EUCTR2015-004764-10-GB进行中（未招募）1 期
A Phase 1/2 Open-label Study to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of Oral EPI-506 in Patients with Metastatic Castration-resistant Prostate Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 166
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Parts I and II
- •Inclusion Criteria
- •Patients are eligible for the study if all of the following apply:
- •1. Institutional Review Board (IRB)/Independent Ethics
- •Committee (IEC)-approved written informed consent and
- •privacy language as per national regulations must be
- •obtained from the patient prior to any study-related
- •procedures being performed.
- •2. Male 18 years of age or older.
- •3. Histologically confirmed adenocarcinoma of the prostate
- •without known neuroendocrine differentiation or small cell
- •4. PSA progression within 8 weeks of study treatment
- •(requires a baseline and minimum of 2 sequentially rising
- •PSA levels at an interval of = 1 week between each
- •determination while taking androgen deprivation therapy
- •5. Presence of metastatic disease at study entry documented
- •by 1 or more bone lesions on bone scan or by soft tissue
- •disease observed by CT/MRI.
- •6. Asymptomatic or minimally symptomatic patients defined
- •as reported pain score on BPI-SF question #3 (worst pain in
- •prior 24 hours) must be < 4 at screening.
- •7. Disease progression while receiving abiraterone or
- •enzalutamide as assessed by either:
- •a. PSA progression;
- •b. Radiographic progression with 2 new lesions on bone
- •scan or soft tissue progression on CT/MRI per
- •mRECISTv1.1.
- •8. The patient must have recovered from toxicities related to
- •any prior treatments, unless toxicities are assessed by the
- •Investigator as clinically non-significant (e.g., hot flashes
- •from luteinizing-hormone receptor hormone (LHRH)
- •9. Castrate at screening:
- •a. Ongoing ADT with LHRH agonist/antagonist therapy
- •or history of bilateral orchiectomy.
- •b. Serum testosterone = 1.7 nmol/L (50 ng/dL) at
- •10. Patients receiving bisphosphonates or other approved bonetargeting
- •therapy (e.g., denosumab) must be on a stable
- •dose for at least 4 weeks prior to the start of study drug.
- •11. PSA value at screening = 2 ng/mL.
- •12. Life expectancy of = 6 months according to the
- •Investigator’s judgment.
- •13. Eastern Cooperative Oncology Group (ECOG)
- •performance status score of 0 to 1.
- •14. All sexually active patients are required to use a condom as
- •well as meet 1 of the following:
- •a. Patient is non-fertile (orchiectomy), or has a female
- •partner of non-childbearing potential (i.e., postmenopausal,
- •surgically sterilized, hysterectomy)
- •b. Patient and his female partner use must agree to use
- •an adequate contraceptive method from the first day
- 另有 4 项未显示
排除标准
- •Parts I and II
- •Exclusion Criteria
- •Patients will be excluded from participation in the study if any
- •of the following apply:
- •1. Candidates for cytotoxic chemotherapy or have received a
- •biologic anti-cancer therapy (e.g., sipuleucel-T, docetaxel,
- •cabazitaxel, and estramustine) or a cytotoxic chemotherapy
- •within 4 weeks prior to the start of study drug.
- •2. Have received more than 1 line of chemotherapy for the
- •treatment of mCRPC.
- •3. Use of hormonal agents with anti-tumor activity against
- •prostate cancer including 5-alpha reductase inhibitors,
- •androgens (e.g., testosterone), cytoproterone acetate,
- •progestational agents, and estrogens/diethylstilbestrol
- •within 4 weeks prior to the start of study drug. Low-dose
- •hormonal agents (e.g., Megace) given for treatment of side
- •effects of LHRH therapy are allowed with prior approval
- •from the Medical Monitor.
- •4. Use of bicalutamide or nilutamide within 6 weeks prior to
- •the start of study drug, and flutamide within 4 weeks prior
- •to the start of study drug.
- •5. Use of an investigational agent that targets the AR axis (i.e.,
- •AR antagonists, AR signaling inhibitors, agents that target
- •alternative blockade of the AR, and androgen synthesis
- •inhibitory agents).
- •6. Enzalutamide and/or abiraterone use as follows:
- •a. Received more than 1 treatment course of
- •enzalutamide
- •b. Received more than 1 treatment course of abiraterone
- •c. Received either agent within 4 weeks prior to the start
- •of study drug.
- •Received abiraterone and/or enzalutamide and
- •discontinued agent without evidence of radiographic
- •or PSA progression.
- •7. Use of systemic corticost eroids exceeding prednisone 10 mg/day within 4 weeks prior to the start of study drug.
- •Increased dose of inhaled steroids may be allowed with
- •approval by a study Medical Monitor.
- •8. Use of prior radionuclide (e.g., strontium-89 or samarium).
- •9. Use of radium-223 dichloride within 28 days prior to the
- •start of study drug.
- •10. Received limited-field palliative bone radiotherapy
- •> 5 fractions and/or any radiotherapy within 2 weeks prior
- •to the start of study drug.
- •11. Received a blood transfusion within 28 days of screening.
- •12. Major surgery within 2 months prior to screening.
- •13. Known intra-cerebral disease or brain metastasis.
- •14. Spinal cord compression as follows:
- •a. Candidates with spinal cord compression related to
- •prostate cancer that required treatment within 6
- •months prior to starting study drug.
- 另有 4 项未显示
研究者
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