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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 AZD3514 in Patients With Metastatic Castration-Resistant Prostate Cancer.


Phase 1
20 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD3514 in Patients With Metastatic Castration-Resistant Prostate Cancer.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To investigate the safety and tolerability of AZD3514 when given orally to patients with CRPC.

Outcome Time Frame:

At every visit.

Safety Issue:

Yes

Principal Investigator

Tony Elliott, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Christie Hospital

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

D3760C00001

NCT ID:

NCT01162395

Start Date:

August 2010

Completion Date:

December 2013

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Tumour
  • Castration Resistant
  • Prostate Androgen Receptor Down Regulator
  • Metastatic
  • Prostatic Neoplasms

Name

Location

Research SiteBend, Oregon