A Study of Sapanisertib, Combination of Sapanisertib With MLN1117, Paclitaxel and Combination of Sapanisertib With Paclitaxel in Women With Endometrial Cancer

NCT02725268 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2021-11-24

Study results available
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Summary

The primary purpose of this study is to determine if sapanisertib in combination with weekly paclitaxel improves progression-free survival (PFS) compared to weekly paclitaxel alone.

Conditions

  • Endometrial Neoplasms

Interventions

DRUG

Paclitaxel

Paclitaxel intravenous solution.

DRUG

Sapanisertib

Sapanisertib capsules.

DRUG

MLN1117

MLN1117 capsules.

Sponsors & Collaborators

  • European Network of Translational Research in Ovarian Cancer - EUTROC

    collaborator UNKNOWN
  • European Network of Individualized Treatment in Endometrial Cancer - ENITEC

    collaborator OTHER_GOV
  • Millennium Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director Clinical Science · Millennium Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-01
Primary Completion
2019-07-02
Completion
2020-10-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Germany
  • Italy
  • Netherlands
  • Norway
  • Spain
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02725268 on ClinicalTrials.gov