EUCTR2015-003656-40-GB进行中（未招募）1 期
A Phase 1b/2 Study of Ibrutinib Combination Therapy in Selected Advanced Gastrointestinal And Genitourinary Tumors - PCYC-1128-CA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 308
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. Histologically confirmed:
- •- RCC (clear cell)
- •- Urothelial carcinoma (transitional cell)
- •- Gastric or GEJ adenocarcinoma
- •- K-RAS or N-RAS wild-type EGFR expressing CRC
- •2. One or more measurable lesions per RECIST 1.1 criteria.
- •3. The following prior criteria should be followed:
- •- Metastatic RCC: minimum of 1 and maximum of 4 prior regimens, one or more of which must have included a VEGF-TKI
- •Advanced (locally recurrant and or metastatic) UC: minimum of 1 andmaximum of 2 prior regimens, one of which must have included a platinum based regimen (cohort 2) or a checkpoint inhibitor (cohort 5)
- •-Advanced (locally recurrent and/or metastatic) urothelial carcinoma: minimum of 1 and maximum of 2 prior regimens, one of which must be a platinum based regimen
- •- Advanced (locally recurrent and or metastatic) gastric or GEJ adenocarcinoma: minimum of 1 and maximum of 3 prior regimens one of which must be a fluoropyrimidine based regimen
- •- Metastatic CRC: minimum of 2 and maximum of 4 prior regimens, which must have included both an irinotecan and an oxaliplatin based regimen or unable to tolerate irinotecan chemotherapy
- •4. Each subject must be assessed by the investigator to be a suitable candidate for treatment with everolimus, docetaxel, paclitaxel, cetuximab or ibrutinib monotherapy, as appropriate according to their type of cancer
- •5. Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 3 days of the first dose of study drug. Female subjects who are of non-reproductive potential (ie, post-menopausal by history - no menses for =1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy) are exempt from this criterion
- •6. Male and female subjects of reproductive potential must agree to perform complete abstinence1 or to use both, a highly effective method of birth control (implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], or sterilized partner) and a barrier method (eg, condoms, cervical rings, cervical condoms, sponge) during the period of therapy and for 90 days after the last dose of ibrutinib, everolimus, docetaxel, and paclitaxel; 6 months after the last dose of cetuximab (6 months for all study drugs in UK only)
- •7. Adequate hematologic function independent of platelet transfusion and growth factor support for at least 7 days prior to enrollment, with the exception of pegylated G-CSF (granulocyte-colony stimulating factor pegfilgrastim) and darbopoeitin which requires at least 14 days, defined as:
- •- Absolute neutrophil count >1500 cells/mm3 (1.5 x 10 9/L)
- •- Platelet count >80,000 cells/mm3 (80 x 10 9/L) for cohorts 1 (RCC)
- •- Platelet counts >100,000 cells/mm3 (100 x 10 9/L) for cohorts 2 (urothelial carcinoma) and 3 (gastric adenocarcinoma) and 4 (CRC)
- •- Hemoglobin =8.0 g/dL for cohorts 1 (RCC), 2 (urothelial carcinoma), and 3 (gastric adenocarcinoma) • Hemoglobin =9.0 g/dL for cohort 4 (CRC)
- •8. Adequate hepatic and renal function defined as:
- •- Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) =5.0 x upper limit of norma
排除标准
- •Disease-Related
- •1. Anticancer therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 28 days of the first dose of study drug (4 weeks for nitrosureas, mitomycin C, or antibody based therapies)
- •2. Prior treatment with: ?
- •- Everolimus or temsirolimus (RCC cohort)
- •- Any taxane (urothelial carcinoma cohort 2)
- •- Any taxane (gastric adenocarcinoma cohort) ?
- •- Cetuximab or panitumumab (CRC cohort)
- •3. Prior radiotherapy to measurable lesion, unless documented
- •progression has occurred post-irradiation
- •4. Lack of recovery from previous therapeutic radiation (persistence of Grade =2 radiation-related toxicity) or planned radiation therapy during the study period
- •Concurrent Conditions
- •5. Any uncontrolled active systemic infection including any infection requiring systemic IV treatment which was completed =7 days before Cycle 1 Day 1
- •6. History of other malignancies, except: ?
- •- Malignancy treated with curative intent and with no known active
- •- disease present for =3 years before the first dose of study drug and felt to be at low risk for recurrence by investigator
- •- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- •- Adequately treated carcinoma in situ without current evidence of disease
- •7. Prior treatment with ibrutinib or other BTK inhibitor 8. ALT and/or AST >1.5 x ULN and alkaline phosphatase >2.5 x ULN (gastric adenocarcinoma cohort only)
- •9. Known allergy or hypersensitivity to ibrutinib or any other component of combination therapy, including polysorbate 80 or Cremophor® EL (polyoxyethylated castor oil)
- •10. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE) version 4.03, grade 0 or 1 11. Known bleeding disorders (eg, von Willebrand’s disease) or hemophilia
- •12. Grade =3 sensory peripheral neuropathy
- •13. History of stroke or intracranial hemorrhage within 6 months prior to enrollment
- •14. Known brain or leptomeningeal disease (CT or MRI scan of the brain required only in case of clinical suspicion of central nervous system involvement)
- •15. Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV) Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded.
- •16. Major surgery within 4 weeks of first dose of study drug
- •17. Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk
- •18. Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure, as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute c
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