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Study 10 and ARIEL2:

Studies Design

Relapsed ovarian cancer,

all comers

≥1 prior platinum-based

treatment

Platinum-sensitive

Study 10

CO-338-010

ARIEL2

CO-338-017

Part 1

Phase I

Dose escalation

Any solid tumour, including lymphoma

Part 2

Phase II

Part 3

Phase II/PK

Part 1

Phase II

Part 2

(Phase II extension)

Part 2A

Relapsed ovarian cancer

(g

BRCA

mut)

2–4 prior chemotherapy

treatments (last

treatment=platinum)

Platinum-sensitive

Part 2B

Relapsed ovarian cancer

(g

BRCA

mut or s

BRCA

mut)

3–4 prior chemotherapy

treatments

6-month treatment-free

interval after first regimen

Any platinum status

Relapsed high-grade

ovarian cancer

3–4 prior chemotherapies

Treatment-free interval

of >6 months following

first-line chemotherapy

Any platinum status

• Data from patients in Part 2A only are assessed in the EFFICACY analysis

• Data from patients in Parts 1, 2A and 3 are assessed in the SAFETY analysis

• Data from

mutBRCA population

receiving ≥2 prior lines of

chemotherapy are included in the EFFICACY analysis

• All enrolled patients receiving ≥1 dose of rucaparib are included in

the SAFETY analysis

Oza AM et al.

Gynecol Oncol

. 2017;147:267–275