EUCTR2008-005074-12-ES进行中（未招募）1 期
A Phase 1b/2 Open Label, Dose Escalation Study of AMG 655 in Combination with AMG 479 in Subjects with Advanced, Refractory Solid Tumors.--------------------------------------------------------Estudio abierto de fase 1b/2 con escalada de dosis de AMG 655 en combinación con AMG 479 en sujetos con tumores sólidos refractarios y avanzados.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 108
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
- All
入选标准
- •Disease Related
- •- Part 1: Histologically or cytologically confirmed, locally advanced or metastatic,
- •treatment-refractory solid tumors
- •- Part 2: Histologically or cytologically confirmed, locally advanced or metastatic
- •- NSCLC (squamous or non-squamous cell carcinoma; up to 2 prior treatment regimens)
- •- CRC (up to 2 prior treatment regimens)
- •- Pancreatic cancer (up to 1 prior treatment regimen)
- •- Ovarian cancer (up to 2 prior treatment regimens), or
- •- Sarcoma (up to 2 prior treatment regimens)
- •- according to cohort availability
- •- Part 2: Measurable disease according to modified RECIST (at least 1 measurable
- •- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix G)
- •- Life expectancy ≥ 3 months
- •Demographic.
- •- Women or men ≥ 16 years of age
- •- Before any study-specific procedure, the appropriate written informed consent must
- •be obtained (Section 12.1)
- •Within 7 days before enrollment, the following test results must be obtained:
- •- Hematological function, as follows:
- •- Hemoglobin ≥ 9 g/dL
- •- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- •- Platelet count ≥ 100 x 109/L
- •(without transfusion ≤ 14 days prior to enrollment)
- •- Renal function, as follows:
- •- Serum creatinine ≤ 2 x ULN
- •- Hepatic function, as follows:
- •- Aspartate aminotransferase (AST; SGOT) ≤ 2.5 x ULN
- •( 5 x ULN if attributable to liver metastases)
- •- Alanine aminotransferase (ALT; SGPT) ≤ 2.5 x ULN
- •(≤ 5 x ULN if attributable to liver metastases)
- •- Total Bilirubin ≤ 1.5 x ULN
- •(≤ 3 x ULN for subjects with UGT1A1 promoter polymorphism ie, Gilbert syndrome, confirmed by genotyping or Invader UGT1A1 molecular assay prior to enrollment)
- •- Coagulation:
- •- Partial thromboplastin time (PTT) ≤ 1.3 x ULN
- •- International normalized ratio (INR) ≤ 1.5,
- •- Amylase ≤ 2 x ULN
- •- Lipase ≤ 2 x ULN
- •- Adequate glycemic function, for subjects with known diabetes (Type 1 or 2), as
- •- Must be controlled with a glycosylated hemoglobin (HgbA1c) of ≤ 8.0%
- •- Documented fasting blood sugars ≤ 160 mg/dL. Diabetic subjects who have
- •recently had their glycemic control regimens adjusted and have documented fasting blood glucose concentrations ≤ 160 mg/dL may be considered regardless of HgbA1c value, if per investigator discretion they are considered to have adequate glycemic function
- •- Negative pregnancy test within 3 days prior to enrollment (females of child-bearing potential only)
- •- Plan to begin protocol specific therapy ≤ 7 days after enrollment
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Disease Related
- •- Presence of uncontrolled central nervous system (CNS) disease:
- •- Subjects with CNS metastases that are both definitively treated and
- •stably controlled are eligible if all of the following apply:
- •(1) definitive therapy has been administered (surgery and/or radiation therapy);
- •(2) there is no additional treatment planned for brain metastases;
- •(3) the subject is clinically stable; and
- •(4) the subject is off corticosteroids or on a stable dose of corticosteroids for at
- •least 14 days prior to enrollment.
- •- Part 2: Any prior or synchronous other malignancy, except:
- •- Malignancy treated with curative intent and with no known active disease present
- •for ≥ 3 years before enrollment and considered to be at low risk for recurrence by
- •the treating physician
- •- Adequately treated non-melanoma skin cancer or lentigo maligna without
- •evidence of disease
- •- Adequately treated cervical carcinoma in situ without evidence of disease
- •- Prostatic intraepithelial neoplasia without evidence of prostate cancer
- •Cancer Therapy
- •- Systemic chemotherapy, hormonal therapy, immunotherapy, experimental or
- •approved anticancer proteins/antibodies therapy ≤ 28 days before enrollment,
- •- In Part 1, patients may continue approved hormonal therapy as medically
- •- Unresolved toxicity(ies) from prior anti-cancer therapy, which may increase the risks
- •associated with study participation
- •- Prior treatment with death receptor agonists (including but not limited to
- •rhApo2L/TRAIL [AMG 951], apomab, mapatumumab, lexatumumab, CS-1008)
- •- Prior treatment with IGF receptor antagonists (including but not limited to
- •CP-751,871, MK0646, AVE1642 or IMC-A12)
- •- Patients may not have received prior radiotherapy to > 25% of the bone marrow.
- •Radiation must have been concluded ≥ 14 days prior to enrollment. Patients must
- •have recovered from all potential side effects and must be clinically stable.
- •Medications/ Treatments
- •- Therapeutic anticoagulation treatment within 7 days prior to enrollment.
- •- Prophylactic anticoagulation of venous access devices (eg, with low-dose
- •coumadin [1-2 mg/day] or low-dose heparin) is allowed, provided PTT and INR
- •eligibility criteria are met.
- •- Recent infection requiring systemic anti-infective treatment that was completed
- •- 14 days before enrollment (with the exception of uncomplicated urinary tract
- •infection or upper respiratory tract infection)
- •Medical Conditions
- •- Major surgical procedure ≤ 28 days before enrollment, or not yet recovered from
- •prior major surgery
- •- Minor surgical procedure (eg, open biopsy) ≤ 7 days before enrollment, or not yet
- •recovered from prior minor surgery.
- •Note: uncomplicated placement of vascular access device, fine needle aspiration,
- •thoracocentesis or paracentesis ≥ 3 days prior to enrollment is acceptable
- •- History of bleeding diathesis
- •- Pulmonary embolism or arterial/venous thromboembolism within 6 months
- •- Known positive test for human immunodeficiency virus, hepatitis C virus or acute or
- •chronic hepatitis B infection
- •- Any clinically significant medical or psychiatric condition, co-morbid disease,
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