Clinical trial · Interventional
AZD8330 First Time in Man in Patients With Advanced Malignancies
A Phase I, Open-Label, Multi-centre Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of AZD8330 in Patients With Advanced Malignancies
NCT00454090CI-TRIAL-00005393completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary purpose of this protocol is to investigate the safety and tolerability of AZD8330 (ARRY-424704) in patients with Advanced Malignancies
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AZD8330 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- To assess safety and tolerability of AZD8330 in patient with advanced malignancies.
- measure
- Outcome variables: Adverse Events, Clinical Chemistry, Haematology, Urinalysis, Vital signs, MUGA scans/echocardiography, ECGs, Ophthalmologic examination, O2 saturation
Secondary outcomes (3)
- measure
- To determine the PK of AZD8330.
- measure
- To investigate possible PD/PK relationships
- measure
- To investigate effect of AZD8330 on pERK in PBMCs
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Cancer which is refractory to standard therapies, or no therapies exist; Exclusion Criteria: * Participated in radiotherapy, biological or chemotherapy within 21 days prior to study start; * Hasn't participated in investigation drug study within 30 days; * Brain metastases/spinal cord compression unless treated and stable, * Off steroids/anticonvulsants.
References
Publications (1)
- DERIVEDCohen RB, Aamdal S, Nyakas M, Cavallin M, Green D, Learoyd M, Smith I, Kurzrock R. A phase I dose-finding, safety and tolerability study of AZD8330 in patients with advanced malignancies. Eur J Cancer. 2013 May;49(7):1521-9. doi: 10.1016/j.ejca.2013.01.013. Epub 2013 Feb 21. PMID 23433846