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LDE225 and Paclitaxel in Solid Tumors

NCT01954355 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-12-06

No results posted yet for this study

Summary

The primary aim of this trial is to establish the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of LDE225 given in combination with standard doses of paclitaxel in patients with advanced solid tumors. In addition, the preliminary anti-tumor activity of this combination will be assessed, in particular in ovarian cancer.

Conditions

Interventions

DRUG

LDE225

400, 600 and 800 mg OD

DRUG

Paclitaxel

80 mg/m2 (days 1, 8, 15)

Sponsors & Collaborators

  • Swiss Cancer Institute

    lead OTHER

Principal Investigators

  • Anastasios Stathis, MD · IOSI, Ospedale San Giovanni

  • Cristiana Sessa, Prof Dr med · IOSI, Ospedale San Giovanni

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-10-31
Completion
2016-11-30

Countries

  • Switzerland

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 NCT01954355 on ClinicalTrials.gov