Trials / Completed
CompletedNCT01570296
A Trial of Gefitinib in Combination With BKM120 in Patients With Advanced Non-Small Cell Lung Cancer, With Enrichment for Patients Whose Tumours Harbour Molecular Alterations of PI3K Pathway and Known to Overexpress EGFR
A Phase Ib Trial of Gefitinib (EGFR Tyrosine Kinase Inhibitor, Iressa™) in Combination With BKM120, an Oral Pan-class I PI3K Inhibitor in Patients With Advanced Non-Small Cell Lung Cancer, With Enrichment for Patients Whose Tumours Harbour Molecular Alterations of PI3K Pathway and Known to Overexpress EGFR
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- National Cancer Centre, Singapore · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The safety, tolerability and recommended phase 2 dose (RP2D) of the combination of gefitinib and BKM120 will be determined.
Detailed description
2.1 Primary • The safety, tolerability and recommended phase 2 dose (RP2D) of the combination of gefitinib and BKM120 will be determined. 2.2 Secondary * The pharmacokinetic (PK) profile of gefitinib in combination with BKM120 will be determined. * The preliminary anti-tumor activity of gefitinib in combination with BKM120 will be determined. * The pharmacodynamic target modulation effects using a hair follicle assay will be determined. 2.3 Exploratory * The role of circulating tumour cells as assessed by a microfluidic device will be analyzed and the genetic alterations implicated in lung cancer, including but not limited to EGFR mutations, PI3KCA mutations, PTEN loss will be characterized. * The feasibility of detecting somatic mutations from plasma DNA will be ascertained.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gefitinib and BKM120 | Dose escalation study of gefitinib and BKM120 with expansion cohort |
Timeline
- Start date
- 2011-10-03
- Primary completion
- 2016-02-22
- Completion
- 2018-12-17
- First posted
- 2012-04-04
- Last updated
- 2023-03-29
Locations
1 site across 1 country: Singapore
Source: ClinicalTrials.gov record NCT01570296. Inclusion in this directory is not an endorsement.