Phase I Open Label Dose Escalation Study to Investigate the Safety & Pharmacokinetics of AZD5312 in Patients With Androgen Receptor Tumors
Completed · Phase 1
Conditions studied: Advanced Solid Tumours With Androgen Receptor Pathway as a Potential Factor
In brief
This is a first time in man (FTIM), Phase I study to determine the Maximum Tolerated Dose, Recommended Phase 2 Dose, safety, tolerability and Pharmacokinetics of AZD5312. This is a multicentre study with sites in the United States and United Kingdom. Approximately 90 patients are expected to be enrolled in this study. The study involves two parts, Part A, Dose Escalation and Part B, Dose Expansion.
Key facts
- Study ID
- NCT02144051
- Run by
- AstraZeneca
- People needed
- 32
- Starts
- 2014-05-01
- Expected to finish
- 2016-03-01
- Last updated by the study team
- 2016-07-14
Who can join
Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Patients who have been treated with most recent chemotherapy or investigational drugs ≤21 days or 5 half-lives (whichever is longer) for enrolment, and/or who have National Cancer Institute (NCI) Common Terminology Criteria of Adverse Events (CTCAE) v4.03 Grade 1 treatment-related side effect, with the exceptions of alopecia, should not be enrolled. For further details, please refer to the following link: http://evs.nci.nih.gov/ftp1/CTCAE/About.html.
- Patients who received chemotherapy regimens given either continuously or weekly with limited potential for delayed toxicity or palliative/focal radiotherapy within the last 2 weeks or any other radiotherapy or immunotherapy within 3 weeks of the first dose of study treatment.
- Major surgery (excluding placement of vascular access) ≤21 days of beginning of the study drug or minor surgical procedures ≤7 days. No waiting required following port-a-cath placement.
- Any of the following cardiac criteria: - Congestive heart failure (CHF) per New York Heart Association (NYHA) classification > Class II (see Appendix C) - Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy - Unstable angina or new-onset angina - QTcF >470 ms on screening electrocardiogram (ECG) by Fredericia's formula.
- Patients with leptomeningeal metastases
- Previously untreated brain metastases. Patients who have received radiation or surgery for brain metastases are eligible if therapy was completed at least 3 weeks previously and there is no evidence of central nervous system disease progression, mild neurologic symptoms, and no requirement for chronic corticosteroid therapy.
- As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
- Concurrent conditions that in investigator's opinion would jeopardize compliance with protocol.
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with protocol.
Where it is running
- Research Site — Sarasota, Florida, United States
- Research Site — Nashville, Tennessee, United States
- Research Site — Milwaukee, Wisconsin, United States
- Research Site — London, United Kingdom
Full record on ClinicalTrials.gov
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