Clinical trial NCT02182245: Dose Escalation Study of BIBF 1120 in Patients With Advanced Gynaecological Malignancies
Official title: A Phase I Open Label Dose Escalation Study of Oral Treatment With BIBF 1120 in Combination With Standard Treatment of Paclitaxel and Carboplatin in Patients With Advanced Gynaecological Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Genital Neoplasms, Female
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


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

Primary outcomes:
measure: Maximum tolerated dose (MTD) of BIBF 1120
timeFrame: up to 126 days
measure: Incidence and intensity of adverse events according to the CTCAE (Common terminology criteria for adverse events Version) version 3.0 with increasing doses of BIBF 1120
timeFrame: up to 9 months
Secondary outcomes:
measure: Objective tumour response after treatment with BIBF 1120 in combination with carboplatin and paclitaxel in evaluable patients
timeFrame: up to 9 months
measure: Cancer antigen 125 (CA-125) response
timeFrame: Day 1 of each treatment period
measure: Time to tumour progression (time from treatment start to the time of documented tumour progression)
timeFrame: up to 9 months
Other outcomes:
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