Trials / Unknown
UnknownNCT01527877
Study of BKM120 in Advanced Squamous Cell Carcinoma of Head and Neck
An Open Label, Single Arm, Multicenter Phase II Study of BKM120 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck Who Failed to Respond to Platinum-based Therapy
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 53 (estimated)
- Sponsor
- Yonsei University · Academic / Other
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This study is to evaluate disease control rate (DCR) at 8 weeks of BKM120 administered as therapy for patient with recurrent/metastatic head and neck squamous cell carcinoma.
Detailed description
One promising approach to the treatment of cancer is inhibition or modulating the crucial signal transduction pathway of PI3K-Akt-mTOR. Several PI3K inhibitors are being tested in the clinical trials for cancer treatment but not for the head and neck cancer yet. BKM120 is a specific Pan-class I PI3K inhibitor. We suggest multicenter single arm phase II study to determine anti-tumor effects of BKM120 in patients with recurrent and/or metastatic SCCHN who failed to prior platinum-based chemotherapy regimens.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BKM120 | Patients will be instructed to take BKM120 orally at a dose of 100 mg with a glass of water once daily, in a fasting state or with a light fat-free meal, and as close as possible to the same time each day. The patient will be dosed on a flat scale of mg/day and not be adjusted to body weight or body surface area. If vomiting occurs no attempt should be made to replace the dose. • BKM120 should be taken 1-hour following a light meal. Please note that patients must avoid consumption of Seville orange (and juice), grapefruit or grapefruit juice, grapefruit hybrids, pummelos and exotic citrus fruits from 7 days prior to the first dose of study drug and during the entire study treatment period due to potential CYP3A4 interaction. Regular orange juice is allowed. |
Timeline
- Start date
- 2012-09-01
- Primary completion
- 2013-12-01
- Completion
- 2014-08-01
- First posted
- 2012-02-07
- Last updated
- 2012-10-08
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01527877. Inclusion in this directory is not an endorsement.