NCT04143789Unknown1 期
A Phase 1/2 Dose Escalation Study of AP-002 In Patients With Advanced or Recurrent Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 61
- 试验地点
- 3
- 主要终点
- Safety Assessment
研究概览
简要总结
The purpose of this trial is to define an effective and safe dose of AP-002 in advanced or recurrent solid tumors for which there are no standard therapies to use in subsequent studies in advanced or recurrent breast, non-small cell lung cancer (NSCLC) or prostate cancers.
详细描述
The Phase 1 portion of this study will determine the Pharmacodynamically Active Dose (PAD) of AP-002 in humans, defined as the dose at which the plasma concentration of AP-002, as measured by Ga, is 300-500 ng/mL and which is at or below the Maximum Tolerated Dose (MTD), to use in the clinical setting of advanced or recurrent solid tumors. This will be followed by a Phase 2 expanded cohort treated at the PAD, to estimate the efficacy of AP-002 in patients with advanced or recurrent breast cancer, NSCLC and prostate cancer.
Patients will receive AP-002 orally, once daily for 14 days of a 21 day cycle.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 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
- •Phase 1: Patients with advanced or recurrent solid tumors with target (± non-target) or with only non-target disease, for which there is no standard therapy available Phase 2: Patients with advanced or recurrent breast cancer, NSCLC, or prostate cancer with target (± non-target) or with only non-target disease for which there is no standard therapy available
- •Patients with bone metastases but without target disease are eligible
- •Patients with bone metastases must have at least one bone lesion that has not received radiation therapy within 6 weeks prior to Cycle 1 Day 1
- •Patients must discontinue bisphosphonate and/or denosumab treatment.
- •Age ≥ 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- •O2 saturation ≥ 92% on room air per pulse oximetry
- •Exhaled nitrous oxide ≤ 50 parts per billion (ppb)
- •Adequate hematologic, hepatic and renal function defined as:
- •Hemoglobin ≥ 9 g/dL
- •Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
- •Platelet count ≥ 75 × 109/L
- •Total bilirubin ≤ 2 × upper limit of normal (ULN). Patients with an established diagnosis of Gilberts syndrome with an unconjugated bilirubin ≤ 2 mg/dL and conjugated bilirubin within normal limits (WNL) are eligible.
- •Serum electrolytes WNL
- •Transaminases ≤ 3 × ULN
- •Prothrombin time (PT)/international normalized ratio (INR), thromboplastin time (PTT), or activated PTT (aPTT) ≤ 1.5 × ULN. For patients on therapeutic coumadin, PT (INR) ≤ 2.5 × ULN is acceptable; for patients on therapeutic heparin, PTT (or aPTT) ≤ 2.5 × ULN
- •Corrected creatinine clearance ≥ 40 mL/minute, based on the Cockcroft-Gault equation
- •Patient must have discontinued prior antineoplastic therapy at least 21 days prior to Cycle 1 Day 1 and have recovered or stabilized from any prior AEs related to the prior therapy
- •Provision of signed and dated informed consent form
- •Serum 25-hydroxyvitamin D ≥ 30 ng/mL by investigative site laboratory at screening
排除标准
- •Evidence of benign primary hyperparathyroidism, hyperthyroidism, adrenal insufficiency, vitamin D intoxication, mild alkali syndrome, sarcoidosis or other granulomatous disease
- •Treatment with calcitonin, mithramycin or cinacalcet within 7 days prior to the date of the screening
- •Receiving dialysis for renal failure
- •Patients with a known history of clinically significant active infection, including human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- •Patients with active central nervous system (CNS) metastases are not eligible, but patients with treated, stable CNS metastases are allowed
- •Patients with QT interval of ≥ 480 msec on ECG
- •Patients with Paget's disease of bone
- •Patients of childbearing potential unwilling to abstain from sexual intercourse, or employ effective barrier methods of contraception during participation in this trial
- •Pregnancy or lactation. A negative pregnancy test will be required for women of childbearing potential prior to study enrollment and will be repeated throughout the study. Women of childbearing potential will be defined as women who have not had natural or pharmacologic menopause, nor surgical sterilization.
- •Patients unwilling or unable to take oral medication, requiring a nasogastric or gastrostomy tube, or unwilling to adhere to the treatment regimen and fasting requirements
- •Patients unwilling to comply with all study procedures or who are unavailable for the duration of the study
- •Known allergies to any components of the AP-002 Drug Product
研究组 & 干预措施
Tablets to be taken orally daily for 14 of 21 day cycle
Experimental
AP-002 (4 mg and 20 mg tablets) to be taken orally daily for 14 days
干预措施: AP-002 (Drug)
结局指标
主要结局
Safety Assessment
时间窗: Through study completion/ up to 18 months
Number of participants with treatment-related adverse events (safety and tolerability) as assessed by CTCAE v4.0
Dose Assessment
时间窗: Up to 6 months
Define the recommended phase 2 dose
次要结局
- Efficacy Assessment(Through study completion/ up to 18 months)
- Pharmacokinetic Assessment(Through study completion/ up to 18 months)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
1 期
A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung CancerCarcinoma, Non-Small-Cell LungNCT06532032Janssen Research & Development, LLC12
进行中（未招募）
1 期
A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung CancerCarcinoma, Non-Small-Cell LungNCT05908734Janssen Research & Development, LLC71
已完成
1 期
A Study of Azenosertib (ZN-c3) and Niraparib in Subjects With Platinum-Resistant Ovarian CancerPlatinum-resistant Ovarian CancerOvarian CancerFallopian Tube CancerPrimary Peritoneal CarcinomaNCT05198804K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc117
进行中（未招募）
1 期
A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung CancerCarcinoma, Non-Small-Cell LungNCT05488314Janssen Research & Development, LLC57
终止
1 期
A Study of PLX51107 in Advanced MalignanciesSolid TumorsAcute Myeloid LeukemiaNon-Hodgkin's LymphomaMyelodysplastic SyndromeNCT02683395Plexxikon50