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AzTrials

Colorectal CancerPhase 2AIO-KRK-0111NCT01362361

TRICC-C (AIO-KRK-0111): BIBF 1120 Versus Placebo in Patients Receiving Oxaliplatin Plus Fluorouracil and Leucovorin (mFOLFOX6) for Advanced, Chemorefractory Metastatic Colorectal Cancer (mCRC)

A Phase 2 study testing mFOLFOX6 + BIBF 1120 in people with Colorectal Cancer, run by Martin-Luther-Universität Halle-Wittenberg at 12 sites in Germany.

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 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
mFOLFOX6 + BIBF 1120
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
12 sitesGermany
Study dates
Jun 2011to Dec 2016
Phase
Phase 2
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • Previous adjuvant oxaliplatin-containing therapy is allowed, if the end of adjuvant chemotherapy is >12 months prior to inclusion into the trial
  • 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

Who cannot join

  • 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.
  • Major injuries and/or surgery or bone fracture within 4 weeks of trial inclusion, or planned surgical procedures during the trial period. Portimplantation prior to therapy is allowed.
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  • 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
  • Pregnancy or breast-feeding
  • Leptomeningeal disease
  • Radiographic evidence of cavitary or necrotic tumours
  • Centrally located tumours with radiographic evidence (CT or MRI) of local invasion of major blood vessels
  • Severe chemotherapy-associated toxicity during or after adjuvant or palliative first-line chemotherapy like 5-FU-associated cardiac toxicity (coronary spasm) or persistent oxaliplatin-associated peripheral neuropathy (≥ CTCAE grade 2) with paresthesia associated with pain or functional impairment (after adjuvant oxaliplatin-containing chemotherapy).

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Germany12 sites

  • Schwerpunktpraxis für Hämatologie und Onkologie Bottrop und Dorsten

    Bottrop

  • Kliniken der Stadt Köln gGmbH - Krankenhaus Holweide

    Cologne

  • Universitätsklinikum Greifswald -Klinik für Innere Medizin A

    Greifswald

  • Universitätsklinikum Halle

    Halle, Saxony-Anhalt, 06120

  • Gemeinschaftspraxis und Tagesklinik Onkologie und Gastroenterologie - Halle

    Halle

  • Klinikum Karlsruhe, Medizinische Klinik III

    Karlsruhe

  • Universitätsmedizin Mannheim - TTZ am Interdisziplinären Tumorzentrum

    Mannheim

  • Joh. Wesling Klinikum Minden

    Minden

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

    München

  • Stauferklinikum Schwäbisch Gmünd - Mutlangen - Zentrum Innere Medizin

    Mutlangen

  • Leopoldina-Krankenhaus Schweinfurt - Medizinische Klinik 2

    Schweinfurt

  • Universitätsklinikum Ulm - Klinik für Innere Medizin I

    Ulm

Other trials in Germany

About this study

Official title: TRICC-C: A Multicenter, Randomized, Phase II Trial: BIBF 1120 vs. Placebo in Patients Receiving Oxaliplatin Plus Fluorouracil and Leucovorin (mFOLFOX6) for Advanced, Chemorefractory Metastatic Colorectal Cancer (mCRC)

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
Being tested
mFOLFOX6 + BIBF 1120, mFOLFOX6+placebo
Keywords
Second line colorectal cancer
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • mFOLFOX6 + BIBF 1120Drug

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

  • mFOLFOX6+placeboDrug

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

Study groups in NCT01362361
Study groupRoleWhat they receive
Arm AExperimentalmFOLFOX6 + BIBF 1120
Receives: Drug: mFOLFOX6 + BIBF 1120
Arm BPlacebo comparatormFOLFOX6+placebo
Receives: Drug: mFOLFOX6+placebo

What is being measured

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

  1. progression free survival

    Measured: 1 year

Timeline

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

  1. First posted30 May 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionJun 2016
  4. Study completionDec 2016

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01362361
Sponsor's protocol ID
TRICC-C (AIO-KRK-0111)
Other IDs
2010-023050-37
Acronym
AIO-KRK-0111
Status last verified
Sep 2019
First submitted
25 May 2011
Last updated
19 Sep 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 32930387

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing mFOLFOX6 + BIBF 1120 in people with Colorectal Cancer, run by Martin-Luther-Universität Halle-Wittenberg at 12 sites in Germany.

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 14 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 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

progression free survival (time frame: 1 year). 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 NCT01362361, which also lists 1 linked publication.

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 19 Sep 2019.

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