Adavosertib Plus Chemotherapy in Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

95

Participants

Timeline

Start Date

January 30, 2015

Primary Completion Date

December 13, 2018

Study Completion Date

March 8, 2023

Conditions
Ovarian, Fallopian Tube, Peritoneal Cancer, P53 Mutation
Interventions
DRUG

Adavosertib

Adavosertib will be taken as oral capsules with water, approx. 2 hours before or 2 hours after food.

DRUG

Paclitaxel

"Paclitaxel will be administered as a 1-hour IV infusion (± 10 minutes) at a dose of 80 mg/m2 according to institutional standards on Days 1, 8, and 15 of each 28 Day cycle.~Patients should be pre-medicated with corticosteroids, diphenhydramine and/or H2 antagonists according to institutional standards."

DRUG

Carboplatin

Carboplatin, at a dose calculated to produce an AUC of 5 will be administered by intravenous infusion according to institutional standards on Day 1 of each 21 Day cycle. The carboplatin dose will be calculated using the Calvert Formula based on the patient's glomerular filtration rate (GFR) which is estimated by using the creatinine clearance.

DRUG

Gemcitabine

Gemcitabine 800 mg/m² will be administered IV on Days 1, 8, and 15 of each 28-Day cycle.

DRUG

PLD

PLD (pegylated liposomal doxorubicin) 40 mg/m² IV will be given on Day 1 of each 28-Day cycle.

Trial Locations (20)

10019

Research Site, New York

10065

Research Site, New York

19001

Research Site, Abington

30912

Research Site, Augusta

33401

Research Site, West Palm Beach

33612

Research Site, Tampa

37203

Research Site, Nashville

44195

Research Site, Cleveland

48201

Research Site, Detroit

53226

Research Site, Milwaukee

73104

Research Site, Oklahoma City

75390

Research Site, Dallas

85234

Research Site, Gilbert

85724

Research Site, Tucson

90024

Research Site, Los Angeles

92093

Research Site, La Jolla

94158

Research Site, San Francisco

02215

Research Site, Boston

M5G 2M9

Research Site, Toronto

1066 CX

Research Site, Amsterdam

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY

NCT02272790 - Adavosertib Plus Chemotherapy in Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer | Biotech Hunter | Biotech Hunter