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LDE225 + Everolimus in Advanced Gastroesophageal Adenocarcinoma

NCT02138929 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-06-11

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest tolerable dose of LDE225 that can be given in combination with everolimus to patients with esophageal or GEJ cancer. The safety of the drug combination will also be studied.

Conditions

  • Esophageal Cancer

Interventions

DRUG

Everolimus

Induction and Dose Expansion Phase: 10 mg by mouth daily in a 28 day cycle.

DRUG

LDE 225

Induction Phase Starting Dose: 400 mg by mouth daily in a 28 day cycle. Expansion Phase Starting Dose: Maximum tolerated dose from Induction Phase.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Jaffer Ajani, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-10
Primary Completion
2020-06-08
Completion
2020-06-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT02138929 on ClinicalTrials.gov