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Report for Clinical Trial NCT02117817

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT02117817 Ovarian Cancer Endometrial Cancer Recurrent Ovarian Cancer Recurrent Endometrial Cancer
MeSH:Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endometrial Neoplasms
HPO:Endometrial carcinoma Ovarian neoplasm

2 Interventions

Name: BKM120

Type: Drug
Group Labels: 1

Treatment (BKM120 in Combination with Weekly Nabpaclitaxel)

Name: Nabpaclitaxel

Description: Given IV
Type: Drug
Group Labels: 1

Treatment (BKM120 in Combination with Weekly Nabpaclitaxel)


Primary Outcomes

Measure: Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Time: 2 years

Secondary Outcomes

Measure: Response rate (at the end of the 3 months of therapy)

Time: 2 years

Measure: Time to progressive disease

Time: 2 years

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 P13K

- Ability to sign informed consent - INR ≤ 1.5 Exclusion Criteria: - Patients who have received prior treatment with a P13K inhibitor. --- P13K ---



HPO Nodes


HPO: