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

NCT02182245 | Completed Phase 1

• 1 other identifier: 1199.6
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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

Conditions

Genital Neoplasms, Female

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD) of BIBF 1120

  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

  up to 9 months

Secondary Outcomes (3)

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

  up to 9 months

• Cancer antigen 125 (CA-125) response

  Day 1 of each treatment period

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

  up to 9 months

Study Arms (2)

Combination Therapy

EXPERIMENTAL

Drug: BIBF 1120; Drug: Paclitaxel; Drug: Carboplatin

Monotherapy

EXPERIMENTAL

Drug: BIBF 1120

Interventions

BIBF 1120 DRUG

Combination Therapy; Monotherapy

Paclitaxel DRUG

Combination Therapy

Carboplatin DRUG

Combination Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Related Links

• Related Info

MeSH Terms

Conditions

Genital Neoplasms, Female

Interventions

nintedanib; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 8, 2014
• Study Start: October 1, 2005
• Primary Completion: January 1, 2007
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share