medically acceptable method of contraception (oral contraceptive, diaphragm with spermicide, intrauterine device, condom with spermicide)
• • Known or suspected active drug or alcohol abuse