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Dose Finding Study of BKM 120 in Combination With LH-RH Agonists and Bicalutamide in Men With Non Castrate Metastatic Prostate Cancer

NCT02487823 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2017-11-17

No results posted yet for this study

Summary

To determine the maximum-tolerated dose (MTD) of BKM120 when administered orally in combination with daily bicalutamide and LH-RH agonists to men with non castrate metastatic prostate cancer.

Conditions

  • Non Castrate Metastatic Prostate Cancer

Interventions

DRUG

BKM120 in combination with LH-RH agonists (suprefact) and bicalutamide

BKM 120, LH-RH agonists and Bicalutamide

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Institut Paoli-Calmettes

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • France

Study Locations

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Entities

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 NCT02487823 on ClinicalTrials.gov