Randomized Study Evaluating Molecular Profiling and Targeted Agents in Metastatic Cancer: Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT II)
概览
- 阶段
- 2 期
- 干预措施
- Targeted Therapy Based on Molecular Profiling
- 疾病 / 适应症
- Metastatic Malignant Neoplasm
- 发起方
- M.D. Anderson Cancer Center
- 入组人数
- 1362
- 试验地点
- 1
- 主要终点
- Comparison of Progression-Free Survival (PFS) Between the Two Randomized Arms
- 状态
- 进行中（未招募）
- 最后更新
- 2个月前
概览
简要总结
This randomized clinical trial studies how molecular profiling and targeted therapy work in treating patients with cancer that has spread to other places in the body compared to standard treatment. Information about genetic differences in a patient's tumor can be used to choose treatment that may target the tumor. It is not yet validated whether selecting treatment after studying the genetic changes that are associated with cancer in a patient's tumor is a better way to treat patients with metastatic cancer compared to therapy not based on studying the genetic changes that are associated with cancer.
详细描述
I. To determine whether patients treated with a matched targeted therapy selected on the basis of genomic alteration analysis of the tumor have longer progression-free survival (PFS) than those whose treatment is not selected on the basis of alteration analysis. Genomic analysis of tumor sample will be performed at the time of enrollment to identify tumor molecular alterations and to assign treatment for every individual patient. OUTLINE: After completion of molecular profiling, patients who qualify for the trial will be offered randomization as previously. If they wish to be randomized, patients will be randomized to one of the two arms: matched targeted therapy (ARM I) or other therapy (ARM II). Patients who decline to be randomized will then be offered their choice of the two trial arms. ARM I: Matched targeted therapy: Molecular profiling results are used to assign targeted therapy. Patients receive targeted therapy by participating in a Phase I or a Phase II clinical trial. If a clinical trial is not available, and a commercially available targeted therapy exists (Food and Drug Administration \[FDA\]-approved for another indication), patients can receive the FDA-approved drug. ARM II: Other therapy: Patients receive standard of care therapy at the discretion of the treating physician. Patients with tumor progression who achieve the primary study endpoint can cross over to the other treatment arm.
研究者
入排标准
入选标准
- •Patients with metastatic cancer
- •Patients may have received unlimited lines of prior therapy
- •Prior to randomization, patients with metastatic disease must have been treated with established standard-of-care therapy, or physicians have determined that such established therapy is not sufficiently efficacious, or patients have declined to receive standard-of-care therapy
- •The patient has measurable disease
- •The patient has Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •The patient has biopsy-accessible tumor; for patients who had no prior anticancer therapy and had surgical resection within a year and tumor tissue is immediately available, that tumor will be analyzed and no biopsy will be needed
- •Absolute neutrophil count \>= 1,000/ul
- •Platelets \>= 100,000/ul (unless these abnormalities are due to bone marrow involvement)
- •Total bilirubin level \<= 1.5 x the upper limit of normal (ULN), unless the patient has known Gilbert's disease
- •Alanine aminotransferase (ALT)/ serum glutamic pyruvic transaminase levels (SGPT) =\< 2.5 X ULN (unless the patient has liver metastases)
排除标准
- •Patients who are randomized to the control arm must not receive therapy based on prior molecular profiling
- •The patient has received chemotherapy, surgery, or radiotherapy (for therapeutic purposes) within 3 weeks of initiating study treatment (4 weeks for bevacizumab or investigational drugs) or the patient has not recovered (grade \>= 2 from side effects of the previous therapy); patients who receive palliative radiation therapy can be treated immediately after completion of radiation therapy
- •The patient has cardiac conditions as follows: uncontrolled hypertension (blood pressure \[BP\] \> 160/100) despite optimal therapy, uncontrolled angina, ventricular arrhythmias, congestive heart failure (New York Heart Association class II or above), baseline left ventricular ejection fraction (LVEF) =\< 50%, prior or current cardiomyopathy, atrial fibrillation with heart rate \> 100 beats per minute (bpm), unstable ischemic heart disease (myocardial infarction \[MI\] within 6 months prior to starting treatment or angina requiring use of nitrates more than once weekly)
- •The patient has peripheral neuropathy \>= grade 2
- •The patient is pregnant (confirmed by serum beta human chorionic gonadotropin \[b-HCG\], if applicable) or is breastfeeding
- •The patient has concurrent severe and/or uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes, severe infection requiring active treatment, severe malnutrition, chronic severe liver or renal disease)
- •The patient has refractory nausea and vomiting or chronic gastrointestinal diseases (e.g., inflammatory bowel disease) or has had significant bowel resection that would preclude adequate absorption (for oral therapy only)
- •The patient is unable to swallow capsules and/or has a surgical or anatomical condition that precludes swallowing and absorbing oral medication on an ongoing basis (for oral therapy only)
- •Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures
研究组 & 干预措施
Arm A: Targeted Therapy
Personalized treatment, targeted therapy against the alteration based on molecular profiling.
干预措施: Targeted Therapy Based on Molecular Profiling
Arm B: Standard-of-Care Therapy
Standard-of-Care treatment not selected on basis of alteration analysis.
干预措施: Standard-of-Care Therapy
结局指标
主要结局
Comparison of Progression-Free Survival (PFS) Between the Two Randomized Arms
时间窗: Continuous Monitoring, expected range from 2 months to 3 years
Progression-free survival (PFS) of patients treated with a targeted therapy selected on the basis of mutational analysis of the tumor compared with PFS of those whose treatment is not selected based on alteration analysis.