C28002- Adult Patients With Advanced Nonhematologic Malignancies

• Research type

  Research Study

• Full title

  A Multiarm, Open-label, Phase 1b Study of MLN2480 (an Oral A-, B-, and CRAF Inhibitor) in Combination With MLN0128 (an Oral mTORC 1/2 Inhibitor), or Alisertib (an Oral Aurora A Kinase Inhibitor), or Paclitaxel, in Adult Patients With Advanced Nonhematologic Malignancies

• IRAS ID

  169741

• Contact name

  Mark Middleton

• Contact email

  mark.middleton@oncology.ox.ac.uk

• Sponsor organisation

  Millennium Pharmaceuticals, Inc., a Takeda Oncology Company

• Eudract number

  2014-003340-12

• Duration of Study in the UK

  2 years, 10 months, 29 days

• Research summary

  The drug being tested in this study is called MLN2480. MLN2480 is being tested to evaluate side effects and determine the maximum tolerated dose (MTD) and recommended dose for future studies when administered in combination with one of three other medications. This study will assess the safety of MLN2480 as well as how it is processed by the body in participants with solid nonhematologic malignancies (a cancer tumour) who have failed standard therapies.

  The study will be conducted in two phases, the Dose Escalation Phase and the Dose Expansion Phase. Approximately 55 participants will be enrolled in the Escalation Phase. Participants in this phase will be assigned to one of the three treatment groups:

  • MLN2480 100 mg + MLN0128
  • MLN2480 100 mg + alisertib
  • MLN2480 100 mg + paclitaxel

  Once the MTD for each combination treatment arm has been established in the Escalation Phase, one or more of the combination treatments will be selected for the Expansion Phase. Approximately 48 additional participants will be enrolled in the Expansion Phase.

  Patients enrolled into the Escalation phase are not eligible to participate in the Expansion phase.

  This multi-centre trial will be conducted worldwide. The overall time to participate in this study for patients is up to 12 months with the option to continue. Participants will make approximately 20 visits to the clinic including an end of study visit 30 days after last dose of study drug for a follow-up assessment.
  

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  15/SC/0046

• Date of REC Opinion

  16 Mar 2015

• REC opinion

  Further Information Favourable Opinion