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MLN1117 in Combination With Docetaxel, Paclitaxel, and Other Investigational Anticancer Agents to Treat Participants With Gastric and Gastroesophageal Adenocarcinoma

NCT02551055 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-09-20

Study results available
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Summary

The purpose of this study is to evaluate the maximum tolerated dose (MTD) or recommended Part 2 dose, safety and efficacy of MLN1117 (TAK-117) in combination with docetaxel, paclitaxel, investigational TAK-659 or investigational alisertib in adult participants with advanced and metastatic gastric or gastroesophageal adenocarcinoma. The study consists of a dose escalation phase (Part 1) and a dose expansion phase (Part 2).

Conditions

  • Advanced and Metastatic Gastric or Gastroesophageal Adenocarcinoma

Interventions

DRUG

MLN1117

MLN1117 Tablets

DRUG

TAK-659

TAK-659 Tablets

DRUG

Alisertib

Alisertib Tablets

DRUG

Paclitaxel

Paclitaxel intravenous infusion

DRUG

Docetaxel

Docetaxel intravenous infusion

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-15
Primary Completion
2017-02-17
Completion
2017-02-17
FDA Drug
Yes

Countries

  • United States
  • Spain

Study Locations

More Related Trials

Entities

Drugs

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 NCT02551055 on ClinicalTrials.gov