ISRCTN12839469已完成1 期
A Phase I, open-label, non-randomized study to characterize the impact of dietary modification on inavolisib associated hyperglycemia and to assess the CYP3A4 induction potential of inavolisib using midazolam as a probe substrate in patients with incurable metastatic solid tumors previously treated with multiple (=2) lines of therapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Participants must be at least 18 years of age at time of signing Informed Consent Form
- •2. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs
- •3. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm
- •4. Incurable metastatic phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)-wild type or PIK3CA-mutated solid tumours previously treated with multiple (=2) lines of therapy
- •5. For Arm A of the study: non-obese, non-diabetic participants with BMI <30 kilogram per square metre (kg/m²), fasting blood sugar (FBG) <126 milligram per decilitre (mg/dL) (7.0 mmol/L) and glycated haemoglobin (HbA1C) <5.7% at screening
- •6. For Arm B1 and Arm B2 of the study: Obese participants and/or prediabetic participants with BMI =30 kg/m², FBG 126-140 mg/dL (7.0-7.8 mmol/L) and HbA1C between 5.7% and <7% at screening
- •7. Eastern Cooperative Oncology Group (ECOG) performance status =2
- •8. Life expectancy of =12 weeks
- •9. Adequate hematologic and organ function within 14 days prior to initiation of study treatment
- •10. Ability, in the investigator’s judgment, and willingness to comply with all study-related procedures
排除标准
- •1. Any history of leptomeningeal disease or carcinomatous meningitis
- •2. Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
- •3. Prior treatment with any phosphatidylinositol 3-kinase (PI3K), protein kinase B (AKT), or mammalian target of rapamycin (mTOR) inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway
- •4. Inability or unwillingness to swallow pills
- •5. Malabsorption syndrome or other condition that would interfere with enteral absorption
- •6. Known and untreated, or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Participants with a history of treated CNS metastases are eligible with few criteria
- •7. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures once per 2 weeks or more frequently
- •8. Serious infection requiring IV (intravenous) antibiotics within 14 days prior to Day 1 of Cycle 1
- •9. Any concurrent ocular or intraocular condition (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition
- •10. Active inflammatory (e.g., uveitis or vitritis) or infectious (e.g., conjunctivitis, keratitis, scleritis, or endophthalmitis) conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
- •11. Participants requiring any daily supplemental oxygen
- •12. Symptomatic active lung disease, including pneumonitis
- •13. History of or active gastrointestinal inflammatory disease (e.g., Crohn’s disease or ulcerative colitis) or any active bowel inflammation (including diverticulitis)
- •14. Symptomatic hypercalcemia requiring continued use of bisphosphonate or denosumab therapy
- •15. Clinically significant and active liver disease, including severe liver impairment (Child-Pugh Class B/C), viral or other hepatitis, current alcohol abuse, or cirrhosis
- •16. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness
- •17. Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, metabolic, or infectious disease) or any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or that renders the participant at high risk from treatment complications
- •18. Major surgical procedure, or significant traumatic injury, within 4 weeks prior to initiation of study treatment or anticipation of the need for major surgery during study treatment
- •19. Minor surgical procedures <7 days prior to initiation of study treatment
- •20. Chemotherapy within 2 weeks or 5 half-lives, whichever is longer, prior to initiation of study treatment. Radiotherapy, or any other anti-cancer therapy within 2 weeks prior to initiation of study treatment
- •21. Investigational drug(s) within 4 weeks before initiation of study treatment
- •22. Unresolved toxicity from prior therapy, except for hot flashes, alopecia, and Grade <2 peripheral neuropathy
- •23. History of other malignancy within 5 years prior to screening with few exceptions
- •24. History of or active
研究者
相似试验
未知
1 期
A Phase I, Open-label, Non-randomized Study, to Assess the Safety and Tolerability of Cediranib (AZD2171) in Combination With Cisplatin Plus a Fluoropyrimidine (Capecitabine or S-1) in Japanese Patients With Previously Untreated Locally Advanced or Metastatic Unresectable Gastric CancerGastric CancerJPRN-jRCT2080220881AstraZeneca
招募中
不适用
A Phase I, Open-label, Non-randomised Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of a Single Oral Dose of AZD9291 in Patients with EGFRm Positive NSCLC Whose Disease has Progressed on an EGFR TKIProgressive Non Small Cel Lung Cancer with positive epidermal growth factor receptor10038666NL-OMON45155Astra Zeneca5
进行中（未招募）
1 期
Study that tested S64315 plus different standard treatments in patients with breast cancerEUCTR2019-000998-23-ESInstitut de Recherches Internationales Servier
已完成
不适用
A Randomised, Open-label, Phase I Study to Determine the Effect of Food on the pharmacokinetics of AZD1775 After Oral Dosing of a Capsule Formulation in Patients with Advanced Solid Tumours.Solid Tumour10027655CancerNL-OMON46295Astra Zeneca7
已完成
1 期
A Phase I, Randomised, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Doses of ATL1102 Alone and in Combination with G-CSF in Healthy VolunteersStem cell mobilisationBlood - Haematological diseasesACTRN12614000200684Antisense Therapeutics10