NCT01862328

Dose Escalation, Multi-arm Study of MLN4924 Plus Docetaxel, Gemcitabine, or Combination of Carboplatin and Paclitaxel in Participants With Solid Tumors

A Phase 1b, Open-Label, Dose Escalation, Multi-arm Study of MLN4924 Plus Docetaxel, Gemcitabine, or Combination of Carboplatin and Paclitaxel in Patients With Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to establish the maximum tolerated dose (MTD) and assess the safety and tolerability of MLN4924 (pevonedistat) in combination with docetaxel, paclitaxel and carboplatin, and gemcitabine in participants with solid tumors.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	MLN4924	MLN4924 (intravenously \[IV\]) in participants in a 21-day cycle: * MLN4924 on Days 1,3,5 of each cycle
DRUG	Paclitaxel	Paclitaxel (IV) in a 21-day cycle: * Paclitaxel on Day 1 of each cycle
DRUG	Gemcitabine	Gemcitabine (IV) in participants in a 28-day cycle: -Gemcitabine on Days 1,8,15 of each cycle
DRUG	Docetaxel	Docetaxel (IV) in participants in a 21-day cycle: \- Docetaxel on Day 1 of each cycle
DRUG	Carboplatin	Carboplatin (IV) in participants in a 21-day cycle: \- Carboplatin on Day 1 of each cycle

Timeline

• Start date: 2013-06-10
• Primary completion: 2018-05-21
• Completion: 2018-05-21
• First posted: 2013-05-24
• Last updated: 2020-06-22
• Results posted: 2020-06-22

Locations

6 sites across 1 country: United States