ANITA

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ANITA - Nintedanib with Ifosfamide in advanced, metastatic Soft Tissue Sarcoma (STS)

Agents: Nintedanib vs. Ifosfamide
Phase II
Status  Closed, active
Sponsor EORTC in collaboration with Boehringer Ingelheim

 

Further information: https://clinicaltrials.gov/ct/show/NCT02808247 or http://www.eortc.org/research_field/clinical-detail/1506/

 

 

A Phase II study comparing Nintedanib with Ifosfamide in patients with advanced, metastatic Soft Tissue Sarcoma (STS) after failure of specific first line chemotherapy

WHO is the trial for?
  • Adult patients (18 years or older) with intermediate or high grade soft tissue sarcoma that is inoperable or with metastasis and progressing
  • Excluded are specific subtypes such as well-differentiated liposarcoma/atypical lipoma, rhabdomyosarcoma, chondrosarcoma, osteosarcoma, Ewing sarcomas, GIST or Dermatofibrosarcoma protuberans. Please consult your doctor for more specific information
  • Patients should have received at least one line of chemotherapy before study entry
  • Tumor tissue should be available for histological central review
  • Adequate bone marrow, liver and renal function and coagulation parameters
  • Overall health status of the patient has to be good (WHO performance status 0-2)

WHAT is the key question that this trial is attempting to answer?

This trial tries to answer the question if treatment with nintedanib is superior to a chemotherapy agent called ifosfamide in patients with advanced, inoperable and/or metastatic STS after a first line chemotherapy failed.

The time till disease progression will be assessed, but also safety and tolerability, and the impact on overall survival.

WHY patients might want to participate?

 This clinical trial offers patients an opportunity to access a new therapy strategy and will further support the research in sarcomas and potentially help other patients with this disease. The trial might or might not have benefit in your individual case. For more about the importance and benefits of joining clinical trials, please click here.

WHEN will the trial be open?

 The study is closed for patient recruitment, but still active

WHERE is the trial available?

The trial is available in several study centers in the Belgium, France, Poland, The Netherlands, Spain, Lithuania and the UK. For further information please check here: http://www.eortc.org/research_field/clinical-detail/1506/

Study contact:

  • Ward Sents, EORTC:
    Phone: +32 2 7741533
    E-Mail: Αυτή η διεύθυνση ηλεκτρονικού ταχυδρομείου προστατεύεται από τους αυτοματισμούς αποστολέων ανεπιθύμητων μηνυμάτων. Χρειάζεται να ενεργοποιήσετε τη JavaScript για να μπορέσετε να τη δείτε.

STUDY DESIGN: What does the study look like?

There will be 2 study arms (groups): all participating patients will be randomly divided (by a computer) in two groups.

Patients in one group will be assigned to nintedanib, patients in the other group will receive ifosfomide.

HOW do I get more information?

 Patient organisations supporting sarcoma patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving GIST and/or sarcoma patients. If there are no such organisation in your country, please email us for more information: Αυτή η διεύθυνση ηλεκτρονικού ταχυδρομείου προστατεύεται από τους αυτοματισμούς αποστολέων ανεπιθύμητων μηνυμάτων. Χρειάζεται να ενεργοποιήσετε τη JavaScript για να μπορέσετε να τη δείτε.

CONNECT with other patients on this trial

 If you want to connect with other patients considering or participating in this trial, you can find them here: List of organisations worldwide.

SHARE your experience

 You want to share your experience on this trial?
Send us an e-mail to: Αυτή η διεύθυνση ηλεκτρονικού ταχυδρομείου προστατεύεται από τους αυτοματισμούς αποστολέων ανεπιθύμητων μηνυμάτων. Χρειάζεται να ενεργοποιήσετε τη JavaScript για να μπορέσετε να τη δείτε.
Note that your experience would be helpful for other patients and patient organisations.

RESULTS of the study

 No results are available at this time. Future results will be linked here.


Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken