West Cancer Center

ADVANCED SOLID TUMORS: Phase 1; TNBC and ovarian; aurora-kinase; "20080016"

A Phase 1, first-in-human study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered AMG 900 in adult subjects with advanced solid tumors

Title

Amgen 20080016

Study Title

A Phase 1, first-in-human study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered AMG 900 in adult subjects with advanced solid tumors

Site Link

NCT00858377

Malignancy

z- Advanced Solid tumors, Breast cancer, TNBC, ovarian

Stage

Stage 4

Disease Setting

Metastatic/palliative

Line Of Therapy

2nd line or later

Investigational Agent

AMG 900

Drug Class

Aurora kinase inhibitor

Daruka Mahadevan, MD, PhD

Sponsor

Amgen

Phase

Phase 1

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT00858377

Key Eligibility Criteria Details

Triple negative breast cancer or ovarian cancerTaxane-resistant (refractory to or progression within 6 moths)
Platinum resistant (ovarian cancer only)

ECOG<2
No active brain mets
No history of hematologic malignancy
No recent steroids
No systemic anticoagulation within 28 days

Objective

Primary- DLTs, PK profile, ORR; Seocondary- change in tumor volume, SUVmax

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

TNBC or ovarian CA

Dosing Frequency

AMG 900 given 4 days continuously every 2 weeks

Control Agents

N/A

Study Protocol

Randomized