EUCTR2013-003749-40-ES进行中（未招募）1 期
A Phase Ib/II, open label study evaluating the safety 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 DLBC
Roche Farma, S.A. en nombre de F. Hoffmann- La Roche Ltd.0 个研究点目标入组 264 人开始时间: 2014年12月22日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 264
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
- •General Inclusion Criteria:
- •- Patients, age >= 18 years
- •- At least one bi-dimensionally measurable lesion defined as > 1.5 cm in its longest dimension
- •- Ability and willingness to comply with the study protocol procedures
- •- Confirmed availability of archival or freshly biopsied tumor tissue prior to study enrollment
- •- ECOG performance status of 0, 1, or 2
- •- Adequate hematologic function
- •- For female patients of childbearing potential and male patients with female partners of childbearing potential, agreement to use highly effective forms of contraception
- •Dose Escalation Portion of the Study:
- •- Patients must have histologically confirmed B-cell non- Lymphoma (NHL)
- •- Patients must have never received previous R-CHOP treatment
- •- Any relapsed/refractory patients that are enrolled during the dose escalation should have received only a single previous treatment regimen
- •Expansion Portion of the Study:
- •- Patients must have previously-untreated diffuse large, B-cell lymphoma
- •- International prognostic index (IPI) score must be 2-5
- •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 125
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 125
排除标准
- •General Exclusion Criteria:
- •- Contraindication to receive any of the individual components of CHOP, rituximab or obinutuzumab
- •- Primary CNS lymphoma
- •- Vaccination with live vaccines within 28 days prior to randomization
- •- History of other malignancy that could affect compliance with the protocol or interpretation of results
- •- Evidence of significant, concomitant disease or illness
- •- Use of CYP3A inhibitors or inducers within 7 days of the first dose of GDC-0199
- •- Requires use of Warfarin
- •- Recent major surgery
- •- Women must not be pregnant or breastfeeding
- •Dose Escalation Portion of the Study:
- •- Prior anthracycline therapy
- •- Chemotherapy or other investigational therapy within 5 half-lives of a biologic agent with a minimum of 28 days prior to the start of Cycle 1
- •- histologically confirmed mantle cell lymphoma (MCL) or small lymphocytic lymphoma (SLL)
- •Expansion Portion of the Study:
- •- Patients with transformed lymphoma
- •- Prior therapy for non-hodgkin's lymphoma (NHL)
- •- Current Grade > 1 peripheral neuropathy
研究者
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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: 18.1Level: PTClassification code 10012821Term: Diffuse large B-cell lymphoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10029601Term: Non-Hodgkin's lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10029547Term: Non-Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10029600Term: Non-Hodgkin's lymphoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10012822Term: Diffuse large B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-003749-40-NLF. Hoffmann- La Roche Ltd.264