EUCTR2011-005215-86-PL进行中（未招募）1 期
A Phase 1/2, Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of Oral CO-1686 in Patients with Previously Treated Mutant EGFR Non-small Cell Lung Cancer (NSCLC)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 612
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
- •For Phase 1 and Phase 2:
- •Histologically or cytologically confirmed metastatic or unresectable locally advanced, recurrent NSCLC
- •Documented evidence of any activating mutation in the EGFR determined by either deoxyribonucleic acid (DNA) sequencing or polymerase chain reaction (PCR)-based testing of the NSCLC tumor using central laboratory assessment as documented evidence.
- •Have undergone a biopsy of either primary or metastatic tumor tissue within 60 days of dosing study drug and have tissue available to send to sponsor lab or are able to undergo a biopsy during screening. No change (except for washout or dose adjustment if required to manage adverse effects) in antitumor therapy regimen is allowed between the biopsy and CO-1686 initiation.
- •Life expectancy of at least 3 months
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •Age =18 years
- •Adequate hematological and biological function, confirmed by the following laboratory values:
- •Bone Marrow Function
- •-Absolute neutrophil count (ANC) = 1.5 x 10e9/L
- •-Platelets >100.0 × 10e9/L
- •-Hemoglobin =9 g/dL (or 5.6 mmol/L)
- •Electrolytes
- •-Potassium and magnesium within normal range. Patients may receive supplements to meet this requirement
- •Hepatic Function
- •-Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =3 × upper limit of normal (ULN); if liver metastases, =5 × ULN
- •-Bilirubin =2 × ULN
- •Renal Function
- •-Serum creatinine =1.5 × ULN
- •Written consent on an Institutional Review Board/Independent Ethics Committee-approved Informed Consent Form (ICF) prior to any study-specific evaluation
- •Patients enrolling into Phase 1 must also meet the following inclusion criteria:
- •Prior treatment with EGFR-directed therapy (e.g. erlotinib, gefitinib, neratinib, afatinib, or dacomitinib [PF299804]). Prior chemotherapy, including intervening chemotherapy, is allowed.
- •-The washout period for an EGFR TKI is a minimum of 3 days.
- •-The washout period for chemotherapy is a minimum of 14 days.
- •-Any toxicity related to prior treatment must have resolved to Grade 1 or less.
- •Be willing and able to eat a high-fat breakfast on Day 1 of the study (only applicable to food-effect cohort)
- •Patients enrolling into Phase 2 (Cohort A) must also meet the following inclusion criteria:
- •Disease progression while on treatment with EGFR-directed therapy (e.g. erlotinib, gefitinib, neratinib, afatinib, or dacomitinib [PF299804]). Prior chemotherapy, including intervening chemotherapy before planned inititation of CO-1686, is allowed.
- •a) The washout period an EGFR TKI is a minimum of 3 days
- •b) The washout period for chemotherapy is a minimum of 14 days
- •- Any toxicity related to prior treatment must have resolved to Grade 1 or less
- •Documented evidence of T790M mutation in EGFR determined by PCR-based testing of the tumor tissue using sponsor central lab following dis
排除标准
- •Any of the following criteria will exclude patients from study participation:
- •Documented evidence of an Exon 20 insertion activating mutation in the EGFR
- •Active second malignancy, i.e. patient known to have potentially fatal cancer present for which he/she may be (but not necessarily) currently receiving treatment.
- •- Patients with a history of malignancy that has been completely treated, with no evidence of that cancer currently, are permitted to enroll in the trial provided all chemotherapy was completed >6 months prior and/or bone marrow transplant >2 years prior
- •History of interstitial lung disease related to prior EGFR inhibitor therapy
- •Patients with Leptomeningeal carcinomatosis are excluded. Other CNS metastases are only permitted if treated, asymptomatic, and stable (not requiring steroids for at least 4 weeks prior to start of study treatment).
- •Treatment with prohibited medications (e.g., concurrent anticancer therapy including other chemotherapy, radiation therapy, or hormonal treatment [except corticosteroids and megesterol acetate], or immunotherapy) =14 days prior to treatment with CO-1686
- •Prior treatment with CO-1686, or other drugs that target T790M positive, mutant EGFR with sparing of wild type EGFR, eg. AZD9291, HM61713, TAS-121
- •Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericia’s method (QTcF) >450 msec (males) or >470 msec (females),
- •Family history of long QT syndrome
- •b. Inability to measure QT interval on ECG
- •c. Resting bradycardia < 55 beats/min
- •Implantable pacemaker or implantable cardioverter defibrillator
- •Treatment with any medication known to produce QT prolongation (see Appendix C for a partial list of prohibited medicines)
- •Non-study related surgical procedures = 7 days prior to administration of CO 1686. In all cases, the patient must be sufficiently recovered and stable before treatment administration.
- •Females who are pregnant or breastfeeding
- •Refusal to use adequate contraception for fertile patients (females and males) for 6 months after the last dose of CO-1686
- •Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, uncontrolled psychiatric condition, uncontrolled intercurrent illness including active infection, arterial thrombosis, and symptomatic pulmonary embolism)
- •Any other reason the investigator considers the patient should not participate in the study
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