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Genital Neoplasms, FemalePhase 1NCT02182245

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

A Phase 1 study testing BIBF 1120, Paclitaxel and Carboplatin in people with Genital Neoplasms, Female, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Genital Neoplasms, Female
What is being tested?
BIBF 1120, Paclitaxel and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
No sites listed yet
Study dates
1 Oct 2005to 1 Jan 2007
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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

About this study

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

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

Being tested
BIBF 1120, Paclitaxel, Carboplatin
Medical subject headings
Genital Neoplasms, Female

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02182245
Study groupRoleWhat they receive
Combination TherapyExperimentalNot described
Receives: Drug: BIBF 1120; Drug: Paclitaxel; Drug: Carboplatin
MonotherapyExperimentalNot described
Receives: Drug: BIBF 1120

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD) of BIBF 1120

    Measured: up to 126 days

  2. 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

    Measured: up to 9 months

Secondary outcomes (3)

  1. Objective tumour response after treatment with BIBF 1120 in combination with carboplatin and paclitaxel in evaluable patients

    Measured: up to 9 months

  2. Cancer antigen 125 (CA-125) response

    Measured: Day 1 of each treatment period

  3. Time to tumour progression (time from treatment start to the time of documented tumour progression)

    Measured: up to 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2014 (estimated)
  2. Study start1 Oct 2005
  3. Primary completion1 Jan 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02182245
Sponsor's protocol ID
1199.6
Status last verified
Jan 2025
First submitted
2 Jul 2014
Last updated
23 Jan 2025
Results posted
No
Individual data sharing
No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BIBF 1120, Paclitaxel and Carboplatin in people with Genital Neoplasms, Female, run by Boehringer Ingelheim.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) of BIBF 1120 (time frame: up to 126 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02182245.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.

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