Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
NCT ID:
NCT01267266
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed prostate cancer with progressive disease; progressive disease may be defined as either
* New clinical or radiographic metastases
* Rising PSA: PSA must be greater than 1.0 ng/mL with at least 2 consecutive rises after completion of prior therapy; the PSA values documenting these rises should be separated by no less than 10 days; the baseline PSA value may be taken from the end of prior therapy
* Previous treatment with docetaxel for disease progression following hormonal therapy (i.e., castrate-resistant disease) required
* Treatment in the adjuvant or neoadjuvant setting will NOT be grounds for inclusion unless docetaxel has been used again in the setting of progressive CRPC
* ECOG performance status 0-1
* ANC ≥ 1,500/mm³
* Hemoglobin \> 9.0 g/dL
* Platelet count \> 100,000/mm³
* Total bilirubin \< 2.0 x institutional ULN
* AST/ALT \< 5 x institutional ULN in the presence of bone/liver metastases
* Serum creatinine (Cr) within ULN
* Patients with Cr \> ULN must have a Cr clearance of \> 60 mL/min
* Testosterone 50 ng/mL or lower if a patient is receiving an LHRH agonist
* No testosterone testing is required for men who have undergone surgical orchiectomy
* Fertile patients must agree to abstinence or some adequate form of contraception
* No patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs the ability to swallow AZD0530 tablets
* No history of uncontrolled or unstable cardiac dysrhythmia
* No resting ECG with measurable QTc interval of \> 480 msec at 2 or more time points within a 24-hour period
* No evidence of interstitial lung disease (bilateral, diffuse, parenchymal lung disease)
* A high-resolution CT of the chest will be required during screening
* No evidence of severe or uncontrolled systemic conditions (e.g., severe hepatic impairment) or current unstable or uncompensated respiratory or cardiac conditions which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol
* No patients with a known immunodeficiency syndrome
* No patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD0530
* No patients receiving any other investigational agents
* Previous AZD0530 exposure is allowed provided that the patient did not show radiographic progression during treatment
* Patients receiving non-steroidal anti-androgens (e.g., flutamide) or other hormonal treatment (such as ketoconazole, abiraterone, or TAK-700) must have stopped these drugs at least 28 days prior to enrollment for flutamide or ketoconazole, or at least 42 days prior to enrollment for bicalutamide or nilutamide, and the patients must have demonstrated progression of disease since the agents were suspended
* Patients should be at least 2 weeks away from previous chemotherapy, surgery, or radiotherapy
* No unresolved toxicity from previous treatments that are CTCAE grade 2 from previous anti-cancer therapy (except alopecia)
* Patients who are currently on zoledronic acid (Zometa) or other bisphosphonate therapy are eligible provided that they have been on therapy at least 6 weeks prior to participation
* Increases in bisphosphonate dosing will not be allowed (i.e., starting within 6 weeks or changing from every 3-month to every 1-month dosing)
* Use of specifically prohibited CYP3A4-active agents or substances are not permitted during protocol treatment, and patients who must continue treatment with these agents are not eligible
* Prohibited drugs should be discontinued 7 days prior to the administration of the first dose of AZD0530 and for 7 days following discontinuation of AZD0530 (unless otherwise specified)
* No concurrent use of non-FDA approved medications
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT01267266
Study Brief:
Protocol Section:
NCT01267266