West Cancer Center

MOLECULARLY TARGETED: PIK3CA mutations: \\\"PMT4979g\\\"

An open-label, phase I/II, dose-escalation study evaluating the safety and tolerability of GDC-0032 in patients with locally advanced or metastatic solid tumors or non-Hodgkin's lymphoma and in combination with endorcrine therapy in patients with locally advaned or metastatic hormone receptor-positive breast cancer.

Title

Hoffman-La Roche GO00886

Study Title

Site Link

NCT01296555

Malignancy

Bladder, Head and Neck, Gastric, TNBC, Ovarian

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

> or = 2nd line

Investigational Agent

taselisib (GDC-0032)

Drug Class

PI3 kinase delta inhibitor

Ari VanderWalde, MD

Sponsor

Hoffman-La Roche

Phase

Phase 1

Status

Closed to Accrual

Key Eligibility Criteria

NCT01296555

Key Eligibility Criteria Details

Advanced solid malignancies with PIK3CA mutations (see "malignancies" tab for current eligible disease states)
No untreated or active CNS mets
No diabetes requiring active treatment
No active CHF or ventricular arryhtmias requiring treatment
Measurable disease via RECIST 1.1
ECOG PS 0-1
No O2 requirements
No XRT within previous 2 weeks (for bony mets) or 4 weeks for all other reasons
No requirements for immunosuppression

Objective

Primary- DLTs, AUC, Cmax; Secondary- BOR, DoR, PFS, OS

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

PIK3CA mutation

Dosing Frequency

PO daily

Control Agents

N/A

Study Protocol

Randomized