A Phase 1/2 Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VT-464 in Chemotherapy-Naïve Patients with Castration-Refractory Prostate Cancer
- Conditions
- Castration-refractory prostate cancer (CRPC)MedDRA version: 14.1Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-004103-20-GR
- Lead Sponsor
- Viamet Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 135
1. Patients must have documented histological or cytological evidence of adenocarcinoma of the prostate.
2. Patients must have a minimum serum PSA level of >2 ng/ml that is rising based on the Prostate Cancer Working Group 2 criteria.
3. Patients must be >18 years of age.
4. Patients must have castrate levels of testosterone (<50 ng/ml).
5. Patients must have undergone orchiectomy, or have been on LHRH agonists or antagonists, for at least 3 months prior to study entry. Patients on LHRH agonists/antagonists must remain on these agents for the duration of the study.
6. Patients must have an ECOG Performance Score of 0 or 1.
7. Patients must have adequate hematopoietic function as evidenced by:
- WBC >3,000/µl
- ANC >1,500/µl
- Platelet count >100,000/µl
- HGB >10 g/dl
8. Patients must have adequate hepatic function as evidenced by AST/ALT levels <3X the ULN and bilirubin levels of <2.0 mg/dl.
9. Patients must have adequate renal function as evidenced by a serum creatinine of <2.0 mg/dl
10. Patients must have K+ >3.5 mEq/l.
11. Patients or their legal representatives must be able to provide written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
1. Patients who have received prior cytotoxic chemotherapy for prostate cancer.
2. Patients who have received second-line antihormonal therapy, including ketoconazole, aminoglutethimide, or high-dose estrogen within 30 days of study entry.
3. Patients who have completed sipuleucel-T treatment within 30 days of study entry
4. Patients who have received abiraterone, TAK-700 (Orteronel), TOK-001, or MDV3100, or any other investigational product directed towards the androgen receptor or androgen biosynthesis.
5. Patients who have received antiandrogens such as flutamide (EULEXIN®), bicalutamide (CASODEX®), or nilutamide (NILANDRON®) for > 3 months must be off treatment for 6 weeks and demonstrate a continued rise in PSA after withdrawal. Patients on antiandrogens for < 3 months must be off medication for 2 weeks. Patients on 5 alpha reductase inhibitors such as finasteride (PROSCAR®, PROPECIA®), or dutasteride (AVODART®) must stop medication at least 3 months from study entry.
6. Patients who require pharmacological or replacement doses of systemic corticosteroids or who have received systemic corticosteroids within 30 days of study entry; use of topical, inhaled or ophthalmic steroids is permitted.
7. Patients who have received any investigational agent within 2 weeks of study entry.
8. Patients who have received radiotherapy to their primary prostate cancer within 6 weeks of study entry.
9. Patients with hepatic or other soft tissue visceral (other than pulmonary) or CNS metastases from prostate cancer.
10. Patients with a history of adrenal insufficiency.
11. Patients with a history within the last 3 years of another invasive malignancy.
12. Patients with a QTcF interval of >470 msec; if the Screening ECG QTc interval is >470 msec, itmay be repeated, and if repeat < 470 msec, the patient may be enrolled.
13. Patients who have started on bisphosphonates within 3 months of study entry
14. Patients with any intercurrent conditions that could preclude their participation in the study, pose an undue medical hazard, or which could interfere with the interpretation of the study results, including, but not limited to, congestive heart failure (NYHA Class III or IV), unstable angina, cardiac arrhythmia, recent (within the preceding 6 months) myocardial infarction, acute coronary syndrome or stroke, hypertension requiring more than 2 medications for adequate control, or diabetes mellitus with more than 2 episodes of ketoacidosis in the preceding 12 months.
15. Patients who have known active HIV, Hepatitis B, or Hepatitis C infections
16. Patients with any other medical, psychiatric, or social condition, including substance abuse, which in the opinion of the Investigator would preclude participation in the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method