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NCT02923947
Study to Assess Osimertinib in Patients w/ Adv Solid Tumours & Normal Kidney Function or Severe Kidney Impairment
Phase 1 trial testing Osimertinib; AZD9291 in Solid Tumours in 16 participants. Completed in 28 October 2022.
20 September 2018
Quick facts
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 4 May 2017 |
| Primary completion | 20 September 2018 |
| Estimated completion | 28 October 2022 |
| Sites | 11 locations across France, Spain, South Korea |
Drugs / interventions tested
- Osimertinib; AZD9291 — full drug profile →
Conditions studied
- Solid Tumours — all drugs for Solid Tumours →
Sponsor
AstraZeneca — full company profile →
Who can join
Adults 18 to 130, any sex, with Solid Tumours. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to assess the effect of severe renal impairment on the levels of AZD9291 in the blood in patients with advanced solid tumours compared to patients with normal renal function
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A multicenter, phase I, pharmacokinetic study of osimertinib in cancer patients with normal renal function or severe renal impairment.
Vishwanathan K, Sanchez-Simon I, Keam B, Penel N, et al · · 2020 · cited 9× · PMID 32567817 · DOI 10.1002/prp2.613
Verify or expand the search:
- PubMed search for NCT02923947
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Solid Tumours
Currently open trials in the same condition.
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- NCT07224425 — A Study in People With Advanced Cancer (Solid Tumours) to Test Different Doses of BI 3810944 and to Find Out Whether it · Phase 1 · recruiting
- NCT07165067 — A Study of AP601 in Patients With Locally Unresectable Advanced or Metastatic Solid Tumors · Phase 1 · recruiting
- NCT07403370 — Olanzapine Dose Comparison for the Prevention of HER-INV: A Network Meta-Analysis · recruiting
Other AstraZeneca trials
Trials by the same sponsor.
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- 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)
- Trial protocol + status: ClinicalTrials.gov NCT02923947 (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: 27 November 2023
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/NCT02923947.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing