search
Back to results

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

Primary Purpose

Genital Neoplasms, Female

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
BIBF 1120
Paclitaxel
Carboplatin
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genital Neoplasms, Female

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Combination Therapy

    Monotherapy

    Arm Description

    Outcomes

    Primary Outcome Measures

    Maximum tolerated dose (MTD) of BIBF 1120
    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

    Secondary Outcome Measures

    Objective tumour response after treatment with BIBF 1120 in combination with carboplatin and paclitaxel in evaluable patients
    Cancer antigen 125 (CA-125) response
    Time to tumour progression (time from treatment start to the time of documented tumour progression)

    Full Information

    First Posted
    July 2, 2014
    Last Updated
    July 17, 2014
    Sponsor
    Boehringer Ingelheim
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02182245
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2005 (undefined)
    Primary Completion Date
    January 2007 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boehringer Ingelheim

    4. Oversight

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Genital Neoplasms, Female

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Combination Therapy
    Arm Type
    Experimental
    Arm Title
    Monotherapy
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    BIBF 1120
    Intervention Type
    Drug
    Intervention Name(s)
    Paclitaxel
    Intervention Type
    Drug
    Intervention Name(s)
    Carboplatin
    Primary Outcome Measure Information:
    Title
    Maximum tolerated dose (MTD) of BIBF 1120
    Time Frame
    up to 126 days
    Title
    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
    Time Frame
    up to 9 months
    Secondary Outcome Measure Information:
    Title
    Objective tumour response after treatment with BIBF 1120 in combination with carboplatin and paclitaxel in evaluable patients
    Time Frame
    up to 9 months
    Title
    Cancer antigen 125 (CA-125) response
    Time Frame
    Day 1 of each treatment period
    Title
    Time to tumour progression (time from treatment start to the time of documented tumour progression)
    Time Frame
    up to 9 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Links:
    URL
    http://trials.boehringer-ingelheim.com
    Description
    Related Info

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs