Open Label Prostate Cancer Study

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Prostate Cancer

Treatments

Drug: AZD3514

Study type

Interventional

Funder types

Industry

Identifiers

NCT01162395

IND 111707

D3760C00001

2010-020232-19 (EudraCT Number)

Details and patient eligibility

About

The main purpose of the study is to investigate the safety and tolerability of AZD3514 when given orally to patients with castration-resistant prostate cancer (CRPC)

Enrollment

64 patients

Sex

Male

Ages

20 to 130 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Males aged 20 years or older.
Histologically or Cytologically proven diagnosis of prostate cancer for which no standard therapy is currently considered appropriate.
Documented evidence of metastatic prostate cancer
Presence of progressive disease defined as one or more:
Biochemical progression of the prostate cancer
Progression as defined by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 guidelines
Two or more new metastatic bone lesions from bone scans from a previous assessment
Serum testosterone concentration less or equals 50 ng/dL
World Health Organization (WHO) performance status 0 to 1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks.
Sexually active males should be willing to use condoms
For inclusion in the AZD3514 administered in combination with abiraterone acetate cohort(s), patients must:
Have received prior chemotherapy containing or based on docetaxel
Not have received prior treatment with abiraterone acetate, MDV3100, TAK700, TOK001 or other similar therapies which target the AR axis or with selective AR down-regulator-like properties
For inclusion in the AZD3514 administered in combination with abiraterone acetate in patients who are currently receiving abiraterone acetate cohort(s), patients must:
1. Have been stable on abiraterone acetate abiraterone acetate for ≥ 4 months (i.e. stable PSA values) and have achieved ≥ 50% reduction in PSA while being treated with abiraterone acetate
2. Have evidence of biochemical progression (PSA) of the prostate cancer, as defined in inclusion number 5 (except for the withdrawal of abiraterone acetate as an anti-androgen therapy)
For inclusion in the paired (same lesion) tumour biopsy research, patients must:
1. Provide informed consent for paired tumour biopsy sampling
2. Have bone or soft tissue lesions that are suitable for paired biopsy sampling

Exclusion criteria

Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAEv4) grade 1 except for alopecia or toxicities related to the use of gonadotropin-releasing hormone agonists
Medically important spinal cord compression or brain metastases
Medically important evidence of severe or uncontrolled systemic disease
History of hypersensitivity to active or inactive excipients of AZD3514 or drugs with a similar chemical structure or class to AZD3514
Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD3514
Inadequate bone marrow reserve or organ function
Any medically important factors identified from electrocardiogram (ECG) measurements
Concurrent or recent treatment with certain medications or medical procedures

The following criteria exclude patients from entering the AZD3514 administered in combination with abiraterone acetate cohort(s):

As judged by the investigator, any evidence of severe or uncontrolled systemic diseases or conditions, including adrenocortical insufficiency or a history of cardiovascular disease including heart failure (currently there are no randomized data for the use of abiraterone acetate in patients with LVEF < 50% or NYHA Class III or IV heart failure), which would make it undesirable for the patient to participate in the trial. See the full local prescribing information for abiraterone acetate for more detail
Child-Pugh class B and C hepatic impairment
If unable to fast for ≥ 2 hours prior to taking a dose to ≥ 1 hour post dose
Received abiraterone acetate treatment previously
Known hypersensitivity to components of prednisone or prednisolone
Any systemic fungal infections