CompletedPhase 1

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

22 participantsStarted 2005-10-01

Plain-language 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

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 malabs…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum tolerated dose (MTD) of BIBF 1120

Timeframe: up to 126 days

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

Trial details

NCT IDNCT02182245

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-01-01

View on ClinicalTrials.gov More Genital Neoplasms, Female trials