NEO TRIAL A Phase II, Open-Label, Randomized, Multi-Centre Study, - - PowerPoint PPT Presentation

NEO TRIAL

A Phase II, Open-Label, Randomized, Multi-Centre Study, of Neoadjuvant Olaparib in Ovarian Cancer

NEO TRIAL SCHEMA

EVOLVE

A proof of concept, multi-centre, clinical trial of the combination cediranib-olaparib at the time of disease progression on PARP inhibitor in ovarian cancer

A proof of concept, multi-centre, clinical trial of the combination cediranib-

• laparib at the time of disease progression on PARP inhibitor in ovarian cancer

STUDY DESIGN

Previous therapy Olaparib >6 months Cediranib/Olaparib Orally daily

Proof of concept study

Progression

• n Olaparib

Olaparib/cediranib

Phase II Stage 1

Previous therapy PARP inhibitor

Progression

• n PARP

Phase II Stage 2

Standard Chemotherapy

Resistant cohort

Olaparib/cediranib Previous therapy PARP inhibitor

Progression

• n PARP

Standard Chemotherapy Placebo Olaparib

CR, PR SD Sensitive cohort After 4-6 cycles

STICs and STONES: OV.24

Prospective Assessment of Aspirin in Chemoprevention of High Risk Ovarian Cancer

Coordination: NCIC/CTG PIs: Drs. Oza, Lheureux, P. Shaw, E. Eisenhauer, H. Richardson, M Bernardini, D.

Tsoref

Funding: CCSRI for Canada

ANZGOG – Grant application Israel – Start up funds secured

International, multicentre, phase II, double-blind, placebo-controlled randomized trial comparing the effects of daily aspirin (<100mg or 300/325mg) versus placebo on the frequency of pre- and early-malignant lesions in resected RRSO specimens from women harboring germline BRCA1/2 mutations

• Window of Opportunity Trial
• 2:1 Randomization

STUDY DESIGN

• To define Impact of Aspirin on the Frequency of

Precursor Lesions at the time of RRSO

– Aspirin / Placebo – Standardization: SEE-FIM, upfront IHC analysis – Central Pathology review in the fallopian tube in resected specimens of patients who receive a minimum of 6 months of either low dose aspirin or placebo

• Occult carcinoma
• STIC

PRIMARY OBJECTIVE

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Feasibility: Estimated Accrual 200/year

Provinc ince Centre PI PI # # pt pt with prophylac phylactic ic salp lpingo ingo

• ophorect
• rectomy
• my

Eligi igible le subjects jects annua uall lly ALTA Cross Cancer Inst V Capstick 20 6 BC BCCA Vancouver D Miller 25 20 MB Cancer Care Manitoba: Winnipeg L Lotocki 10 5 NFLD D.H. Bliss Murphy Cancer Centtre P Power 15 10 ON Ottawa Hospital M Fung Kee Fung ON Jurvinski Cancer Centre ON PMH B Rosen 40 40 ON London Health Sciences Centre J McGee 20 10 QC CHUM Sauthier 12 8 QC CHUQ M Plante 20 most SASK Saskatoon C Giede 10 70%

Intergroups: ANZGOG, GINECO, MRC ?? NRG, NSGO

Current Status of Trial

• Protocol written
• Database specifications finalized
• Drug Supply: Discussions ongoing with regulatory

authority and drug manufacturer: stability testing and study supply capsule composition

• Planned trial activation in Canada: first quarter 2017
• Collaborating Groups must self fund for participation

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