A Randomized, Open-Label Phase 2 Study of EC145 Single-agent and the Combination of EC145 plus Docetaxel Versus Docetaxel Alone in Participants with Folate-Receptor Positive [FR(++)] Second Line NSCLC - TARGET NSCLC:Trial to Assess benefit of folate-Receptor tarGEteted Treatment of second-line NSCLC

Endocyte, Inc.0 个研究点目标入组 180 人开始时间: 2012年11月15日最近更新: 2015年8月17日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Endocyte, Inc.
入组人数: 180

研究概览入排标准研究者记录与标识符相似试验

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

•1. Participants must have the ability to sign an approved informed consent form (ICF).
•2. Participants must be = 18 years of age.
•3. Participants must have histology confirmed diagnosis of NSCLC (adenocarcinoma, squamous, adenosquamous carcinoma, or adenocarcinoma with other NSCLC variants of the lung) (Stage IIIB or IV).
•4. Participants must have all (RECIST v1.1-defined) target lesions positive for the folate receptor [FR(++)] by SPECT scan.
•5. Only one prior systemic therapy for advanced disease (e.g., a platinum doublet or a maintenance regimen that includes a platinum doublet; in addition, the participant may have received an epidermal growth factor receptor [EGFR] inhibitor).
•6. For the purpose of obtaining a RECIST v1.1 baseline scan, participants must have a radiological evaluation conducted no more than 28 days prior to beginning study therapy. Note: For participants with a history of CNS metastasis, or with current signs/symptoms of neurological compromise, baseline radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast).
•7. Participants must have radiologic evidence of disease progression following the most recent prior treatment.
•8. Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0–1.
•9. Participants must have recovered (to baseline/stabilization) from prior cytotoxic therapy-associated acute toxicities.
•10. Participants with prior radiation therapy are eligible if they meet the following criteria:
•a. Previous radiation therapy is allowed to <25% of the bone marrow, but whole pelvis radiation is excluded.
•b. Prior radiotherapy must be completed at least 2 weeks before patient is randomized.
•c. Participants must have recovered from the acute toxic effects of the treatment before randomized.
•d. Prior thoracic radiation must be completed 30 days before study enrollment.
•e. Irradiated pulmonary lesions cannot be used as target or non-target lesions (and must be excluded) unless there is previous documented progression of these lesions.
•f. Palliative extrathoracic radiotherapy can continue, but these lesions must be excluded as target and non-target lesions.
•11. Participants must have adequate organ function:
•a. Bone marrow reserve:i. Absolute neutrophil count (ANC) = 1.5 x 10(9)/L. Platelets = 100 x 10(9)/L. Hemoglobin = 9 g/dL.
•ii. Use of supportive care measures (eg, use of white blood cell [WBC] growth factors, antiemetics, or epoetin) should follow ASCO guidelines. Participants should receive full supportive care, including transfusion of blood as mandated by clinical need; however, transfusions administered for the sole purpose of meeting the study inclusion criteria between the time informed consent is signed and first dose of EC145 and or docetaxel is administered are not allowed.
•b. Hepatic: Total bilirubin = 1.5 x the upper limit of normal (ULN). Alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), and lactate dehydrogenase (LDH) and alkaline phosphatase = 2.5 x ULN.
•c. Renal: Serum creatinine = 1.5 x ULN, or for participants with serum creatinine > 1.5 ULN, creatinine clearance = 50 mL/min/1.73 m2 (50 mL/min/1.73m2 is equivalent to 0.83 mL/s/m2).
•12. Participants of childbearing potential:
•a. Women who are capable of becoming pregnant must have a negative serum pregnancy test within 1 week prior to exposure to EC20 and within 1 week prior to treatment with EC145 and/or do

排除标准

•1. Prior therapy with docetaxel, vinorelbine, or vinca-containing compounds.
•2. Known hypersensitivity to docetaxel or polysorbate 80.
•3. Symptomatic central nervous system (CNS) metastases or metastases that result in midline shift, significant edema. Patients who received treatment for CNS metastases with steroids or anti-seizure medications should be off all medications for at least 7 days prior to randomization. At least 2 weeks should have elapsed from CNS radiotherapy (including WBRT, stereotactic radiotherapy, etc)
•4. Malignancies other than NSCLC that are expected to alter life expectancy or may interfere with disease assessment. For instance, patients with adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or low-grade (Gleason score = 6) localized prostate cancer and patients with prior history of malignancy who have been disease-free for more than 3 years are eligible.
•5. Serious cardiac illness or medical conditions such as unstable angina, pulmonary embolism, or uncontrolled hypertension.
•6. Antifolate therapy such as methotrexate for rheumatoid arthritis).
•7. Baseline peripheral neuropathy CTCAE = Grade 2.
•8. Pregnant or lactating women.
•9. Other concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy.
•10. Active infections (eg, hepatitis or HIV carriers)

研究者

发起方

Endocyte, Inc.

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