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NCT02585973
Dose-escalating AZD1775 + Concurrent Radiation + Cisplatin for Intermediate/High Risk HNSCC
Phase 1 trial testing AZD1775 in Carcinoma, Squamous Cell of Head and Neck in 12 participants. Completed in 23 June 2021.
14 June 2019
Quick facts
| Lead sponsor | UNC Lineberger Comprehensive Cancer Center |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 26 October 2015 |
| Primary completion | 14 June 2019 |
| Estimated completion | 23 June 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- AZD1775 — full drug profile →
- Cisplatin (cisplatin) — full drug profile →
- Intensity Modulated Radiotherapy Treatments
Conditions studied
- Carcinoma, Squamous Cell of Head and Neck — all drugs for Carcinoma, Squamous Cell of Head and Neck →
Sponsor
UNC Lineberger Comprehensive Cancer Center — full company profile →
Who can join
18 and older, any sex, with Carcinoma, Squamous Cell of Head and Neck. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This open label, single-arm, Phase 1b study is designed to identify the maximum tolerated dose (MTD) using a traditional 3+3 dose escalation design of the WEE-1 inhibitor AZD1775 when added to standard of care chemotherapy (cisplatin) and radiation for the treatment of locally advanced squamous cell cancer of the head and neck (HNSCC).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
State-of-the-art strategies for targeting the DNA damage response in cancer.
Pilié PG, Tang C, Mills GB, Yap TA. · · 2019 · cited 876× · PMID 30356138 · DOI 10.1038/s41571-018-0114-z -
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 -
Radiotherapy as a tool to elicit clinically actionable signalling pathways in cancer.
Petroni G, Cantley LC, Santambrogio L, Formenti SC, et al · · 2022 · cited 154× · PMID 34819622 · DOI 10.1038/s41571-021-00579-w -
Targeting the DNA Damage Response in OSCC with TP53 Mutations.
Lindemann A, Takahashi H, Patel AA, Osman AA, et al · · 2018 · cited 117× · PMID 29489434 · DOI 10.1177/0022034518759068 -
Leveraging the replication stress response to optimize cancer therapy.
Cybulla E, Vindigni A. · · 2023 · cited 109× · PMID 36323800 · DOI 10.1038/s41568-022-00518-6 -
Altering DNA Repair to Improve Radiation Therapy: Specific and Multiple Pathway Targeting.
Biau J, Chautard E, Verrelle P, Dutreix M. · · 2019 · cited 91× · PMID 31649878 · DOI 10.3389/fonc.2019.01009 -
Combination Platinum-based and DNA Damage Response-targeting Cancer Therapy: Evolution and Future Directions.
Basourakos SP, Li L, Aparicio AM, Corn PG, et al · · 2017 · cited 91× · PMID 27978798 · DOI 10.2174/0929867323666161214114948 -
Targeting the DNA Damage Response for Cancer Therapy by Inhibiting the Kinase Wee1.
Bukhari AB, Chan GK, Gamper AM. · · 2022 · cited 50× · PMID 35251998 · DOI 10.3389/fonc.2022.828684
Verify or expand the search:
- PubMed search for NCT02585973
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of AZD1775
Trials testing the same drug.
- NCT03668340 — AZD1775 in Women With Recurrent or Persistent Uterine Serous Carcinoma or Uterine Carcinosarcoma · Phase 2 · active not recruiting
- NCT03028766 — WEE1 Inhibitor with Cisplatin and Radiotherapy: a Trial in Head and Neck Cancer · Phase 1 · completed
- NCT03012477 — CISPLATIN + AZD-1775 In Breast Cancer · Phase 2 · completed
- NCT02546661 — Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer · Phase 1 · active not recruiting
- NCT02688907 — Phase II, Single-arm Study of AZD1775 Monotherapy in Relapsed Small Cell Lung Cancer Patients With MYC Family Amplificat · Phase 2 · terminated
Other recruiting trials for Carcinoma, Squamous Cell of Head and Neck
Currently open trials in the same condition.
- NCT07090499 — A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors · Phase 1 · recruiting
- NCT03485209 — Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors · Phase 2 · active not recruiting
Other UNC Lineberger Comprehensive Cancer Center trials
Trials by the same sponsor.
- NCT06656936 — The PharmFIT Study · NA · not yet recruiting
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- NCT07069595 — PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease · Phase 2 · recruiting
- NCT04266730 — Trial of a Personalized and Adaptive Neoantigen Dose-Adjusted Vaccine Concurrently With Pembrolizumab · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02585973 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center
- Last refreshed: 29 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02585973.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing