Phase 3 Study of TAVT-45 in patients with metastatic prostate cancer

• Research type

  Research Study

• Full title

  Phase 3 study investigating the efficacy and safety of TAVT-45 (abiraterone acetate) Granules for Oral Suspension (a novel abiraterone acetate formulation) relative to a reference abiraterone acetate formulation in patients with metastatic Castrate Sensitive Prostate Cancer (mCSPC) and metastatic Castrate Resistant Prostate Cancer (mCRPC)

• IRAS ID

  294508

• Contact name

  Sarah Needleman

• Contact email

  sarah.needleman@nhs.net

• Sponsor organisation

  Tavanta Therapeutics Inc

• Eudract number

  2020-005611-46

• Clinicaltrials.gov Identifier

  139118, IND Number

• Duration of Study in the UK

  1 years, 1 months, 30 days

• Research summary

  Summary of Research
  The purpose of this study is to compare the study drug (TAVT-45), a new soluble granular formulation of abiraterone acetate, with the commercially available tablet form known as Zytiga. The drug will be given to patients within the current licensed indications of metastatic Castrate Resistant Prostate Cancer (mCRPC) and metastatic Castrate Sensitive Prostate Cancer (mCSPC), to establish whether it is as safe and effective. The study will enrol 108 patients from approximately 36 sites in the EU and USA (up to 5 sites in the UK). Patients will be in the study for approximately 17 weeks. This will include a screening period of up to 28 days, a treatment period of 84 days and a follow-up period of 1 week.

  Summary of Results
  : Tavanta Therapeutics, Inc. (the study sponsor), on behalf of the Contract Research Organization TMC and its subcontractors, thanks all patients, site personnel and investigators for participating in the completed study: “Phase 3 study investigating the efficacy and safety of TAVT-45 (abiraterone acetate) Granules for Oral Suspension (a novel abiraterone acetate formulation) relative to a reference abiraterone acetate formulation in patients with metastatic Castrate Sensitive Prostate Cancer (mCSPC) and metastatic Castrate Resistant Prostate Cancer (mCRPC) ”. Abiraterone acetate is on the World Health Organization’s (WHO) list of essential medicines since 2019. The medication stops the synthesis of testosterone, a critical driver of prostate cancer in men.
  The 12-week study evaluated a new formulation of abiraterone called TAVT-45, which can be dissolved in water or juice and taken with or without food. It was compared to the original tablet formulation, which must be taken on an empty stomach. The trial looked at the drugs’ ability to suppress testosterone synthesis on days 9&10, and also compared the safety profile.
  One hundred-three male patients with castrate-resistant or high-risk castrate-sensitive prostate cancer participated in the study, half received the oral solution twice daily (TAVT-45), and the other half received the tablet once a day (reference). Testosterone values declined dramatically with both formulations and were comparably low by days 9&10. There was also no difference in the suppression of prostate-specific antigen (PSA), a key marker of prostate cancer, by the end of the study after week 12. Both formulations were generally safe and well tolerated, and the most common safety findings included high blood pressure, changes in liver enzymes, and swelling in the legs and hands. The new “drinkable” formulation of abiraterone will be an alternative formulation for patients with prostate cancer who have difficulty swallowing.
  The study took place in the USA, England, France, Sweden, Poland, Hungary and Spain between May 2021 to October 2022. Results of the study are being presented at the annual American Society for Clinical Oncology (ASCO) 2023 meeting in Chicago and will also be available on public trial registries (https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrials.gov%2F&data=05%7C01%7Capprovals%40hra.nhs.uk%7Cd090435d256a46076e0e08db629bea29%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638212194010049404%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=mTIDksoZiDdidmeNmctAPgpN0KQ0NcmFY5q36%2FfBTyE%3D&reserved=0 and https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrialsregister.eu%2F&data=05%7C01%7Capprovals%40hra.nhs.uk%7Cd090435d256a46076e0e08db629bea29%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638212194010049404%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=jZEPm47W0y9apUVgcP6ER7iHhp0%2FbNY%2FWuIC7IA7ypA%3D&reserved=0). Tavanta will submit the study results to relevant regulatory authorities to obtain marketing authorization.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  21/NW/0074

• Date of REC Opinion

  4 May 2021

• REC opinion

  Further Information Favourable Opinion