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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Genital Neoplasms, Female

Treatments

Drug: Carboplatin

Drug: Paclitaxel

Drug: BIBF 1120

Study type

Interventional

Funder types

Industry

Identifiers

NCT02182245

1199.6

Details and patient eligibility

About

The primary objectives of this trial were to determine the safety, tolerability, and MTD of BIBF 1120 when added to standard therapy with carboplatin and paclitaxel

Enrollment

22 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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