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A Phase I, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD8186 in Patients With Advanced Castrate-resistant Prostate Cancer (CRPC), Squamous Non-Small Cell Lung Cancer (sqNSCLC), Triple Negative Breast Cancer (TNBC) and Patients With Known PTEN-deficient Advanced Solid Malignancies, With Expansion to Assess the Pharmacodynamic Activity of AZD8186 Within Prospectively-validated PTEN Deficient Tumours


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Castrate-resistant Prostate Cancer (CRPC);, Squamous Non-Small Cell Lung Cancer (sqNSCLC);, Triple Negative Breast Cancer (TNBC)

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Trial Information

A Phase I, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD8186 in Patients With Advanced Castrate-resistant Prostate Cancer (CRPC), Squamous Non-Small Cell Lung Cancer (sqNSCLC), Triple Negative Breast Cancer (TNBC) and Patients With Known PTEN-deficient Advanced Solid Malignancies, With Expansion to Assess the Pharmacodynamic Activity of AZD8186 Within Prospectively-validated PTEN Deficient Tumours


A Phase I, Open-label, Multicentre Study to Assess the Safety, Tolerability,
Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD8186 in
Patients with Advanced Castrate-resistant Prostate Cancer (CRPC), Squamous Non-Small Cell
Lung Cancer (sqNSCLC), Triple Negative Breast Cancer (TNBC) and patients with known
PTEN-deficient Advanced Solid Malignancies, with Expansion to Assess the Pharmacodynamic
Activity of AZD8186 within Prospectively-validated PTEN deficient Tumours


Inclusion Criteria:



- Provision of signed and dated, written informed consent prior to any study specific
procedures

- Male or female, aged 18 years and older

- Histologically or cytologically proven diagnosis of prostate cancer, squamous non
small cell lung cancer (sqNSCLC), triple negative breast cancer (TNBC), or a known
PTEN-deficient solid malignancy, that is refractory to standard therapies

- Females should be using adequate contraceptive measures (see Section 4.3), should not
be breast feeding and must have a negative pregnancy test prior to start of dosing if
of child-bearing potential

- World Health Organisation (WHO)/ECOG performance status 0 to 1 with no deterioration
over the previous 2 weeks and minimum life expectancy of 12 weeks

Exclusion Criteria:

- Treatment before study with (a) Nitrosourea or mitomycin C; (b) Investigational
agents from a previous clinical study; (c) Chemotherapy, immunotherapy or anticancer
agents; (d) hormonal therapy (e.g., steroids)

- Treatment before study with (a) Strong inhibitors and strong or moderate inducers of
CYP3A4 (b) Radiotherapy with a wide field of radiation

- With the exception of alopecia or toxicities related to the use of
gonadotropin-releasing hormone agonists any unresolved toxicities from prior therapy
greater than Common Terminology Criteria for Adverse Events grade 1 at the time of
study treatment

- Spinal cord compression or brain metastases unless asymptomatic, treated and stable
and not requiring steroids

- Any evidence of severe or uncontrolled systemic diseases including active liver
disease (other than malignancy), active bleeding diatheses, or active infection
including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Parts A and B: Safety and tolerability in terms of adverse events, serious adverse events (including death) and safety measures: ECG, physical examination, pulse, blood pressure, weight and laboratory variables

Outcome Time Frame:

Routine safety assessments, throughout the period that patients receive AZD8186 up to 30 days following discontinuation of last dose of study treatment.

Safety Issue:

Yes

Principal Investigator

Glen Clack

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

D4620C00001

NCT ID:

NCT01884285

Start Date:

June 2013

Completion Date:

March 2015

Related Keywords:

  • Advanced Castrate-resistant Prostate Cancer (CRPC);
  • Squamous Non-Small Cell Lung Cancer (sqNSCLC);
  • Triple Negative Breast Cancer (TNBC)
  • Advanced Castrate-resistant Prostate Cancer(CRPC)
  • Squamous Non-Small Cell Lung Cancer(sqNSCLC)
  • Triple Negative Breast Cancer(TNBC)
  • PTEN-deficient Advanced Solid Malignancies
  • Breast Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Prostatic Neoplasms

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