Phase 1 Study of DS-3078a in Patients with Advanced Cancers

• Research type

  Research Study

• Full title

  A Phase 1, Open-Label, Multiple Ascending Dose Study of DS-3078a, an Oral TORC1/2 Kinase Inhibitor, in Subjects with Advanced Solid Tumors or Lymphomas

• IRAS ID

  103599

• Contact name

  Udai Banerji

• Sponsor organisation

  Daiichi Sankyo Development Limited

• Eudract number

  2011-005988-24

• ISRCTN Number

  n/a

• Research summary

  Two potential targets for anti-cancer treatments are mTORC1 (mammalian target of rapamycin complex 1) and mTORC2 (mammalian target of rapamycin complex 2). Existing drugs which act on mTORC1 have been shown to provide clinical benefits in patients with renal cell (kidney) cancer and mantle cell lymphoma, but these drugs have limited activity in most other human cancers. The study drug DS-3078a acts on both mTORC1 and mTORC2 in laboratory tests and is therefore expected to show better anti-cancer effect when given to patients and may have a wider application than drugs which act on mTORC1 alone. The study drug has not previously been administered to humans so this study is designed to primarily investigate the safety and tolerability of DS-3078a at increasing dose levels to establish a dose which can be given without severe side effects to advanced cancer patients who have no further standard treatment options. This is a 2 part study: Part 1 will enrol at least 21 adult patients with any advanced cancer and Part 2 of the study will enrol approximately 10 adult patients with a specific advanced solid tumour or non-Hodgkin lymphoma at 2 research sites in the US and UK. All eligible patients will receive DS-3078a daily and will remain on study treatment as long as their cancer does not worsen, they have no severe side effects, and both the study doctor and sponsor agree the patient is receiving benefit and the patient is willing to continue. During scheduled visits patients will undergo a number of procedures to confirm safety and determine the effectiveness of the study drug, including vital signs, physical examination, blood and tissue sample collection for laboratory tests, ECG and scans to assess their tumour burden.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  12/LO/0583

• Date of REC Opinion

  25 Jun 2012

• REC opinion

  Further Information Favourable Opinion