NCT02559674已完成1 期
Phase Ib/II Study of ALT-803 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Advanced Pancreatic Cancer
Altor BioScience2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2016年7月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Determination of MTD; Phase Ib
研究概览
简要总结
This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose escalation study of ALT-803 in combination with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer in conjunction with gemcitabine and nab-paclitaxel.
详细描述
The purpose of this study is to evaluate the safety and tolerability of escalating doses, to identify the Maximum Tolerated Dose (MTD) and designate a dose level for Phase II study (RP2D) of ALT-803 administered in combination with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer.
To access the anti-tumor activity of ALT-803 administered in combination with gemcitabine and nab-paclitaxel as measured by objective response rate, overall survival, progression-free survival, time to progression, and duration of response in patients with advanced pancreatic cancer.
To Characterize the pharmacokinetic, immunogenicity, and serum cytokine profile of ALT-803 in combination with gemcitabine and nab-paclitaxel in treated patients. To correlate circulating cell free DNA and circulating tumor DNA with clinical outcomes of the study in treated patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Inclusion Criteria:
- •Histologically or cytologically confirmed diagnosis of pancreatic cancer.
- •For dose escalation phase (Phase Ib) distant metastatic disease or unresectable disease and not a candidate for down staging to resection.
- •For expansion phase (Phase II) distant metastatic disease only.
- •For dose escalation phase (Phase Ib) 0 or 1 prior lines of chemotherapy for advanced pancreatic cancer. Prior gemcitabine is allowed, however prior nab-paclitaxel is not allowed.
- •For expansion phase (Phase II) no prior therapy for pancreatic cancer is allowed except for adjuvant therapy as long as it was completed ≥ 6 months prior to study treatment start
- •Have at least one untreated and progressing tumor lesion that can be accurately measured according to Response Evaluation Criteria in Solid Tumor
- •Prior radiation is allowed if the index lesion(s) remains outside of the treatment field or has progressed since prior treatment. Radiation therapy must have been completed at least 4 weeks prior to the baseline scan
- •Resolved acute effects of any prior therapy to baseline or Grade ≤1
- •The Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
- •Life expectancy ≥12 weeks
- •Glomerular Filtration Rate (GFR) > 40mL (milliliter)/min; Creatinine ≤ 1.5 x ULN (Upper limit of Normal)
- •Platelets ≥100,000/uL (microliter)
- •Hemoglobin ≥ 9g/dL
- •Absolute Lymphocytes ≥800/uL
- •Absolute neutrophil count/absolute granulocyte count ≥1500/uL
- •Total bilirubin ≤ 2.0 X ULN, or ≤ 3.0 X ULN (for patients with Gilbert's Syndrome)
- •aspartate aminotransferase, alanine aminotransferase ≤ 2.5 X ULN, or ≤ 5.0 X ULN (if liver metastasis present)
- •Normal clinical assessment of pulmonary function
- •Negative serum pregnancy test if female and of childbearing potential
- •Subjects, both females and males, with reproductive potential must agree to use effective contraceptive measures for the duration of the study
- •Must provide informed consent and HIPPA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations
排除标准
- •No women who are pregnant or nursing
- •No known hypersensitivity to gemcitabine or nab-paclitaxel
- •No concurrent herbal or unconventional therapy
- •No prior therapy with IL-15 or IL-15 analog
- •No ongoing toxicity from prior anti-cancer treatment that may interfere with study treatment. All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must resolve to grade 1 or baseline before administration of the study treatment.
- •No positive Hep C serology or active Hep B infection
- •No congestive heart failure < 6 months
- •No unstable angina pectoris < 6 months
- •No myocardial infarction < 6 months
- •No history of ventricular arrhythmias or severe cardiac dysfunction
- •No history of uncontrollable supraventricular arrhythmias
- •No New York Heart Association Class > II congestive heart failure
- •No marked baseline prolongation of QT/QTc interval
- •No known autoimmune disease requiring active treatment. Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
- •No known prior organ allograft or allogeneic transplantation
- •No known HIV-positive or AIDS unless patient is on a stable highly active antiretroviral therapy (HAART) regimen, have CD4 (cluster of differentiation 4) counts >350, with no detectable viral load on quantitative polymerase chain reaction test
- •No untreated central nervous system metastases, or if treated must be neurologically stable for at least 2 weeks prior to enrollment
- •No corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent)
- •No psychiatric illness/social situation that would limit compliance
- •No other illness that in the opinion of the investigator would exclude the subject from participating in the study
- •No active systemic infection requiring parenteral antibiotic therapy
- •No anti-cancer treatment including surgery, radiotherapy, chemotherapy, other immunotherapy, or investigational therapy within 14 days before treatment start
- •No disease requiring systemic immunosuppressive therapy
- •No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 3 years after surgical treatment.
结局指标
主要结局
Determination of MTD; Phase Ib
时间窗: 9 Months
Determine the maximum tolerated dose (MTD) level and designate the recommended dose level for phase II.
Safety Profile (Number and severity of treatment related AEs); Phase Ib and II
时间窗: 48 Months
Number and severity of treatment related adverse events (AEs) that occur or worsen after the first dose of study treatment
Overall Survival; Phase II
时间窗: 8.5 Months
Determine the 8.5 month overall survival of treated patients
次要结局
- Time to progression(72 Months)
- Progression-free survival(72 Months)
- Objective response rate(72 Months)
- Duration of response(72 Months)
- Biomarkers; Phase Ib(36 Months)
- Correlation between the level of circulating cell free DNA in patient plasma and response to study treatment(36 Months)
- Correlation between the level of tumor DNA in patient plasma and response to study treatment(36 Months)
- Determine the level of anti-ALT-803 antibodies in patient serum(36 Months)
- Area under the plasma concentration-time curve from time zero to infinity (AUC); Phase Ib(36 Months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A Study of ALT-801 in Combination With Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial CancerTransitional Cell Carcinoma of BladderUrethra CancerUreter CancerMalignant Tumor of Renal PelvisNCT01326871Altor BioScience68
Unknown
1 期
QUILT-3.005: A Study of ALT-803 in Patients With Relapsed or Refractory Multiple MyelomaRelapsed or Refractory Multiple MyelomaNCT02099539Altor BioScience18
已完成
1 期
Safety and Efficacy Study of ALT-801 to Treat Progressive Metastatic MalignanciesProgressive Metastatic MalignanciesNCT00496860Altor BioScience26
终止
1 期
A Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-Muscle Invasive Bladder CancerNon-muscle Invasive Bladder CancerNCT01625260Altor BioScience12
终止
1 期
QUILT-2.008: Study of ALT-801 With Cisplatin in Patients With Metastatic MelanomaMetastatic MelanomaNCT01029873Altor BioScience22