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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)

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ClinicalTrials.gov Identifier: NCT01362361
Recruitment Status : Completed
First Posted : May 30, 2011
Last Update Posted : September 19, 2019
Sponsor:
Collaborator:
GALMED GmbH
Information provided by (Responsible Party):
Prof. Dr. med. Thomas Seufferlein, Martin-Luther-Universität Halle-Wittenberg

Tracking Information
First Submitted Date  ICMJE May 25, 2011
First Posted Date  ICMJE May 30, 2011
Last Update Posted Date September 19, 2019
Study Start Date  ICMJE June 2011
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2011)
progression free survival [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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)
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: mFOLFOX6 + BIBF 1120
    mFOLFOX6 + BIBF1120 (2x200 mg/d d1-d14) (repeated every 14 days)
  • Drug: mFOLFOX6+placebo
    mFOLFOX6 + placebo (2x200 mg/d d1-d14) (repeated every 14 days)
Study Arms  ICMJE
  • Experimental: Arm A
    mFOLFOX6 + BIBF 1120
    Intervention: Drug: mFOLFOX6 + BIBF 1120
  • Placebo Comparator: Arm B
    mFOLFOX6+placebo
    Intervention: Drug: mFOLFOX6+placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2019)
54
Original Estimated Enrollment  ICMJE
 (submitted: May 27, 2011)
0
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01362361
Other Study ID Numbers  ICMJE TRICC-C (AIO-KRK-0111)
2010-023050-37 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. med. Thomas Seufferlein, Martin-Luther-Universität Halle-Wittenberg
Study Sponsor  ICMJE Martin-Luther-Universität Halle-Wittenberg
Collaborators  ICMJE GALMED GmbH
Investigators  ICMJE Not Provided
PRS Account Martin-Luther-Universität Halle-Wittenberg
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP