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BKM120 + mFOLFOX6 in Advanced Solid Tumors With Expansion Cohort Pancreatic Cancer

NCT01571024 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2017-04-26

No results posted yet for this study

Summary

The purpose of this study is to establish the safety and tolerability of BKM120 when combined with mFOLFOX6 and to define the maximum tolerated dose of BKM120 in this combination in advanced solid tumors including metastatic pancreatic cancer.

Conditions

Interventions

DRUG

BKM120

BKM120 40 mg, orally, once daily.

DRUG

mFOLFOX6

mFOLFOX6 treatment will be as follows: Oxaliplatin: 85 mg/m2 IV, Leucovorin: 400 mg/m2 IV, 5FU bolus: 400 mg/m2 IV and 5FU infusion: 2400 mg/m2 IV.

Sponsors & Collaborators

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Autumn McRee, MD · University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center; Chapel Hill, NC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-05-31
Completion
2016-03-31

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 NCT01571024 on ClinicalTrials.gov