Regorafenib in Patients With Refractory Primary Bone Tumors

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Brief Title

Regorafenib in Patients With Refractory Primary Bone Tumors

Official Title

Evaluation of the Efficacy and Safety of Regorafenib in Patients With Refractory Primary Bone Tumors

Brief Summary

      The aim of the project is to improve treatment outcomes in patients with primary malignant
      bone tumors, refractory to standard therapy, by increasing the availability of advanced
      therapy, as well as to develop treatment options using advanced molecular diagnostics for
      patients who have not responded to the standard therapeutic regimen, and to introduce modern
      diagnostics for risk stratification and for the use in molecularly targeted therapies.
    

Detailed Description

      The scope of the project is to cover the entire population of children, adolescents and young
      adults from the age of 2 to the age of 21, who progressed to first-line treatment or who
      presented with a recurrence of Ewing's sarcoma or osteosarcoma. Despite escalating doses of
      chemotherapy and radiotherapy, aggressive surgical procedures in patients with dissemination
      disease and negative prognostic factors, no improvement in treatment outcomes has been
      achieved for over 30 years. For this reason, other therapeutic options are being
      investigated. There have been no significant responses to immunotherapy. Although, the
      inclusion of tyrosine kinase inhibitors (TKIs) appears to be promising.

      The identification of new mutations in bone tumors has led to a better insight into the
      molecular basis of these tumors, which has resulted in a more significant role of genetic
      research in everyday practice. Although traditional histopathological examinations are
      currently the basis for the diagnosis of bone tumors, the developing techniques of molecular
      biology make it possible, in many cases, to refine the diagnosis and, in the near future,
      will become the basis for the classification of these neoplasms. Moreover, these technics are
      expected to enable the qualification of patients to modern molecularly targeted therapies.

      Based on the above data, the objectives of the project are as follows: 1. to estimate the
      nature and frequency of mutations in the tumor tissue, 2. to compare molecular test results
      with clinical data (which will allow for the initial assessment of the impact of the mutation
      status on the clinical condition, course of treatment and prognosis), 3. to include targeted
      treatment - broad spectrum tyrosine kinase inhibitor - regorafenib in standard therapy.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

EFS - (Event-Free Survival).

Secondary Outcome

 PFS (Progression-Free Survival).

Condition

Osteosarcoma

Intervention

Regorafenib

Study Arms / Comparison Groups

 R1 - Regorafenib Arm
Description:  R1 - the experimental group. Standard oncological treatment will be started. Additionally, patients will receive regorafenib orally at doses adjusted for age, body surface area and pharmacokinetics. Treatment with regorafenib will be continued for up to 1 year or until disease progression, patient death, unacceptable toxicity, or study closure. Pharmacokinetics and safety profile of the investigational product (IP) will be determined throughout the course therapy.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

30

Start Date

April 28, 2022

Completion Date

December 31, 2025

Primary Completion Date

September 12, 2025

Eligibility Criteria

        Inclusion Criteria:

          1. Age >9 years ≤ 21 years.

          2. Histologically proven Ewing sarcoma or osteosarcoma.

          3. Failure of the treatment identified no earlier than 30 days prior to study treatment
             initiation (at least one of below needs to apply in order for this requirement to be
             satisfied):

               1. progression on the I line or next, or

               2. relapse.

          4. Signing of informed consent for trial participation (including for Regorafenib
             treatment) according with current legal regulations.

          5. Life expectancy of at least 12 weeks from the time informed consent was signed.

          6. Possibility of swallowing the tablet.

          7. Consent to the use of effective contraception throughout the period of the study and a
             minimum of 2 year after discontinuation of study treatment in patients at puberty and
             sexual maturity.

        Exclusion Criteria:

          1. Lack of inclusion criteria

          2. Previous treatment with Regorafenib.

          3. Pregnancy and breastfeeding.

          4. Hypersensitivity to the study drug or any of its ingredients.

          5. Simultaneous treatment with other drugs which might interact with Regorafenib.

          6. Persistent toxicity related to prior therapy, making it impossible to treat with
             Regorafenib.

          7. Diagnosis of other malignancies before study inclusion.

          8. Patients with uncontrolled hypertension.

          9. Patients with diseases of the coagulation system.

         10. Patients with heart defects and / or cardiac arrhythmias requiring permanent treatment
             with antiarrhythmic drugs.

         11. Other acute or persistent disorders, behaviors or abnormal laboratory test results,
             which might increase the risk related to the participation in this clinical trial or
             to taking the study drug, or which might influence the interpretation of the study
             results, or which, in the investigator's opinion, disqualify a patient from
             participating in the trial.
      

Gender

All

Ages

9 Years - 21 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Poland

Location Countries

Poland

Administrative Informations


NCT ID

NCT05395741

Organization ID

Regbone


Responsible Party

Principal Investigator

Study Sponsor

Institute of Mother and Child, Warsaw, Poland

Collaborators

 Maria Sklodowska-Curie National Research Institute of Oncology

Study Sponsor

, , 


Verification Date

May 2022