West Cancer Center

MOLECULARLY TARGETED: Metastatic: >/=2nd line; P2P: "SIGNATURE CBKM120ZUS40"

Molecular phase II study to link targeted therapy to patients with pathway activated tumors: Module 1 - BKM120 for patients with PI3K-activated tumors

Title

Novartis CBKM120ZUS40

Study Title

Molecular phase II study to link targeted therapy to patients with pathway activated tumors: Module 1 - BKM120 for patients with PI3K-activated tumors

Site Link

NCT01833169

Malignancy

y- Advanced Cancer; Head and Neck (SCCHN), Non-Hodgkin Lymphoma (NHL), Ovarian, Bladder (Urothelial), Cervical, Liposarcoma, Adenoid Cystic

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

>/=2nd line

Investigational Agent

BKM120

Drug Class

PI3K inihibitor

Lee Schwartzberg, MD

Sponsor

Novartis Pharmaceuticals

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT01833169

Key Eligibility Criteria Details

One (or more) of following abnormalities:
PI3K mutation, deletion, or amplification
PTEN mutation
Loss of function of PI3KR1
None of the following malignancies:
CRC, NSCLC, breast, prostate, endometrial, GMB
At least one prior line of therapy
No standard options anticipated to provide benefit
ECOG 0-1
No CNS mets
No significant mood disorder

Objective

Primary- Clinical Benefit Rate: Secondary- ORR, PFS, DOR, OS, Safety

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

PI3K activation (PI3K mutation, PTEN mutation, loss of PTEN, PI3K amplification, or loss-of-function mutation of PI3KR1)

Dosing Frequency

BKM120 100mg oral qday

Control Agents

N/A

Study Protocol

Randomized