CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 64 enrolled
Drug / intervention
MLN4924 +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01862328
NCT01862328Phase 1Completed
CompareCT.gov

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

Millennium Pharmaceuticals, Inc.·interventional·Posted May 24, 2013·Updated Jun 22, 2020

In Brief

A Phase 1 clinical trial evaluating MLN4924, Paclitaxel, and 3 other interventions for Solid Tumors. Completed, enrolled 64 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumors
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 24, 2013
Enrollment StartJun 10, 2013
Primary CompletionMay 21, 2018
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 13.1 years ago

Interventions

MLN4924drug

MLN4924 (intravenously \[IV\]) in participants in a 21-day cycle: * MLN4924 on Days 1,3,5 of each cycle

Paclitaxeldrug

Paclitaxel (IV) in a 21-day cycle: * Paclitaxel on Day 1 of each cycle

Gemcitabinedrug

Gemcitabine (IV) in participants in a 28-day cycle: -Gemcitabine on Days 1,8,15 of each cycle

Docetaxeldrug

Docetaxel (IV) in participants in a 21-day cycle: \- Docetaxel on Day 1 of each cycle

Carboplatindrug

Carboplatin (IV) in participants in a 21-day cycle: \- Carboplatin on Day 1 of each cycle