NCT02610075

Phase Ib Study to Determine MTD of AZD1775 Monotherapy in Patients With Locally Advanced or Metastatic Solid Tumours.

Completed Phase 1 Last updated 3 July 2023

What this trial tests

Phase 1 trial testing AZD1775 in Locally Advanced Solid Tumours in 62 participants. Completed in 26 April 2018.

Timeline

1 December 2015

Primary endpoint
26 April 2018

26 April 2018

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	62
Start date	1 December 2015
Primary completion	26 April 2018
Estimated completion	26 April 2018
Sites	3 locations across United States

Drugs / interventions tested

• AZD1775 — full drug profile →

Conditions studied

• Locally Advanced Solid Tumours — all drugs for Locally Advanced Solid Tumours →
• Metastatic Solid Tumours — all drugs for Metastatic Solid Tumours →
• Ovarian Cancer — all drugs for Ovarian Cancer →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 130, any sex, with Locally Advanced Solid Tumours or Metastatic Solid Tumours. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This Phase Ib study will identify the Maximum Tolerated Dose (MTD) of AZD1775 monotherapy when administered orally once daily (QD) or two times per day (BID) on Days 1 to 5 followed by 9 days of rest in 14-day cycles, or QD on a 5/2 dosing schedule (5 days on, followed by 2 days rest) in 21-day cycles in patients with locally advanced or metastatic solid tumours. Alternative treatment schedules may be explored if preliminary data suggest these would be more appropriate.

The effect of food on single dose PK of AZD1775 will be assessed in 12 patients. In this sub-study, patients will receive a single oral dose of AZD1775 with 240 mL of water, once in the fasted state and once following a high-fat meal.

Publications & conference data

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

1. 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
2. Treatment of <i>NRAS</i>-mutated advanced or metastatic melanoma: rationale, current trials and evidence to date.
   Boespflug A, Caramel J, Dalle S, Thomas L. · · 2017 · cited 44× · PMID 28717400 · DOI 10.1177/1758834017708160
3. Harnessing DNA Replication Stress for Novel Cancer Therapy.
   Zhu H, Swami U, Preet R, Zhang J. · · 2020 · cited 30× · PMID 32854236 · DOI 10.3390/genes11090990
4. A Phase Ib Study Assessing the Safety, Tolerability, and Efficacy of the First-in-Class Wee1 Inhibitor Adavosertib (AZD1775) as Monotherapy in Patients with Advanced Solid Tumors.
   Bauer TM, Moore KN, Rader JS, Simpkins F, et al · · 2023 · cited 25× · PMID 37278879 · DOI 10.1007/s11523-023-00965-7
5. Exploiting DNA Damage Repair in Precision Cancer Therapy: BRCA1 as a Prime Therapeutic Target.
   Raimundo L, Calheiros J, Saraiva L. · · 2021 · cited 23× · PMID 34298653 · DOI 10.3390/cancers13143438
6. A phase Ib study of adavosertib, a selective Wee1 inhibitor, in patients with locally advanced or metastatic solid tumors.
   Falchook GS, Sachdev J, Imedio ER, Kumar S, et al · · 2023 · cited 20× · PMID 37171722 · DOI 10.1007/s10637-023-01371-6
7. Synthetic Lethal Targeting of Mitotic Checkpoints in HPV-Negative Head and Neck Cancer.
   Deneka AY, Einarson MB, Bennett J, Nikonova AS, et al · · 2020 · cited 20× · PMID 32012873 · DOI 10.3390/cancers12020306
8. Synthetic and Medicinal Chemistry Approaches Toward WEE1 Kinase Inhibitors and Its Degraders.
   Alli VJ, Yadav P, Suresh V, Jadav SS. · · 2023 · cited 18× · PMID 37323408 · DOI 10.1021/acsomega.3c01558