NCT01571024

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

A Phase I Study of BKM120 With mFOLFOX6 in Patients With Advanced Solid Tumors With Expansion Cohort in Metastatic Pancreatic Cancers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This single arm, multicenter, open-label Phase I clinical trial has been designed to establish the safety and tolerability of dose escalating BKM120 when combined with mFOLFOX6 and to define the MTD of BKM120 in this combination. Secondary objective will be to estimate the response rate, Progression Free Survival rate, and Overall Survival rate, after treatment with the Maximum Tolerated Dose of BKM120 in combination with mFOLFOX6 in patients with advanced solid tumors and metastatic pancreatic cancer. Eligible patients will be treated with BKM120 orally (PO), once per day (QD) in combination with mFOLFOX6 administered intravenously (IV) every 2 weeks on Days 1 and 15 of each cycle using a standard 3+3 dose escalation scheme. Each cycle will be repeated every 4 weeks (28 days). FOLFOX6 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. In the absence of treatment delays due to adverse events (AEs), treatment may continue until: disease progression, intercurrent illness that prevents further administration of treatment, unacceptable AE(s), patient decides to withdraw from the study, or general or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the investigator.

Conditions

• Advanced Solid Tumors
• Metastatic Colorectal Cancer
• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-05-01
• Completion: 2016-03-01
• First posted: 2012-04-04
• Last updated: 2017-04-26

Locations

1 site across 1 country: United States