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COMPLETEDPHASE2

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)

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)

NCT01362361•Martin-Luther-Universität Halle-Wittenberg

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

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 more criteria

Locations (12)

Universitätsklinikum Halle

Halle, Saxony-Anhalt, Germany

Schwerpunktpraxis für Hämatologie und Onkologie Bottrop und Dorsten

Bottrop, Germany

Kliniken der Stadt Köln gGmbH - Krankenhaus Holweide

Cologne, 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

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

Key Dates

Start Date

June 1, 2011

Primary Completion Date

June 1, 2016

Completion Date

December 1, 2016

Last Updated

September 19, 2019

Enrollment

ACTUAL participants

Conditions

Colorectal Cancer

Interventions

mFOLFOX6 + BIBF 1120

DRUG

mFOLFOX6+placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors