EUCTR2015-001012-35-BG进行中（未招募）1 期
A Phase 2 Open Label, Multi-Center, Multinational, Randomized, Parallel Design Study Investigating The Efficacy and Safety Of GTx-024 On Metastatic or Locally Advanced ER+/AR+ Breast Cancer (BC) in Postmenopausal Women - N/A
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- GTx, Inc.
- 入组人数
- 88
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
- 性别
- Female
入选标准
- •Adult postmenopausal women with metastatic or recurrent locally advanced ER+/AR+ BC.
- •Subject Subjects eligible for inclusion in this study must meet all of the following criteria:
- •1. Adult women (= 18 years of age) with metastatic orrecurrent locally advanced BC, not amenable to curative treatment by surgery or radiotherapy, with objective
- •evidence of disease progression.
- •? Women must have received = 1 prior hormonal treatment(s) in the metastatic or adjuvant setting.
- •? - If the most recent hormonal treatment was in the metastatic setting, duration of response (tumor regression or stabilization of disease) to this specific course of therapy must be = 6 months
- •?- If the most recent hormonal treatment was in the adjuvant setting, duration of response (disease free) to this specific course of therapy must be = 3 years
- •2. Histological or cytological confirmation of ER+ BC as assessed by a local laboratory using slides, paraffin blocks, or paraffin sample or by medical history: ER+ (confirmed as ER expression more than or equal to 1%
- •positive tumor nuclei)
- •3. Human epidermal growth factor receptor 2 (HER2)-negative tumor by local laboratory testing (immunohistochemistry [IHC] 0, 1+ regardless of fluorescence in situ hybridization [FISH] ratio; IHC 2+ with FISH ratio lower than 2.0 or HER2 gene copy less than 6.0; FISH ratio of 0, indicating gene deletion, when positive and negative in situ hybridization [ISH] controls are present)
- •4. Availability of paraffin embedded or formalin fixed tumor tissue; OR, a minimum of 10 and up to 20 slides of archived tumor tissue for central laboratory confirmation of AR status and molecular subtyping. Metastatic tumor
- •tissue is preferred when possible
- •5. Postmenopausal women. Postmenopausal status is defined by the National Comprehensive Cancer Network as either:
- •?- Age = 55 years and one year or more of amenorrhea
- •?- Age < 55 years and one year or more of amenorrhea, with an estradiol assay < 20 pg/mL
- •- Age < 55 years and surgical menopause with bilateral oophorectomy
- •a. Note: Ovarian radiation or treatment with a luteinizing hormone-releasing hormone (LH-RH) agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression at the time of screening. Long term use (> 6 months prior to screening) is permitted.
- •6. Radiological or clinical evidence (bone scan, computerized tomography [CT], and magnetic resonance Imaging [MRI]) of recurrence or progression within
- •30 days before randomization
- •7. Subject must have either measurable disease or bone-only non-measurable disease, evaluable according to RECIST 1.1
- •8. Adequate organ function as shown by:
- •?- Absolute neutrophil count (ANC) = 1,000 cells/mm3
- •?- Platelet count = 100,000 cells/mm3
- •?- Hemoglobin (Hgb) = 9.0 g/dL
- •?- Serum aspartate aminotransferase (AST) and alanine transaminase (ALT) = 2.5 upper limit of the normal range (ULN) (or = 5 if hepatic metastases are present)
- •?- Total serum bilirubin = 2.0 × ULN (unless the subject has documented Gilbert Syndrome)
- •?- Alkaline phosphatase levels = 2.5 × ULN (= 5 × ULN in subjects with liver metastasis)
- •? - Serum creatinine = 2.0 mg/dL or 177 µmol/L
- •? - International normalized ratio (INR) or activated partial thromboplastin (aPTT) < 1.5 × ULN (unless on anticoagulant treatment at screening)
- •9. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status 4 0 or 1
- •10. Subjects with bone metastases should be tre
排除标准
- •Subjects eligible for this study must not meet any of the following criteria:
- •1. Previously received > 1 course of chemotherapy (not including immunotherapies or targeted therapies) for the treatment of metastatic BC
- •a. Note: Subjects may have received 1 course of chemotherapy prior to surgery for the treatment of locally advanced disease and 1 course of chemotherapy for the treatment of metastatic BC; however, if surgery could not be performed, this
- •will count as the 1 chemotherapy course allowed prior to study
- •2. Known hypersensitivity to any of the GTx-024 components or subjects previously received treatment with Selective Androgen Receptor Modulator (SARM)
- •3. Subjects with radiographic evidence of central nervous system (CNS) metastases as assessed by CT or MRI that are not well-controlled (symptomatic or requiring control with continuous corticosteroid therapy [e.g.,dexamethasone])
- •a. Note: Subjects with CNS metastases are permitted to participate in the study if the CNS metastases are medically well-controlled and stable for at least 28 days after receiving local therapy (irradiation, surgery, etc.)
- •4. Radiotherapy within 14 days prior to randomization except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture, which can then be completed within 7 days prior to randomization. Subjects must have recovered from radiotherapy toxicities prior to randomization
- •5. Currently receiving hormone replacement therapy, unless discontinued prior to screening
- •6. Subjects positive for Human Immunodeficiency Virus (HIV)
- •7. Subject has a concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases subject risk, in the opinion of the Investigator, such as but not limited to:
- •- Myocardial infarction or arterial thromboembolic events within 6 months prior to Baseline or severe or unstable angina, New York Heart Association (NYHA)
- •Class III or IV disease, or a QTCB (corrected according to Bazett’s formula) interval > 470 msec
- •- Serious uncontrolled cardiac arrhythmia grade II or higher according to NYHA
- •- Uncontrolled hypertension (systolic > 150 and/or diastolic > 100 mm Hg)
- •- Acute and chronic, active infectious disorders and non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy
- •- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease,
- •uncontrolled nausea, vomiting, diarrhea,malabsorption syndrome)
- •- Another active cancer (excluding adequately treated basal cell carcinoma or cervical intraepithelial neoplasia [CIN]/cervical carcinoma in situ or melanoma in situ). Prior history of other cancer is allowed as long as there is no active disease within the prior 5 years.
- •8. Major surgery within 28 days before randomization
- •9. Positive hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection at screening
- •10. History of non-compliance to medical regimens
- •11. Subjects unwilling to or unable to comply with the protocol
- •12. Subject is currently receiving treatment with any agent listed on the prohibited medication list (See Section 6.6 Concomitant Medications/Treatments for complete list)
- •13. Treatment with any investigational product within < 4 half-lives for each individual investigational product OR within 28 days prior to randomization
- •14. Current treatme
研究者
相似试验
进行中（未招募）
1 期
A Study Assessing The Efficacy And Safety Of GTx-024 In Patients With Estrogen Receptor Positive and Androgen Receptor Positive Breast CancerEstrogen Receptor Positive and Androgen Receptor Positive Breast CancerMedDRA version: 19.0Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: LLTClassification code 10072740Term: Locally advanced breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10070577Term: Oestrogen receptor positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-001012-35-LTGTx, Inc.88
进行中（未招募）
1 期
A Study Assessing The Efficacy And Safety Of GTx-024 In Patients With Estrogen Receptor Positive and Androgen Receptor Positive Breast CancerEstrogen Receptor Positive and Androgen Receptor Positive Breast CancerMedDRA version: 19.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: LLTClassification code 10072740Term: Locally advanced breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: PTClassification code 10070577Term: Oestrogen receptor positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-001012-35-HUGTx, Inc.118
进行中（未招募）
1 期
A Study Assessing The Efficacy And Safety Of GTx-024 In Patients With Triple Negative Breast CancerAndrogen Receptor-Positive Triple Negative Breast Cancer (AR+ TNBC)MedDRA version: 19.0Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10006198Term: Breast cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-004989-23-LTGTx, Inc.55
进行中（未招募）
1 期
A Study Assessing The Efficacy And Safety Of GTx-024 In Patients With Triple Negative Breast CancerEUCTR2014-004989-23-GBGTx, Inc.55
招募中
2 期
A Phase 2, Multicenter, Multinational, Open-Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of ORGN001 (formerly ALXN1101) in Pediatric Patients with Molybdenum Cofactor Deficiency (MoCD) Type A Currently Treated with Recombinant Escherichia coli-derived Cyclic Pyranopterin Monophosphate (rcPMP)and aldehyde oxidaseCombined deficiency of sulfite oxidasexanthine dehydrogenase10027664NL-OMON55625Origin Biosciences, Inc.2