Recent Updates
Recently added Catalysts

AZD3514

Phase 1

Prostate Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jan 12, 2016

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment77

FDA Designations

No designations recorded

Clinical trial landscape

AZD3514 · 2 trials · 1 indication

Phase 1 2
NCT01351688An Open Label Prostate Cancer Study in Japanese PatientsProstate Cancer
COMPLETED13 Analytics
NCT01162395Open Label Prostate Cancer StudyProstate Cancer
COMPLETED64 Analytics
PHASE1COMPLETED
An Open Label Prostate Cancer Study in Japanese Patients
Prostate CancerUnlock trial analytics
PHASE1COMPLETED
Open Label Prostate Cancer Study
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To investigate the safety and tolerability of AZD3514 when given orally to Japanese patients with castration resistant prostate cancer
All AEs will be collected throughout the study, from informed consent until 30 days after the end of study treatment. The total duration of this time frame can not be specified

Number of participants with adverse events

To investigate the safety and tolerability of AZD3514 when given orally to patients with CRPC.
At every visit.

Secondary Endpoints

To define the maximum tolerated dose, if possible, a lower biologically-effective dose(s) or maximum feasible dose of AZD3514
during the single dose period and the first 21 days of multiple dosing (ie, by study day 29)
To characterise the pharmacokinetics of AZD3514 after a single oral dose and at steady state after multiple oral doses
Multiple timepoints taken, begining at Day 1 and until 48 hrs after last dose. The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
To obtain an preliminary assessment of the anti-tumour activity of AZD3514
Every 12 weeks
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AZD3514EXPERIMENTALAscending doses of AZD3514 administered orally to patients to define the maximum tolerated dose (MTD)
AEXPERIMENTALAscending doses of AZD3514 administered orally to patients to define the maximum tolerated dose (MTD)

Interventions

NameTypeDescription
AZD3514DRUGPatients will be given AZD3514 tablets or capsules administered orally as a single dose, and then multiple once-daily dosing following a 7 day washout.
Unlock Study Design Details

Eligibility Criteria

Age Range20 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Males aged 20 years or older. * Histologically or Cytologically proven diagnosis of prostate cancer for which no standard therapy is currently considered appropriate * Documented evidence of metastatic prostate cancer * Serum testosterone concentration ≤50 ng/dL * World Health...

Countries:JapanUnited StatesNetherlandsUnited Kingdom
Unlock Eligibility Criteria

Competitive Landscape -Prostate Cancer 254 trials

Frequently asked questions about AZD3514

What is AZD3514 used for?

AZD3514 is an investigational small molecule being studied for the treatment of prostate cancer. It is in Phase 1 clinical development and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, one in the United States, Netherlands, and United Kingdom, and another in Japanese patients.

Who makes AZD3514?

AZD3514 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The drug is an investigational small molecule in Phase 1 clinical development for prostate cancer.

What phase is AZD3514 in?

AZD3514 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. Two Phase 1 trials have been completed, but the drug remains in early-stage clinical testing for prostate cancer.

What clinical trials is AZD3514 in?

AZD3514 has been studied in two completed Phase 1 clinical trials. The first, NCT01162395, was an open-label study in prostate cancer patients in the United States, Netherlands, and United Kingdom, enrolling 64 participants. The second, NCT01351688, was an open-label study in Japanese patients with prostate cancer, enrolling 13 participants.

Is AZD3514 FDA approved?

AZD3514 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for prostate cancer. The two clinical trials conducted so far have been completed, but the drug has not received marketing approval from the FDA or any other regulatory authority.