NCT00454090CompletedPhase 1
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 83
- Locations
- 3
- Primary Endpoint
- To assess safety and tolerability of AZD8330 in patient with advanced malignancies.
Study Overview
Brief Summary
The primary purpose of this protocol is to investigate the safety and tolerability of AZD8330 (ARRY-424704) in patients with Advanced Malignancies
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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 Outcomes
- To determine the PK of AZD8330.
- To investigate possible PD/PK relationships
- To investigate effect of AZD8330 on pERK in PBMCs
Investigators
Study Sites (3)
Loading locations...
Similar Trials
Completed
Phase 1
Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3043HealthyNCT00984880AstraZeneca72
Withdrawn
Phase 1
Study to Assess Safety and Tolerability of AZD0530 in Combination With Carboplatin and PaclitaxelNon Small Cell Lung CancerCancerEpithelial Ovarian CancerNCT01000896AstraZeneca27
Completed
Phase 1
Open Label Prostate Cancer StudyProstate CancerNCT01162395AstraZeneca64
Completed
Phase 1
An Open Label Prostate Cancer Study in Japanese PatientsProstate CancerNCT01351688AstraZeneca13
Completed
Phase 1
Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD0328 in Elderly Healthy SubjectsAlzheimer's DiseaseNCT00687141AstraZeneca112