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AZD8186 First Time In Patient Ascending Dose Study

NCT01884285 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2020-05-29

No results posted yet for this study

Summary

This is a phase I, open-label, multicentre study of AZD8186 administered orally in patients with advanced castrate-resistant prostate cancer (CRPC), squamous non-small cell lung cancer (sqNSCLC), triple negative breast cancer (TNBC) and known PTEN-deficient/mutated or PIK3CB mutated/amplified advanced solid malignancies as monotherapy and in combination with abiraterone acetate or AZD2014.

Conditions

  • Advanced Castrate-resistant Prostate Cancer CRPC
  • Squamous Non-Small Cell Lung Cancer sqNSCLC
  • Triple Negative Breast Cancer TNBC

Interventions

DRUG

Part A: AZD8186 monotherapy

The initial schedule will use intermittent dosing of AZD8186. Dose, frequency and schedule in subsequent cohorts may be modified in response to safety, tolerability, pharmacokinetic and preclinical data.

DRUG

Part B: AZD8186 monotherapy

Part B will be at a dose(s) and schedule(s) at or below from Part A

DRUG

Part C1: Abiraterone acetate combination with AZD8186

Dose and schedule finding of AZD8186 added to approved labelled dose of abiraterone acetate (with prednisone).

DRUG

Part D1: AZD2014 combination with AZD8186

Dose \& schedule finding of AZD8186 in combination with AZD2014

DRUG

Part D2 AZD2014 combination with AZD8186

Combination AZD8186/ AZD2014 dose expansion at dose determined in Part D1

DRUG

Part C2: Abiraterone acetate combination with AZD8186

Dose expansion of AZD8186 at dose determined in Part C1 added to approved dose of abiraterone acetate (with prednisone)

Sponsors & Collaborators

Principal Investigators

  • Michele Mochetta, MD · AstraZeneca

  • Lillian Siu, MD · Princess Margaret Hospital, Canada

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-09
Primary Completion
2019-03-31
Completion
2020-02-07

Countries

  • United States
  • Canada
  • Spain
  • United Kingdom

Study Locations

More Related Trials

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 NCT01884285 on ClinicalTrials.gov