NCT00088790 is a Phase 1 clinical trial of AZD5438 in Neoplasms, sponsored by AstraZeneca.

Who is sponsoring NCT00088790?

NCT00088790 is sponsored by AstraZeneca.

What drugs are being tested in NCT00088790?

Interventions in NCT00088790: AZD5438.

Is NCT00088790 still recruiting?

NCT00088790 is currently completed. Last updated 25 January 2011.

Last reviewed 2011-01-25 · How we verify

NCT00088790

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase I Study to Assess the Safety and Tolerability of AZD5438 in Patients With Advanced Solid Malignancies

Completed Phase 1 Last updated 25 January 2011

What this trial tests

Phase 1 trial testing AZD5438 in Neoplasms. Completed in 1 December 2005.

Timeline

1 July 2004

Primary endpoint
1 December 2005

1 December 2005

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Primary purpose	treatment
Start date	1 July 2004
Primary completion	1 December 2005
Estimated completion	1 December 2005
Sites	2 locations across United States

Drugs / interventions tested

AZD5438 — full drug profile →

Conditions studied

Neoplasms — all drugs for Neoplasms →

Sponsor

AstraZeneca — full company profile →

Who can join

18 and older, any sex, with Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Purpose of this study is to assess the safety and tolerability of AZD5438 given orally to patients with advanced solid malignancies A review of the emerging clinical tolerability and exposure data from this study in conjunction with preclinical and the available clinical pharmacodynamic data relating to AZD5438, led to a decision by AstraZeneca that the development of AZD5438 as a potential anti-cancer agent would be discontinued.

Publications & conference data

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

Development of cell-cycle inhibitors for cancer therapy.
Dickson MA, Schwartz GK. · · 2009 · cited 169× · PMID 19370178 · DOI 10.3747/co.v16i2.428
Selective inhibition of CDK4/6: A safe and effective strategy for developing anticancer drugs.
Yuan K, Wang X, Dong H, Min W, et al · · 2021 · cited 103× · PMID 33532179 · DOI 10.1016/j.apsb.2020.05.001
Inhibitors of Cyclin-Dependent Kinases: Types and Their Mechanism of Action.
Łukasik P, Baranowska-Bosiacka I, Kulczycka K, Gutowska I. · · 2021 · cited 58× · PMID 33802080 · DOI 10.3390/ijms22062806
The Renaissance of Cyclin Dependent Kinase Inhibitors.
Ettl T, Schulz D, Bauer RJ. · · 2022 · cited 50× · PMID 35053461 · DOI 10.3390/cancers14020293
Cyclins and cyclin-dependent kinases: from biology to tumorigenesis and therapeutic opportunities.
Zabihi M, Lotfi R, Yousefi AM, Bashash D. · · 2023 · cited 37× · PMID 35781526 · DOI 10.1007/s00432-022-04135-6

Verify or expand the search:

Other recruiting trials for Neoplasms

Currently open trials in the same condition.

NCT07438782 — First Time in Human (FTIH) Study to Investigate the Safety and Preliminary Activity of GSK5533524 Alone or in Combinatio · Phase 1 · recruiting
NCT07382817 — Phase 1 Study of JV-394 Autologous Anti-CD94 CAR T for r/r CD94+ T/NK Cell Neoplasms · Phase 1 · recruiting
NCT07277270 — A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tum · Phase 1 · recruiting
NCT07257640 — IL-5 CAR-T Cell Therapy for Refractory/Relapsed Eosinophilic Leukemia · Phase 1 · recruiting
NCT07213609 — A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer · Phase 1, PHASE2 · recruiting

Other AstraZeneca trials

Trials by the same sponsor.

NCT06998095 — Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea · not yet recruiting
NCT07431775 — Saphnelo Use in Females of Child-bearing Potential · not yet recruiting
NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis · NA · not yet recruiting
NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec · Phase 4 · not yet recruiting
NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00088790 (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 AstraZeneca
Last refreshed: 25 January 2011

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/NCT00088790.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing