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Cancer research

Belinostat Enters Phase 1/2 Trial as Combination Therapy for Advanced or Recurrent Thymic Malignancies

Strategic Insights

— 1 min read

The National Cancer Institute (NCI)-sponsored Phase 1/2 trial of belinostat in combination with cisplatin, doxorubicin, and cyclophosphamide for the first-line treatment of advanced or recurrent thymic malignancies has begun dosing patients. This trial aims to determine the safe doses of the combination therapy in patients and provide recommendations for future clinical trials. The NCI has chosen belinostat for investigation due to its potential as an effective treatment in combination with existing chemotherapeutic agents for thymomas, thymic malignancies, and other cancers.

Key Takeaways:

  • The Phase 1/2 trial is designed to recruit between 30 and 48 evaluable patients and will investigate the safety and efficacy of belinostat in combination with cisplatin, doxorubicin, and cyclophosphamide in the first-line treatment of advanced or recurrent thymic malignancies.
  • Belinostat is a novel histone deacetylase (HDAC) inhibitor with a potential for effective treatment in combination with existing chemotherapeutic agents for thymomas, thymic malignancies, and other cancers.
  • The trial is among the first to test the feasibility of administering belinostat with common chemotherapy agents in the first-line treatment of advanced or recurrent thymic malignancies.
  • Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals, stated that the company is pleased with the NCI's continued investigation of belinostat's use in cancer treatment.
  • Belinostat has been granted Orphan Drug and Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of Peripheral T-Cell Lymphoma (PTCL).

Sources:

  • Spectrum Pharmaceuticals, Inc.
  • "About the Belinostat Registrational Study"
  • National Cancer Institute (NCI)
  • Angiogenesis Weekly
  • NewsRx.com

Statistics:

  • The trial aims to recruit between 30 and 48 evaluable patients.
  • Belinostat is one of the first HDAC inhibitors in clinical development with multiple potential routes of administration, including intravenous administration, continuous intravenous infusion, and oral administration.
  • The NCI has chosen belinostat for investigation due to its potential as an effective treatment in combination with existing chemotherapeutic agents for thymomas, thymic malignancies, and other cancers.

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