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A Trial of Irinotecan and BKM120 in Previously Treated Advanced Colorectal Cancer

NCT01304602 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-01-06

No results posted yet for this study

Summary

This phase I trial will use the combination of irinotecan and BKM120 in patients with advanced colorectal cancer who have failed on or have become intolerant of at least one line of therapy for advanced colorectal cancer and who are candidates for irinotecan therapy.

Conditions

Interventions

DRUG

Irinotecan

IV over 90 minutes on day 1 of each cycle (every 2 weeks) at the cohort assigned dose level

DRUG

BKM120

BKM120, oral, daily starting with cycle 1/day 2 at the cohort defined dose level

Sponsors & Collaborators

  • University of Kansas Medical Center

    lead OTHER

Principal Investigators

  • Joaquina Baranda, MD · University of Kansas Medical 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
2011-02-28
Primary Completion
2014-04-30
Completion
2015-10-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01304602 on ClinicalTrials.gov