RAMP 201

• Research type

  Research Study

• Full title

  A Phase 2 Study of VS-6766 (Dual RAF/MEK Inhibitor) Alone and In Combination with Defactinib (FAK Inhibitor) in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) (RAMP 201)

• IRAS ID

  1003662

• Contact name

  Andrew Koustenis

• Sponsor organisation

  Verastem, Inc.

• Eudract number

  2020-004264-26

• Clinicaltrials.gov Identifier

  NCT04625270

• Research summary

  Verastem, Inc. is sponsoring a research study that is testing the experimental drugs VS-6766 and defactinib, both a type of drug called a kinase inhibitor, for low grade serous ovarian cancer. Kinase inhibitors block cancer cell growth. Early clinical study data suggests that VS-6766, alone/in combination with defactinib, may control the growth of the cancer cells.

  The main aims of this clinical study are to:
  • Find out if the best course of treatment is to take either VS-6766 alone (monotherapy) or to take VS-6766 together (in combination) with defactinib.
  • Understand the safety of VS-6766 taken alone or taken together with defactinib.
  • Describe how well and how long the treatment with VS-6766 alone or in combination with defactinib works.
  • Measure the amount of VS-6766, defactinib and compounds related to the two study drugs in your blood at different times (this is called pharmacokinetics).

  This study is experimental which means that the use of VS-6766 alone and in combination with defactinib is not approved by any health authorities, except for use in research studies like this.

  This study will be conducted in two parts:
  • Part A will include participants with KRAS (a gene that instructs the cell to grow and take on specialised functions) mutated tumours. Mutated (changed) forms of the KRAS gene may cause cancer cells to grow and spread in the body.

  • Part B will include participants with and without KRAS mutated tumours.

  All participants will be randomised to one of two treatment groups or they could be manually assigned to a treatment group.

  The 2 treatment groups are:
  • Monotherapy: VS-6766 alone.
  • Combination Therapy: VS-6766 + Defactinib.

  This is a multicentre study, across approximately 44 study sites in the USA and Europe. A minimum of about 32 patients and a maximum of about 172 patients are expected to be enrolled.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  21/NW/0097

• Date of REC Opinion

  3 Jun 2021

• REC opinion

  Further Information Favourable Opinion