West Cancer Center

SARCOMA: Metastatic; Soft-tissue; Any line; \"ANNOUNCE\"

A randomized, double-blind, placebo-controlled, phase 3 trial of doxorubicin plus olaratumab versus doxorubicin plus placebo in patients with advanced or metastatic soft tissue sarcoma

Title

Eli Lilly I5B-MC-JGBJ

Study Title

A randomized, double-blind, placebo-controlled, phase 3 trial of doxorubicin plus olaratumab versus doxorubicin plus placebo in patients with advanced or metastatic soft tissue sarcoma

Site Link

study/NCT02451943

Malignancy

Sarcoma, soft-tissue sarcoma

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

Any

Investigational Agent

Olaratumab (LY3012207)

Drug Class

PDGFR-alpha antibody

David Portnoy, MD

Sponsor

Eli Lilly and Company

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

study/NCT02451943

Key Eligibility Criteria Details

Advanced unresectable or metastatic soft tissue sarcoma
Not amenable to cure with surgery or radiation
ECOG PS 0-1
No prior treatment with anthracyclines (doxorubicin, idarubicin, etc.)
Any number of prior lines of therapy. Therapy must have stopped at least 28 days before randomization
Available tumor tissue (FFPE)
LVEF >50%
No GIST or Kaposi's sarcoma
No prior whole pelvis or mediastinal radiation

Objective

Primary- OS: Secondary- PFS, ORR, Disease control, Symptom burden, QOL, DOR, PK

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

No GIST or Kaposi\'s sarcoma

Dosing Frequency

Olaratumab 20mg/kg IV on day 1 and 8 of cycle 1, 15mg/kg day 1 and day 8 thereafter, of 21 day cycle. Doxorubicin as below

Control Agents

Placebo + doxorubicin 75mg/m2 IV on day 1 of each 21 day cycle x8 cycles

Study Protocol

Randomized