C31005 MLN0128 and MLN0128+MLN1117 Compared With Everolimus in mccRCC

• Research type

  Research Study

• Full title

  A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of Single-Agent MLN0128 and the Combination of MLN0128+MLN1117 Compared With Everolimus in the Treatment of Adult Patients With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma That Has Progressed on Vascular Endothelial Growth Factor-Targeted Therapy Protocol:C31005

• IRAS ID

  191697

• Contact name

  Thomas Powles

• Contact email

  thomas.powles@bartshealth.nhs.uk

• Sponsor organisation

  Millenium Pharmaceuticals Inc

• Eudract number

  2015-002133-22

• Clinicaltrials.gov Identifier

  126,347, IND Number

• Duration of Study in the UK

  3 years, 2 months, 16 days

• Research summary

  This phase 2, open-label, randomised, 3-arm study is designed to evaluate the effectiveness and safety of single-agent MLN0128 (experimental drug) and the combination of MLN0128 and MLN1117 (experimental drugs) compared with single-agent everolimus (approved drug) in the treatment of patients with metastatic clear-cell renal cell carcinoma (mccRCC) that has worsened either on or within 6 months of stopping Vascular Endothelial Growth Factor (VEGF)-targeted therapy.

  Participants who are able to enter the study will be separated according to previous treatments and risk category and then randomised (like a tossing a coin) at a ratio of 1:1:1 to one of 3 treatment groups:

  Arm A (63 participants): single-agent everolimus (oral tablet).
  Arm B (63 participants): single-agent MLN0128 (oral tablet).
  Arm C (63 participants): combination of MLN0128+MLN1117 (oral tablets).

  The treatment will be given in cycles that last for 28 days. The study consists of a screening visit (up to 28 days), Treatment period (up to 24 months), End of Treatment Follow Up 30-40 days later and Follow Up every 2-3 months.

  Approximately 189 participants will be recruited from approximately 60-70 sites in North America and Europe.

  Safety assessments (which include vital signs, hematology, serum chemistry and urinalysis) will be performed every 2 weeks for the first two 28-day cycles and then at the beginning of each subsequent cycle thereafter.

  Computed Tomography (CT scans), Magnetic Resonance Imaging (MRI scans), Bone scans and tumour biopsy may also be performed.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  16/LO/0582

• Date of REC Opinion

  23 May 2016

• REC opinion

  Further Information Favourable Opinion