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A Multi-centre Study to Assess the Safety, Tolerability, and Pharmacokinetics of Capivasertib (AZD5363) in Combination With Novel Agents in Patients With Metastatic Prostate Cancer

2019-09-18 03:27:53 | BioPortfolio

Summary

This is a Phase Ib, open-label, multi-centre study to determine the safety, tolerability and pharmacokinetics (PK) of capivasertib when given in combination with novel agents (enzalutamide or abiraterone) to inform the selection of capivasertib dose regimens for each combination for further clinical evaluation when given to patients with metastatic castration resistant prostate cancer (CRPC). The study design allows an exploration of different doses with intensive safety monitoring to ensure the safety of the patients.

Description

The study will be conducted on multiple centers (≤10) in USA and Spain. The study design allows an exploration of different doses with intensive safety monitoring to ensure the safety of the patients.

The two planned combination treatments during Part A of this study are:

Part A1: Capivasertib and enzalutamide Part A2: Capivasertib and abiraterone Part B will include any optional dose expansion cohorts based on Safety Review Committee (SRC) review of data from Part A of this study.

The study will include up to approximately 87 evaluable patients, divided among the 4 study parts as follows:

Part A1: Up to approximately 36 patients (up to four dose levels with up to approximately 9 patients per dose level).

Part B1: Up to approximately 12 patients. Part A2: Up to approximately 27 patients (up to three dose levels with up to approximately 9 patients per dose level). Part B2: Up to approximately 12 patients.

Study Design

Conditions

Prostate Cancer

Intervention

Capivasertib, Enzalutamide, Abiraterone

Location

Research Site
Indianapolis
Indiana
United States
46202

Status

Recruiting

Source

AstraZeneca

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-18T03:27:53-0400

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Medical and Biotech [MESH] Definitions

An androstene derivative that inhibits STEROID 17-ALPHA-HYDROXYLASE and is used as an ANTINEOPLASTIC AGENT in the treatment of metastatic castration-resistant PROSTATE CANCER.

A glycoprotein that is a kallikrein-like serine proteinase and an esterase, produced by epithelial cells of both normal and malignant prostate tissue. It is an important marker for the diagnosis of prostate cancer.

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Proteins secreted by the prostate gland. The major secretory proteins from the human prostate gland include PROSTATE-SPECIFIC ANTIGEN, prostate-specific acid phosphatase, prostate-specific membrane antigen, and prostate-specific protein-94.

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Prostate cancer (cancer de prostata) Prostate cancer (cancer de prostata) is a form of cancer that develops in the prostate, a gland in the male reproductive system. Most prostate cancers are slow growing; however, there are cases of aggressive prostat...


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