NCT01362361

Brief Summary

The purpose of this study: To explore the comparative effectiveness of BIBF 1120 in terms of :

  • Progression-free survival (PFS), objective response, overall survival
  • Evaluate and compare safety

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P50-P75 for phase_2 colorectal-cancer

Timeline
Completed

Started Jun 2011

Longer than P75 for phase_2 colorectal-cancer

Geographic Reach
1 country

12 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

May 25, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 30, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

5 years

First QC Date

May 25, 2011

Last Update Submit

September 18, 2019

Conditions

Colorectal Cancer

Keywords

Second line colorectal cancer

Outcome Measures

Primary Outcomes (1)

  • progression free survival

    1 year

Study Arms (2)

Arm A

EXPERIMENTAL

mFOLFOX6 + BIBF 1120

Drug: mFOLFOX6 + BIBF 1120

Arm B

PLACEBO COMPARATOR

mFOLFOX6+placebo

Drug: mFOLFOX6+placebo

Interventions

mFOLFOX6 + BIBF 1120DRUG

mFOLFOX6 + BIBF1120 (2x200 mg/d d1-d14) (repeated every 14 days)

Arm A
mFOLFOX6+placeboDRUG

mFOLFOX6 + placebo (2x200 mg/d d1-d14) (repeated every 14 days)

Arm B

Eligibility Criteria

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

You may qualify if:

  • Histologically proven colorectal adenocarcinoma
  • Intended treatment with mFOLFOX6 after one prior palliative chemotherapy for metastatic CRC
  • Age \> 18 years
  • Metastatic disease not suitable for curative-intent surgery
  • Measurable (\> 1 cm) and evaluable disease (according to RECIST 1.1 criteria)
  • Prior bevacizumab, cetuximab or panitumumab are allowed.
  • ECOG performance status 0 or 1 (see appendix 10.4)
  • Adequate hepatic function
  • Adequate Renal function
  • Adequate bone marrow function
  • Other lab parameters: proteinuria \< CTCAE grade 2, Prothrombin time and/or partial thromboplastin time \< 50 % deviation from normal limits
  • Life expectancy at least 3 months
  • Signed and dated written informed consent prior to admission to the study in accordance with ICH-GCP guidelines and to the local legislation

You may not qualify if:

  • Known hypersensitivity to the trial drugs or their excipients.
  • Treatment with any investigational drug within 28 days of trial onset.
  • Prior treatment with more than one line of palliative standard chemotherapy for colorectal cancer, prior treatment with a tyrosine kinase inhibitor, prior palliative treatment with an oxaliplatin-containing regime.
  • History of other malignancies in the last 5 years, in particular those which could affect compliance with the protocol or interpretation of results. Patients with adequately treated basal or squamous cell skin cancer are generally eligible.
  • Serious concomitant disease, especially those that would limit compliance with trial requirements or which are considered relevant for the evaluation of the efficacy or safety of the trial drug, such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with trial participation or trial drug administration, and in the judgment of the investigator would make the patient inappropriate for entry into the trial.
  • Significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction within past 9 months, congestive heart failure \> NYHA II) (see appendix 10.3).
  • History of severe haemorrhagic or thrombotic events in the past 12 months (excluding central venous catheter thrombosis and peripheral deep vein thrombosis). Known inherited predisposition to bleeds or to thrombosis.
  • Patient with brain metastases that are symptomatic and/or require therapy.
  • Therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except for chronic low-dose therapy with acetylsalicylic acid ≤ 325mg per day)
  • History of major thrombotic or clinically relevant major bleeding event in the past 6 months
  • Current peripheral neuropathy ≥ CTCAE grade 2 except due to trauma
  • Serious infections requiring systemic antibiotic (e.g antiviral, antimicrobial, antifungal) therapy
  • Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
  • Active alcohol or drug abuse.
  • Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Universitätsklinikum Halle

Halle, Saxony-Anhalt, 06120, Germany

Location

Schwerpunktpraxis für Hämatologie und Onkologie Bottrop und Dorsten

Bottrop, Germany

Location

Kliniken der Stadt Köln gGmbH - Krankenhaus Holweide

Cologne, Germany

Location

Universitätsklinikum Greifswald -Klinik für Innere Medizin A

Greifswald, Germany

Location

Gemeinschaftspraxis und Tagesklinik Onkologie und Gastroenterologie - Halle

Halle, Germany

Location

Klinikum Karlsruhe, Medizinische Klinik III

Karlsruhe, Germany

Location

Universitätsmedizin Mannheim - TTZ am Interdisziplinären Tumorzentrum

Mannheim, Germany

Location

Joh. Wesling Klinikum Minden

Minden, Germany

Location

Stauferklinikum Schwäbisch Gmünd - Mutlangen - Zentrum Innere Medizin

Mutlangen, Germany

Location

Klinikum der Universität München-Großhadern - Medizinische Klinik und Poliklink III

München, Germany

Location

Leopoldina-Krankenhaus Schweinfurt - Medizinische Klinik 2

Schweinfurt, Germany

Location

Universitätsklinikum Ulm - Klinik für Innere Medizin I

Ulm, Germany

Location

Related Publications (1)

  • Ettrich TJ, Perkhofer L, Decker T, Hofheinz RD, Heinemann V, Hoffmann T, Hebart HF, Herrmann T, Hannig CV, Buchner-Steudel P, Guthle M, Hermann PC, Berger AW, Seufferlein T. Nintedanib plus mFOLFOX6 as second-line treatment of metastatic, chemorefractory colorectal cancer: The randomised, placebo-controlled, phase II TRICC-C study (AIO-KRK-0111). Int J Cancer. 2021 Mar 15;148(6):1428-1437. doi: 10.1002/ijc.33296. Epub 2020 Oct 4.

    PMID: 32930387DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

nintedanib

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

May 25, 2011

First Posted

May 30, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

September 19, 2019

Record last verified: 2019-09

Locations

DE(12)