NCT00987935

Brief Summary

This study is to evaluate the safety, appropriate dose, and efficacy of BIBF 1120 in liver cancer patients

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2009

Longer than P75 for phase_2

Geographic Reach
2 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 27, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 10, 2016

Status Verified

February 1, 2016

Enrollment Period

4.8 years

First QC Date

September 30, 2009

Results QC Date

June 3, 2015

Last Update Submit

February 9, 2016

Conditions

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (2)

  • Maximum Tolerated Dose in Phase I

    The MTD was defined as the highest dose studied for which the incidence of DLTs was 0/3 or less than 2/6 patients during the first treatment course.

    4 weeks

  • Time to Progression (TTP) in Phase II

    TTP according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.0 criteria based on central independent review. TTP RECIST 1.0 was defined as the time from randomisation to disease progression according to RECIST 1.0.

    From randomization until data cut-off (28 Sep 2012); Up to 77 weeks

Secondary Outcomes (13)

  • Time to Progression (TTP) in Phase II (Follow-up Analyses)

    From randomization until disease progression or data cut-off (16 Jul 2014); Up to 171 weeks

  • Incidence and Intensity of Adverse Events (AEs) Reported as the Number of Patients With AEs According to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Throughout the Treatment Period.

    AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)

  • Incidence of Dose Limiting Toxicity in Phase I

    4 weeks

  • Objective Tumour Response by RECIST

    From randomization until data cut-off (16 July 2014); Up to 171 weeks

  • Progression Free Survival (PFS)

    From randomization until data cut-off (16 July 2014); Up to 171 weeks

  • +8 more secondary outcomes

Study Arms (2)

Nintedanib (BIBF 1120)

EXPERIMENTAL

Phase I dose escalation and phase II using dose determined in phase I

Drug: BIBF 1120

Sorafenib

ACTIVE COMPARATOR

Twice daily dosing in phase II

Drug: Sorafenib

Interventions

SorafenibDRUG

400 mg twice daily

Sorafenib
BIBF 1120DRUG

Twice daily

Nintedanib (BIBF 1120)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hepatocellular carcinoma, either histologically/cytologically confirmed or clinically diagnosed, which is not amenable to curative surgery or loco-regional therapy
  • Age 18 years or older
  • Eastern Cooperative Group performance score of 2 or less
  • Child-Pugh score of 7 or less
  • Written informed consent in accordance with International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP) and local legislation

You may not qualify if:

  • Prior systemic therapy for metastatic/unresectable hepatocellular carcinoma (for phase II)
  • More than one line of prior systemic therapy for metastatic/unresectable hepatocellular carcinoma (for phase I)
  • Uncontrolled or refractory ascites to adequate medical therapy
  • Bilirubin greater than 1.5 times upper limit of normal
  • Aspartate amino transferase or alanine amino transferase greater than 5 times upper limit of normal
  • Absolute neutrophil count less than 1500/microliter
  • Platelet count less than 75000/microliter
  • Hemoglobin less than 9 g/dL
  • Serum creatinine greater than 1.5 times upper limit of normal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

1199.39.82001 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1199.39.82002 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1199.39.82003 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1199.39.82004 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1199.39.82005 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1199.39.82006 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1199.39.88606 Boehringer Ingelheim Investigational Site

Changhua, Taiwan

Location

1199.39.88609 Boehringer Ingelheim Investigational Site

Kaohsiung City, Taiwan

Location

1199.39.88610 Boehringer Ingelheim Investigational Site

Kaohsiung City, Taiwan

Location

1199.39.88605 Boehringer Ingelheim Investigational Site

Taichung, Taiwan

Location

1199.39.88602 Boehringer Ingelheim Investigational Site

Tainan, Taiwan

Location

1199.39.88608 Boehringer Ingelheim Investigational Site

Tainan, Taiwan

Location

1199.39.88601 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1199.39.88603 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1199.39.88604 Boehringer Ingelheim Investigational Site

Taoyuan, Taiwan

Location

1199.39.88607 Boehringer Ingelheim Investigational Site

Yunlin County, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenibnintedanib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2009

First Posted

October 1, 2009

Study Start

October 1, 2009

Primary Completion

July 1, 2014

Study Completion

January 1, 2016

Last Updated

March 10, 2016

Results First Posted

August 27, 2015

Record last verified: 2016-02

Locations

TW(10)KR(6)