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Poster display session

3054 - A Multicentre Phase II Study of AZD1775 plus Chemotherapy in Patients with Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Date

09 Sep 2017

Session

Poster display session

Presenters

Kathleen Moore

Citation

Annals of Oncology (2017) 28 (suppl_5): v330-v354. 10.1093/annonc/mdx372

Authors

K.N. Moore1, K.A. Cadoo2, S. Chambers3, S. Ghamande4, G. Konecny5, A.M. Oza6, L. Chen7, P.A. Konstantinopoulos8, J. Lea9, D. Spitz10, D. Uyar11, G. Mugundu12, N. Laing12, D.K. Strickland13, S. Jones14, H. Burris15, D.R. Spigel16, E. Hamilton16

Author affiliations

  • 1 Department Of Obstetrics And Gynecology, University of Oklahoma Health Sciences Center, 73117 - Oklahoma City/US
  • 2 Medicine, Memorial Cloan Kettering Cancer Center, 10065 - New York/US
  • 3 Cancer Center, University of Arizona, 85719 - Tucson/US
  • 4 Georgia Cancer Center, Augusta University, 30912 - Augusta/US
  • 5 Oncology Hematology, UCLA Westwood, 90095 - Los Angeles/US
  • 6 Division Of Medical Oncology And Hematology, Princess Margaret Cancer Centre, M5G 1Z5 - Toronto/CA
  • 7 Gynecologic Oncology, University of California San Francisco, 94158 - San Francisco/US
  • 8 Gynecologic Oncology, Dana-Farber Cancer Institute, 02215 - Boston/US
  • 9 Obstetrics & Gynecology, University of Texas Southwestern, 75390 - Dallas/US
  • 10 Hematology & Oncology, Florida Cancer Specialists, 33401 - West Palm Beach/US
  • 11 Obstetrics & Gynecology, Medical College of Wisconsin, 53227 - Milwaukee/US
  • 12 Early Clinical Development, AstraZeneca Pharmaceuticals, 02451 - Waltham/US
  • 13 Medical And Clinical Science, Sarah Cannon Research Institute, 37203 - Nashville/US
  • 14 Strategic Development, Sarah Cannon Research Institute, 37203 - Nashville/US
  • 15 Clinical Operations, Sarah Cannon, 37203 - Nashville/US
  • 16 Medical Oncology, Sarah Cannon Research Institute/Tennessee Oncology, PLLC, 37203 - Nashville/US
More

Resources

Abstract 3054

Background

Ovarian cancers have a high rate of mutation in TP53, an alteration that produces a G1/S checkpoint deficiency and increases the level of endogenous DNA damage. This can lead to a dependency on WEE1, a multifunctional protein that can induce the G2/M checkpoint, promoting the repair of DNA damage before proceeding through mitosis and cell division. AZD1775 is a highly selective small-molecule inhibitor of WEE1 that showed promising antitumor activity in TP53m refractory/resistant ovarian cancer (OC) when combined with carboplatin (Leijen et al, JCO 2016). This Phase II study (GYN 49; D6010C00004; NCT02272790) is being conducted to further explore the safety, tolerability, and preliminary efficacy of AZD1775 when combined with 4 different chemotherapy regimens in patients (pts) with platinum resistant OC and fallopian and peritoneal cancers.

Trial design

This is an open-label four-arm study, with a primary endpoint of objective response rate. Study arms are:Table:

990TiP

ABCC2D
AZD1775175mg PO daily Days [D]1-2, 8-9, 15-16225mg PO BID x 5 doses D1-3, 8-10, 15-17225mg PO BID x 5 doses D1-3225mg PO BID x 5 doses D1-3, 8-10 (+ D15-17 if tolerated)175 or 225mg PO BID x 5 doses D1-3
Chemotherapygemcitabine 1000mg/m2 IV D1, 8, 15 q28Dpaclitaxel 80mg/m2 IV D1, 8, 15 q28Dcarboplatin AUC 5 IV D1 q21Dcarboplatin AUC 5 IV D1 q21Dpegylated liposomal doxorubicin [PLD] 40mg/m2 IV D1 q28D

Key eligibility criteria include platinum resistant OC or fallopian tube/primary peritoneal cancer (recurrence

Clinical trial identification

D6010C00004; NCT02272790

Legal entity responsible for the study

Sarah Cannon

Funding

AstraZeneca

Disclosure

K.N. Moore: Advisory roles with several pharmaceutical companies: Clovis, Amgen, AstraZeneca, Immunogen, Genentech/Roche, Merrimack, VSL. S. Ghamande: National PI for a phase 1 dose escalation trial with a HPV Listeria vaccine for cervix cancer sponsored by Advaxis. P.A. Konstantinopoulos: Advisor for Vertex and Merck. D. Spitz: Own stock in Gilead. D. Uyar: Research project funded by Merck. G. Mugundu: Employed by AstraZeneca; owns stock in AstraZeneca and Pfizer. N. Laing: Employed by AstraZeneca, own stock in AstraZeneca, intellectual property interests in AstraZeneca. All other authors have declared no conflicts of interest.

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