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AZD8186 First Time In Patient Ascending Dose Study

Status: Recruiting
Phase:
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01884285 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-300

 

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).

 

Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute

Overall PI:
Geoffrey Shapiro, MD, PhD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Andrew Wolanski, 617-632-6623, andrew_wolanski@dfci.harvard.edu

Eligibility Criteria

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).
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