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Investigating Safety, Tolerability and Efficacy of AZD5363 in Prostate Cancer.

NCT01692262 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2014-06-19

No results posted yet for this study

Summary

To investigate the safety, tolerability and anti-tumour activity of AZD5363, as monotherapy, in patients with metastatic Castrate-Resistant Prostate Cancer. AZD5363 will be investigated in patients who have progressed after chemotherapy (Part A) and in patients who have progressed before receiving chemotherapy (Part B).

Recruitment into Part A, Group 1 has been suspended. A new design for this group is currently being evaluated. Part A, group 2 patients (progressed after 1 or more 2nd generational anti-hormonal therapies) will receive AZD5363 480mg bid intermittently (4 days on/3days off).

Part B will only start if there is evidence of anti-tumour activity along with AZD5363 having an acceptable safety profile in Part A. Part B will be conducted in pre-chemotherapy patients on a dose and schedule selected from Part A.

Conditions

  • Metastatic Castrate-Resistant Prostate Cancer (mCRPC),
  • Efficacy,
  • Safety and Tolerability,
  • Pharmacokinetics,
  • Pharmacodynamics,
  • Tumour Response.

Interventions

DRUG

Intermittent dosing of AZD5363

Intermittent dosing of AZD5363: oral solid formulation, twice daily (480 mg bid 4 days on and 3 days off). Recruitment suspended and will not be re-opened.

DRUG

Intermittent dosing of AZD5363

Intermittent dosing of AZD5363: oral solid formulation, twice daily (480 mg bid 4 days on and 3 days off). Treatment to begin on Day 1 and to continue to study withdrawal. Recruitment complete.

DRUG

Intermittent dosing of AZD5363

Intermittent dosing of AZD5363: oral solid formulation, twice daily (480 mg bid 4 days on and 3 days off). Treatment to begin on Day 1 and to continue until study drug withdrawal. This part of the study will not be conducted.

Sponsors & Collaborators

Principal Investigators

  • Paul Stockman, MBCHB, PHD · AstraZeneca

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01692262 on ClinicalTrials.gov