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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) (AIO-KRK-0111)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01362361
Recruitment Status : Completed
First Posted : May 30, 2011
Last Update Posted : September 19, 2019
Information provided by (Responsible Party):
Prof. Dr. med. Thomas Seufferlein, Martin-Luther-Universität Halle-Wittenberg

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

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: mFOLFOX6 + BIBF 1120 Drug: mFOLFOX6+placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Study Start Date : June 2011
Actual Primary Completion Date : June 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm A
mFOLFOX6 + BIBF 1120
Drug: mFOLFOX6 + BIBF 1120
mFOLFOX6 + BIBF1120 (2x200 mg/d d1-d14) (repeated every 14 days)

Placebo Comparator: Arm B
Drug: mFOLFOX6+placebo
mFOLFOX6 + placebo (2x200 mg/d d1-d14) (repeated every 14 days)

Primary Outcome Measures :
  1. progression free survival [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically proven colorectal adenocarcinoma
  2. Intended treatment with mFOLFOX6 after one prior palliative chemotherapy for metastatic CRC
  3. Age > 18 years
  4. Metastatic disease not suitable for curative-intent surgery
  5. Measurable (> 1 cm) and evaluable disease (according to RECIST 1.1 criteria)
  6. Prior bevacizumab, cetuximab or panitumumab are allowed.
  7. Previous adjuvant oxaliplatin-containing therapy is allowed, if the end of adjuvant chemotherapy is >12 months prior to inclusion into the trial
  8. ECOG performance status 0 or 1 (see appendix 10.4)
  9. Adequate hepatic function
  10. Adequate Renal function
  11. Adequate bone marrow function
  12. Other lab parameters: proteinuria < CTCAE grade 2, Prothrombin time and/or partial thromboplastin time < 50 % deviation from normal limits
  13. Life expectancy at least 3 months
  14. Signed and dated written informed consent prior to admission to the study in accordance with ICH-GCP guidelines and to the local legislation

Exclusion Criteria:

  1. Known hypersensitivity to the trial drugs or their excipients.
  2. Treatment with any investigational drug within 28 days of trial onset.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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).
  8. 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.
  9. Patient with brain metastases that are symptomatic and/or require therapy.
  10. 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)
  11. History of major thrombotic or clinically relevant major bleeding event in the past 6 months
  12. Current peripheral neuropathy ≥ CTCAE grade 2 except due to trauma
  13. Serious infections requiring systemic antibiotic (e.g antiviral, antimicrobial, antifungal) therapy
  14. Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
  15. Active alcohol or drug abuse.
  16. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
  17. Pregnancy or breast-feeding
  18. Leptomeningeal disease
  19. Radiographic evidence of cavitary or necrotic tumours
  20. Centrally located tumours with radiographic evidence (CT or MRI) of local invasion of major blood vessels
  21. 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01362361

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Universitätsklinikum Halle
Halle, Sachsen-Anhalt, Germany, 06120
Schwerpunktpraxis für Hämatologie und Onkologie Bottrop und Dorsten
Bottrop, Germany
Universitätsklinikum Greifswald -Klinik für Innere Medizin A
Greifswald, Germany
Gemeinschaftspraxis und Tagesklinik Onkologie und Gastroenterologie - Halle
Halle, Germany
Klinikum Karlsruhe, Medizinische Klinik III
Karlsruhe, Germany
Kliniken der Stadt Köln gGmbH - Krankenhaus Holweide
Köln, Germany
Universitätsmedizin Mannheim - TTZ am Interdisziplinären Tumorzentrum
Mannheim, Germany
Joh. Wesling Klinikum Minden
Minden, Germany
Stauferklinikum Schwäbisch Gmünd - Mutlangen - Zentrum Innere Medizin
Mutlangen, Germany
Klinikum der Universität München-Großhadern - Medizinische Klinik und Poliklink III
München, Germany
Leopoldina-Krankenhaus Schweinfurt - Medizinische Klinik 2
Schweinfurt, Germany
Universitätsklinikum Ulm - Klinik für Innere Medizin I
Ulm, Germany
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
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Responsible Party: Prof. Dr. med. Thomas Seufferlein, PI, Martin-Luther-Universität Halle-Wittenberg Identifier: NCT01362361    
Other Study ID Numbers: TRICC-C (AIO-KRK-0111)
2010-023050-37 ( EudraCT Number )
First Posted: May 30, 2011    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Keywords provided by Prof. Dr. med. Thomas Seufferlein, Martin-Luther-Universität Halle-Wittenberg:
Second line colorectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action