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Prostate Cancer Clinical Trials

AZD8186 Ascending Dose Study
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
Status Conditions Phase Study ID
Recruiting Advanced Castrate-resistant Prostate Cancer (CRPC);
Squamous Non-Small Cell Lung Cancer (sqNSCLC);
Triple Negative Breast Cancer (TNBC)
Phase I NCT01884285
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 advanced solid malignancies. The study design allows an escalation of dose with intensive safety monitoring to ensure the safety of the patients.

There are two parts to this study: Part A, dose escalation, and Part B, expansion cohort(s) at the intended therapeutic dose(s).


Investigator
Celestia S. Higano, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • 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
Exclusions (conditions that would prevent participation in this study)
  • 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).
Last Updated
September 16, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.