EUCTR2014-001855-22-NL进行中（未招募）1 期
Phase I/II study with the combination of afatinib and selumetinib in advanced KRAS mutant positive and PIK3CA wildtype non-small cell lung cancer and colorectal cancer
etherlands Cancer Institute- Antoni van Leeuwenhoek Hospital0 个研究点目标入组 140 人开始时间: 2014年10月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
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
- •1.Histological or cytological proof of advanced NSCLC or CRC. For PART B: treated with first line therapy for metastatic disease only.
- •2.Written documentation of a known pathogenic KRAS (exon 2, 3 or 4) mutation and PIK3CA wildtype (defined as absence of mutations in exon 9 and 20).
- •3.Age > 18 years.
- •4.Able and willing to give written informed consent.
- •5.WHO performance status of 0 or 1.
- •6.Able and willing to undergo blood sampling for PK and PD analysis.
- •7. Able and willing to undergo a tumor biopsy prior to start and upon progression of disease and in Part A after two weeks of therapy
- •8.All toxicities related to prior treatment should have resolved to CTCAE grade 1 or less (excluding alopecia)
- •9.Life expectancy > 3 months allowing adequate follow up of toxicity evaluation and antitumor activity.
- •10.Measurable disease according to RECIST 1.1
- •11.Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization and agree to use effective contraception throughout the treatment period, and for 4 months after the last dose of study treatment.
- •12.Adequate organ system function measured by laboratory values
- •Are the trial subjects under 18? no
- •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 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 160
排除标准
- •1.Any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment.
- •2.History of another malignancy
- •Exception PART A: Patients who have been disease-free for at least 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent second malignancies are eligible.
- •Exception PART B: Adequately treated carcinoma in situ of the cervix and adequately treated basal cell carcinoma of the skin.
- •3.Patients with pancreatic cancer treated with fluoropyrimidine containing therapy (PART B only).
- •4.Symptomatic or untreated leptomeningeal disease.
- •5.Symptomatic brain metastasis. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid and anticonvulsant therapy (for at least 4 weeks) are allowed to enrol. Radiotherapy for brain metastasis must have been completed at least 6 weeks prior to start of study treatment. Brain metastasis must be stable with verification by imaging (e.g. brain MRI or CT completed at screening demonstrating no current evidence of progressive brain metastases). Patients are not permitted to receive anti-epileptic drugs or corticosteroids.
- •6.Patients previously treated with irinotecan, docetaxel, capecitabine (PART B only)
- •7.Patients previously treated with any drug known to interfere with EGFR, HER2, HER3, HER4 or MAPK- and PI3K-pathway components, including inhibitors of PTEN, PI3K, AKT, mTOR, BRAF, MEK and ERK.
- •8.Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral afatinib and selumetinib (e.g., ulcerative diseases, uncontrolled nausea, malabsorption syndrome, small bowel resection).
- •9.History of interstitial lung disease or pneumonitis
- •10.Women who are pregnant or breast feeding.
- •11.Unreliable contraceptive methods. Both men and women enrolled in this trial must agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: condom, sterilization, other barrier contraceptive measures preferably in combination with condoms).
- •12.Radio-, immuno- or chemotherapy within the last 2 weeks prior to receiving the first dose of investigational treatment. Palliative radiation (1x 8Gy) is allowed.
- •13.Patients who have undergone any major surgery within the last 4 weeks prior to starting study drug or who would not have fully recovered from previous surgery.
- •14.Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients.
- •15.Patients with known hepatitis B (HBV) or C virus (HCV).
- •16.Ophthalmological conditions as follows:
- •Intra-ocular pressure >21 mmHg, or uncontrolled glaucoma (irrespective of intra-ocular pressure)
- •Current or past history of retinal pigment epithelial detachment / central serous retinopathy
- •Current or past history of retinal vein occlusion
- •17.Patients with left ventricular ejection fraction (LVEF) < 55%.
- •18.Patients with cardiac comorbidities (myocardial infarct within 6 months of study start, NYHA class = III,
研究者
相似试验
进行中（未招募）
1 期
Afatinib in combination with cetuximab in EGFR exon 20 insertion positive non-small-cell lung cancerEGFR exon 20 insertion positive non-small cell lung cancerMedDRA version: 21.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-001521-97-NLStichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis37
已完成
2 期
Phase II single arm study of afatinib in combination with cetuximab in EGFR exon 20 insertion positive non-small-cell lung cancer10038666non-small cell lung cancerlung cancerNL-OMON55757Antoni van Leeuwenhoek Ziekenhuis37
进行中（未招募）
2 期
EJ025Bon-sequamous non-small cell lung cancerJPRN-jRCTs021200005Maemondo Makoto35
已完成
2 期
Phase II Study of First-Line Afatinib in Patients Aged 75 or Older With Advanced Lung Adenocarcinoma With EGFR MutationsElderly patients with NSCLC harboring sensitive EGFR mutationJPRN-UMIN000015834Osaka Lung Cancer Study Group38
招募中
不适用
Phase 2 study of afatinib in patients with previously treated advanced non-sq NSCLC haboring EGFR mutatioJPRN-UMIN000014981Gunma University Graduate School of Medicine55