Trials Sponsors Conditions Drugs Pricing

Conditions

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

Keywords

Advanced Castrate-resistant Prostate Cancer(CRPC)Squamous Non-Small Cell Lung Cancer(sqNSCLC)Triple Negative Breast Cancer(TNBC)PTEN-deficient/mutated Advanced Solid MalignanciesPIK3CB mutated/amplified advanced solid malignancies

Outcome Measures

Primary Outcomes (1)

Safety and tolerability
Assess safety and tolerability of AZD8186 when given as monotherapy or in combination with abiraterone acetate (with prednisone) or with AZD2014 by measuring AEs, SAE (incl death), safety measures incl ECG, physical exam, pulse, blood pressure, weight, lab variables
Routine safety assessments, throughout the period that patients receive AZD8186 up to 30 days following discont of last dose of study treatment.

Secondary Outcomes (16)

Part A: The number of evaluable patients with dose limiting toxicities (DLTs).
DLTs assessed during the first 21 days of multiple dosing.
Part A, B, C + D: Antitumor activity of AZD8186 monotherapy or in combination
Every 12 weeks (non prostate patients) or every 6 weeks (prostate patients) from baseline up to disease progression or withdrawal of consent

Study Arms (6)

Part A: AZD8186 monotherapy

EXPERIMENTAL

Patients will receive a single dose on Day 1 followed by ongoing multiple dosing. The initial schedule will use intermittent dosing of AZD8186.

Drug: Part A: AZD8186 monotherapy

Part C2: AZD8186/abiraterone

EXPERIMENTAL

Patients will receive a week of abiraterone acetate with prednisone followed by combination dosing with AZD8186.

Drug: Part C2: Abiraterone acetate combination with AZD8186

Part D1: AZD8186 and AZD2014

EXPERIMENTAL

Combination dosing with AZD8186 and AZD2014 both given on an intermittent schedule at escalating dose levels of each IMP for combination dose finding

Interventions

Part A: AZD8186 monotherapyDrug

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.

Part A: AZD8186 monotherapy

Part B: AZD8186 monotherapyDrug

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

Part B: AZD8186 monotherapy

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Protocol design
Part A: AZD8186 monotherapy
The registry names a study arm, cohort or protocol phase. This describes the study design and does not establish a chemical identity, product equivalence or actual exposure.
Role as written:
Part A
Subject as written:
AZD8186 monotherapy
Registry study type: Interventional
View registry record
Protocol design
Part B: AZD8186 monotherapy
The registry names a study arm, cohort or protocol phase. This describes the study design and does not establish a chemical identity, product equivalence or actual exposure.
Role as written:
Part B
Subject as written:
AZD8186 monotherapy
Registry study type: Interventional
View registry record
Treatment programme
Part C1: Abiraterone acetate combination with AZD8186
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry record
Protocol design
Part D1: AZD2014 combination with AZD8186
The registry names a study arm, cohort or protocol phase. This describes the study design and does not establish a chemical identity, product equivalence or actual exposure.

Eligibility Criteria

Age18 Years - 130 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Provision of signed and dated, written informed consent prior to any study specific procedures
Male or female, aged 18 years and older

Sponsors & Collaborators

AstraZeneca
Industrylead

Study Sites (13)

Research Site

Boston, Massachusetts, 02215, United States

Research Site

Detroit, Michigan, 48201, United States

Research Site

New York, New York, 10065, United States

Research Site

Seattle, Washington, 98109, United States

Research Site

Madison, Wisconsin, 53792-5666, United States

Research Site

Toronto, Ontario, M5G 2M9, Canada

Research Site

Barcelona, 08035, Spain

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

AZD8186

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Michele Mochetta, MD
AstraZeneca
STUDY DIRECTOR
Lillian Siu, MD
Princess Margaret Hospital, Canada
PRINCIPAL INVESTIGATOR

Enrollment

147 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 17, 2013

First Posted

June 24, 2013

Study Start

July 9, 2013

Actual (reported)

AZD8186 First Time In Patient Ascending Dose Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (16)

Study Arms (6)

Part A: AZD8186 monotherapy

Part C2: AZD8186/abiraterone

Part D1: AZD8186 and AZD2014

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (13)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Part B: AZD8186 monotherapy

Part D2: AZD8186/ AZD2014

Part C1: AZD8186 & abiraterone

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (16)

Study Arms (6)

Part A: AZD8186 monotherapy

Part C2: AZD8186/abiraterone

Part D1: AZD8186 and AZD2014

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (13)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Part B: AZD8186 monotherapy

Part D2: AZD8186/ AZD2014

Part C1: AZD8186 & abiraterone

You may not qualify if:

Data Sharing

Source record

Locations