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Protocol No. UW13043

Principal Investigator Wisinski, Kari

Phase I

Age Group Adult

Scope National

Sponsor Type Industry

Title A Phase I, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Anti-tumor Activity of AZD8186 in Patients with Advanced Castration resistant Prostate Cancer (CRPC), Squamous Non-Small Cell Lung Cancer (sqNSCLC), Triple Negative Breast Cancer (TNBC) and Patients with Known PTEN-deficient/mutated or PIK3CB mutated/amplified Advanced Solid Malignancies, as Monotherapy and in Combination with Abiraterone Acetate or AZD2014

Objective The purpose of the study is to investigate the safety and tolerability of AZD8186 in humans. This study will evaluate whether AZD8186 has any effect on tumor growth. This study will measure levels of AZD8186 in the blood and see how the body accepts AZD8186. We are interested in studying how AZD8186 is cleared by the body. If you agree, we will also take samples of your plasma, serum and tumor tissue to examine for possible cancer markers for example through DNA analysis.

Treatment This oral drug has not yet been approved by the regulatory agencies/Food and Drug Administration (FDA). The safety of the drug has not yet been tested in humans. The use of the drug in this study has been approved by the Independent Ethics Committee/Institutional Review Board.

Description This study will be conducted in 4 parts, part A ,B,C and D. Part A is a dose escalation of AZD8186 . In part A groups of patients will receive different doses and possibly schedules of AZD8186. In part B patients whose tumour type is missing the PTEN protein or changes such as gene mutation in PI3KCB), will receive a dose/schedule of AZD8186 (taken by mouth) selected using information from part A of the study. In part C groups of patients with mCRPC, will receive AZD8186 added to the approved dose and schedule of abiraterone acetate (and prednisone) treatment. In part D groups of patients will receive AZD8186 and AZD2014 (taken by mouth). In Part A or Part B some patients may be enrolled in a Food-Effect cohort. Your doctor will tell you if you will be joining a Food-Effect cohort. For some patients in this group, the first dose will be given under fasting conditions (water only; no food 2 hours before taking the dose until at least 1 hour after taking the dose), then the second dose will be given after a meal that will be provided. For other patients, this order will be reversed. You will only be able to participate in one part of the study, and you may not be able to choose which part. Your doctor will discuss which parts of the study you are eligible for. Click here for more info

Key Eligibility
  • Age 18 years and older
  • Proven diagnosis of prostate cancer, squamous non small cell lung cancer, triple negative breast cancer or a known PTEN-deficient solid malignancy that is refractory to standard therapies
  • Ineligible if treated with Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment
  • Ineligible if spinal cord compression or brain metastases present unless asymptomatic, treated and stable not requiring steroids for at least 4 weeks prior to start of study treatment
  • Ineligible if patient has received a previous allogeneic bone marrow transplant

Applicable Disease Sites Anal; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Hematologic cancers, other; Leukemia; Liver; Lung; Melanoma/Skin cancer; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid

Therapies Involved Cytotoxic Chemotherapy; Other

Drugs Involved AZD2014; AZD8186; abiraterone; prednisone

Status Open

Participating Institutions UW Hospital and Clinics