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Modular Phase II Study to Link Targeted Therapy to Patients With Pathway Activated Tumors: Module 1 - BKM120 for Patients With PI3K-activated Tumors


Phase 2
18 Years
N/A
Open (Enrolling)
Both
PI3K Pathway Activated Tumors

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Trial Information

Modular Phase II Study to Link Targeted Therapy to Patients With Pathway Activated Tumors: Module 1 - BKM120 for Patients With PI3K-activated Tumors


Inclusion Criteria:



- Patient has a confirmed diagnosis of a solid tumor or hematological malignancy with
the exception of endometrial cancer, glioblastoma, nonsmall cell lung cancer,
prostate cancer or breast cancer.

- Patient's tumor has been evaluated and pre-identified to have activation of the PI3K
pathway, at a CLIA certified laboratory

- Patient must have received at least one prior treatment for metastatic and /or
locally advanced disease and for whom no standard therapy options are anticipated to
result in a durable remission.

- Patient must have measurable disease as per RECIST v1.1. or other appropriate
hematological guidelines

- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

Patient has received previous treatment with BKM120 Patient has symptomatic CNS metastases
Patient has mood disorder as outlined in Section 5 Patient has received chemotherapy or
targeted anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C)
prior to starting study drug.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of clinical benefit

Outcome Description:

Clinical benefit rate for patients with solid tumors will be assessed using RECIST 1.1 and will include responses of CR or PR or SD. For hematologic tumors other appropriate hematological response criteria will apply

Outcome Time Frame:

Week 16

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CBKM120ZUS40

NCT ID:

NCT01833169

Start Date:

March 2013

Completion Date:

February 2017

Related Keywords:

  • PI3K Pathway Activated Tumors
  • Solid tumor
  • malignancy
  • hematologi malignancy
  • PI3K pathway activation
  • BKM120

Name

Location

Tyler Cancer CenterTyler, Texas  75702