NCT02482311

Safety, Tolerance, PK, and Anti-tumour Activity of AZD1775 Monotherapy in Patients With Advanced Solid Tumours

Completed Phase 1 Last updated 3 July 2023

What this trial tests

Phase 1 trial testing AZD 1775 in Ovarian Cancer, TNBC, SCLC, Other Solid Tumours in 92 participants. Completed in 22 August 2019.

Timeline

1 July 2015

Primary endpoint
25 January 2018

22 August 2019

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	92
Start date	1 July 2015
Primary completion	25 January 2018
Estimated completion	22 August 2019
Sites	16 locations across Canada, United States

Drugs / interventions tested

• AZD 1775 — full drug profile →

Conditions studied

• Ovarian Cancer, TNBC, SCLC, Other Solid Tumours — all drugs for Ovarian Cancer, TNBC, SCLC, Other Solid Tumours →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 99, any sex, with Ovarian Cancer, TNBC, SCLC, Other Solid Tumours. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-label, multi-centre, Phase Ib study of AZD1775 designed to assess the safety, tolerability, pharmacokinetics, and anti-tumour activity of AZD1775 monotherapy in patients with advanced solid tumours.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent advances in therapeutic strategies for triple-negative breast cancer.
   Li Y, Zhang H, Merkher Y, Chen L, et al · · 2022 · cited 643× · PMID 36038913 · DOI 10.1186/s13045-022-01341-0
2. A WEE1 family business: regulation of mitosis, cancer progression, and therapeutic target.
   Ghelli Luserna di Rorà A, Cerchione C, Martinelli G, Simonetti G. · · 2020 · cited 232× · PMID 32958072 · DOI 10.1186/s13045-020-00959-2
3. Triple-Negative Breast Cancer: Current Understanding and Future Therapeutic Breakthrough Targeting Cancer Stemness.
   Lee KL, Kuo YC, Ho YS, Huang YH. · · 2019 · cited 164× · PMID 31505803 · DOI 10.3390/cancers11091334
4. Triple-negative breast cancer and the potential for targeted therapy.
   Jhan JR, Andrechek ER. · · 2017 · cited 155× · PMID 29095114 · DOI 10.2217/pgs-2017-0117
5. Targeting AXL and mTOR Pathway Overcomes Primary and Acquired Resistance to WEE1 Inhibition in Small-Cell Lung Cancer.
   Sen T, Tong P, Diao L, Li L, et al · · 2017 · cited 112× · PMID 28698200 · DOI 10.1158/1078-0432.ccr-17-1284
6. Targeting DNA damage repair in small cell lung cancer and the biomarker landscape.
   Sen T, Gay CM, Byers LA. · · 2018 · cited 95× · PMID 29535912 · DOI 10.21037/tlcr.2018.02.03
7. Cell cycle checkpoints and beyond: Exploiting the ATR/CHK1/WEE1 pathway for the treatment of PARP inhibitor-resistant cancer.
   Gupta N, Huang TT, Horibata S, Lee JM. · · 2022 · cited 89× · PMID 35259479 · DOI 10.1016/j.phrs.2022.106162
8. Signal pathways and precision therapy of small-cell lung cancer.
   Yuan M, Zhao Y, Arkenau HT, Lao T, et al · · 2022 · cited 72× · PMID 35705538 · DOI 10.1038/s41392-022-01013-y