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

NCT01862328 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-06-22

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Millennium Pharmaceuticals, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-10
Primary Completion
2018-05-21
Completion
2018-05-21

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT01862328 on ClinicalTrials.gov