NCT02117817

Phase I BKM120/Abraxane in Solid Tumors, Expansion Phase Recurrent Endometrial or Ovarian Cancer

A Phase I Trial of BKM120 in Combination With Weekly Nabpaclitaxel (Abraxane®) in Patients With Advanced Solid Tumors Followed by a Dose Expansion Phase in Patients With Recurrent Endometrial or Recurrent Ovarian Cancer

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the first part of this study or the dose escalation portion of the study is to determine what dose of BKM120 and Abraxane is safe to give when the two drugs are used at the same time in patients who are diagnosed with a solid cancer. A solid cancer is a cancer that does not involve the blood, bone marrow or lymph nodes. Dose escalation determines the least toxic and most effect dose of this drug combination for treatment. Once this dose is established, it will be used for the dose expansion phase of the study where we will determine the effect of BKM120 and Abraxane in women diagnosed with a recurrent endometrial or ovarian cancer. We will see whether the combination of both drugs improves the response and survival of patients treated on the two drug regimen. Also we will try to find out whether there are changes in tumors that can help us determine what patients are more likely to respond to BKM120 and Abraxane.

Detailed description

Primary Objectives: * To determine the safety and tolerability of BKM120 in combination with weekly nabpaclitaxel (Abraxane®) in patients with a recurrent solid tumor and in particular a recurrent endometrial or ovarian cancer. * To determine the MTD and DLT of BKM120 in combination with weekly nabpaclitaxel (Abraxane®) thereby establishing the recommended phase II dose. Secondary Objectives: * Obtain pilot data on the clinical tumor response utilizing RECIST criteria of BKM120 in combination with weekly nabpaclitaxel (Abraxane®) in patients with a history of recurrent endometrial or a recurrent ovarian cancer. * To determine the progression free survival (PFS) of patients treated with BKM120 and nabpaclitaxel (Abraxane®) and a history of recurrent endometrial or ovarian cancer. * To explore molecular markers that my serve as potential molecular predictors of response including PIK3CA, mTOR, KRAS, PTEN and p53 mutations as well as amplification of ErbB2. * To test the predictive value of PIK3CA and KRAS mutations in predicting response to this regimen in women diagnosed with a recurrent endometrial or ovarian cancer.

Conditions

• Ovarian Cancer
• Endometrial Cancer
• Recurrent Ovarian Cancer
• Recurrent Endometrial Cancer

Interventions

Type	Name	Description
DRUG	BKM120
DRUG	Nabpaclitaxel	Given IV

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-02-25
• Completion: 2015-02-25
• First posted: 2014-04-21
• Last updated: 2022-07-28