JPRN-jRCT2080221951未知1 期
A Phase 1, 2, Open-label Study to Evaluate the Safety and Tolerability of Vandetanib 300 mg/Day in Japanese Patients With Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma
适应症
试验速览
- 阶段
- 1 期
- 发起方
- AstraZeneca
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Written consent from female or male Japanese patients aged 20 years and over. Evidence of non-childbearing status for women of childbearing potential, or postmenopausal status.
- •- Previous diagnosis of unresectable, locally advanced or metastatic, hereditary or sporadic Medullary Thyroid Carcinoma(MTC).
- •- Patients who have a good overall health status(World Health Organization (WHO) Performance status 0-2).
- •- Patients who have appropriate renal conditions confirmed by test results for taking part in the study.
- •- For patients with measurable disease(at least one lesion, not irradiated within 12 weeks of study registration, with longest diameter more or equal 10mm (lymph nodes minimum more or equal 15 mm) with CT or MRI).
排除标准
- •- Patients with brain metastases or spinal cord compression.
- •- Patients with significant abnormal ECG (QTcB correction unmeasurable or more than 480 ms)findings and /or significant cardiac conditions or events, uncontrolled hypertension and evidence of severe lung disease.
- •- Abnormal electrolytes such as potassium, magnesium and calcium, or abnormal organ functions such as decreased creatinine clearance.
- •- Patients with significant abnormal laboratory findings (to include abnormal liver function tests (bilirubin more than 1.5xULRR, and ALT, AST, or ALP more than 2.5xULRR or 5.0xULRR if related to liver metastases)).
- •- Prior treatment (major surgery, radiation therapy, chemotherapy, or other investigational drugs) received within 28 days before registration.
研究者
相似试验
已完成
1 期
A Study of Lazertinib as Monotherapy or in Combination with Amivantamab in Participants with Advanced Non-small Cell Lung CancerJPRN-jRCT2080224850Janssen Pharmaceutical K.K.520
已完成
不适用
A Phase Ib/II, open label study evaluating the safery and pharmacokinetics of GDC-0199 (ABT-199) in combination with Rituximab (R) or Obinutuzumab (G) plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with B Cell non-hodgkin's lymphoma (NHL) and DLBCNon-Hodgkin's Lymphoma10025320NL-OMON45171Hoffmann-La Roche21
进行中（未招募）
1 期
A Safety and Pharmacokinetics Study of GDC-0199 (ABT-199) in Patients With Non-Hodgkin's LymphomaEUCTR2013-003749-40-CZF. Hoffmann- La Roche Ltd.264
进行中（未招募）
1 期
A Safety and Pharmacokinetics Study of GDC-0199 (ABT-199) in Patients With Non-Hodgkin's LymphomaB-cell non-hodgkin's lymphoma (NHL) and diffuse large B-cell lymphoma (DLBCL)MedDRA version: 20.0 Level: PT Classification code 10012821 Term: Diffuse large B-cell lymphoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10029601 Term: Non-Hodgkin's lymphoma refractory System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10029600 Term: Non-Hodgkin's lymphoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10029547 Term: Non-Hodgkin's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10012822 Term: Diffuse large B-cell lymphoma refractory System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10012818 Term: Diffuse large B-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-003749-40-ATF. Hoffmann- La Roche Ltd.264
进行中（未招募）
1 期
A Safety and Pharmacokinetics Study of GDC-0199 (ABT-199) in Patients With Non-Hodgkin's LymphomaEUCTR2013-003749-40-HUF. Hoffmann- La Roche Ltd.264