C31004-A Phase 2, Randomised Study in Advanced Endometrial Cancer
Research type
Research Study
Full title
A Phase 2, Randomized Study of MLN0128 (a Dual TORC1/2 Inhibitor), MLN0128+MLN1117 (a PI3Kα Inhibitor), Weekly Paclitaxel, or the Combination of Weekly Paclitaxel and MLN0128 in Women With Advanced, Recurrent, or Persistent Endometrial Cancer.
IRAS ID
194313
Contact name
Hae Suk Suh
Contact email
Sponsor organisation
Millennium Pharmaceuticals Inc
Eudract number
2014-005394-37
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
This is a phase 2, open-label, randomised, multicenter, 4-arm study of the safety and effectiveness of MLN0128 (experimental drug)in combination with paclitaxel (approved drug), single-agent MLN0128, single-agent paclitaxel, and MLN0128 in combination with MLN1117 (experimental drug) in adult women with advanced, recurrent or persistent endometrial cancer.
Approximately 260 patients will be randomised at a ratio of 1:1:1:1 to receive study drug in 1 of 4 treatment arms:
-Arm A:(65 participants) paclitaxel (intra-venous infusion).
-Arm B:(65 participants) paclitaxel(intra-venous infusion)+ MLN0128 (oral tablet).
-Arm C:(65 participants) MLN0128 (oral tablet).
-Arm D:(65 participants) MLN0128 + MLN1117 (oral tablets).Patients who discontinue study treatment for reasons other than progressive disease will continue to have progression free survival (PFS) follow-up visits every 2 months for the first 6 months after the end-of-treatment (EOT) visit, then every 3 months until disease progression. After disease progression, patients will be followed for overall survival (OS) every 3 months. Patients will attend the end of trial (EOT) visit 30 to 40 days after receiving their last dose of study drug.
The following assessments will be performed: physical examination, vital signs (BP, heart rate and temperature),Electrocardiogram (ECG), Computed Tomography (CT scan) or Magnetic Resonance Imaging (MRI scan), blood and urine sampling, questionnaires, home glucose monitoring and tumour biopsy.
REC name
London - City & East Research Ethics Committee
REC reference
16/LO/0581
Date of REC Opinion
23 May 2016
REC opinion
Further Information Favourable Opinion