ANITA (EORTC 1506)

• Research type

  Research Study

• Full title

  A Phase II multicenter study comparing the efficacy of the oral angionenesis inhibitor nintedanib with the intravenous cytotoxis compound ifosfamide for treatment of patients with advanced metastatic soft tissue sarcoma after failure of systemic non-oxazaphosporine-based first line chemotherapy for inoperable disease (ANITA)

• IRAS ID

  226582

• Contact name

  Charlotte Benson

• Contact email

  Charlotte.Benson@rmh.nhs.uk

• Sponsor organisation

  European Organisation for Research and Treatment of

• Eudract number

  2016-002093-12

• Clinicaltrials.gov Identifier

  NCT02808247

• Duration of Study in the UK

  2 years, 11 months, 30 days

• Research summary

  Summary of Research

  This study is for adults who have advanced, inoperable or metastatic soft tissue sarcoma that has worsened following chemotherapy. People whose cancer doesn't go away after chemotherapy are usually treated with additional chemotherapy. This is usually with a drug called ifosfamide, which is considered the ‘standard’ treatment in this situation. The purpose of this study is to find out whether giving the drug nintedanib is better at working against this disease than ifosfamide. This is measured by the length of time that participants live with the disease before it gets worse (progression-free survival).

  There is a need to investigate alternative treatments for this group of people as ifosfamide has potentially severe side effects, is relatively difficult and costly to administer (in an in-patient setting, requiring experienced staff and support care), and the anti-tumour activity in this group of people is unsatisfactory. Nintedanib is generally well tolerated, is already used to treat certain types of lung cancer, and is administered orally by the patients themselves at home.

  The study will compare the effects of nintedanib with ifosfamide using clinical examinations, regular scans and blood tests. Tumour samples and blood tests will also be used to understand the effects of the drug.

  This study will take place in NHS sites in the UK as part of a wider international study. The study is sponsored and coordinated by a non-profit organisation called the EORTC (European Organisation for Research and Treatment of Cancer), based in Brussels.

  Summary of Results

  This study was for adults who’s soft tissue sarcoma had grown into surrounding tissues or spread elsewhere in the body. This is called advanced or metastatic cancer. These patients cannot be treated by surgery, they need to receive chemotherapy. This study was open to patients who received a first type of chemotherapy, but their tumor had started to grow again. When this happens, people are treated with other chemotherapy, sometimes with a treatment called ifosfamide. However, ifosfamide can have severe side effects. It needs to be administered in the hospital.

  Nintedanib is a targeted cancer drug. It is a cancer growth blocker. It blocks particular proteins called protein kinases on the cancer cells. The protein kinases encourage the cancer to grow. Nintedanib blocks a number of these proteins and is called a multi kinase inhibitor. It also stops the cancer cells growing their own blood vessels, which the cells need to be able to grow. Nintedanib may shrink the cancer or stop it growing for a time. It is already used to treat certain types of lung cancer. It is a capsule that is swallowed whole with a glass of water. It can be taken at home.  (Nintedanib | Cancer information | Cancer Research UK)

  The main aims of the ANITA study were to find out:

  -whether giving nintedanib works better than ifosfamide.
  -compare the side effects of nintedanib to those of ifosfamide.

  In this study, patients could be randomly assigned to receive either nintedanib or ifosfamide. Patients receiving nintedanib, took pills for as long as it worked and the side effects weren’t too bad. The other group of participants received Ifosfamide for as long as it worked and the side effects weren’t too bad, for a maximum of approximately 5 months (6 cycles).

  Summary of the results:

  Eighty patients participated to this study.

  Forty participants were scheduled to receive nintedanib, one patient did not start treatment (as the study was put on hold). The majority of patients stopped treatment because it stopped working. Two patients stopped treatment because the side effects were too bad.

  Some of the common side effects of nintedanib included:

  -tummy (abdominal) pain
  -diarrhoea
  -feeling or being sick
  -feeling tired
  -high blood pressure

  Forty participants were scheduled to receive ifosfamide treatment, two did not start treatment. One out of 3 patients completed the 6 cycles of treatments. One out of 4 patients stopped treatment because it stopped working. One out of 4 stopped because the side effects were too bad.

  Some of the common side effects of ifosfamide included:

  -constipation
  -feeling or being sick
  -feeling tired
  -loss of weight
  -confusion and mind changes
  -hair loss

  For 14 patients the nintedanib had stopped working after 12 weeks of treatment. For 18 patients ifosfamide had stopped working after 12 weeks of treatment. Given these results, the trial team concluded that nintedanib did not slow cancer growth as much as the researchers had hoped. They closed the study.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  17/LO/1383

• Date of REC Opinion

  17 Oct 2017

• REC opinion

  Further Information Favourable Opinion