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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00454090

Enrollment

Registered

2007-03-29

Start date

2007-03-31

Completion date

2011-03-31

Last updated

2011-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Advanced Malignancies

Brief summary

The primary purpose of this protocol is to investigate the safety and tolerability of AZD8330 (ARRY-424704) in patients with Advanced Malignancies

Interventions

DRUGAZD8330

oral tablet

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
To assess safety and tolerability of AZD8330 in patient with advanced malignancies.	—
Outcome variables: Adverse Events, Clinical Chemistry, Haematology, Urinalysis, Vital signs, MUGA scans/echocardiography, ECGs, Ophthalmologic examination, O2 saturation	—

Secondary

Measure	Time frame
To determine the PK of AZD8330.	—
To investigate possible PD/PK relationships	—
To investigate effect of AZD8330 on pERK in PBMCs	—

Countries

Norway, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026