NL-OMON46295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. - AZD1775 - Food effect
Astra Zeneca0 个研究点目标入组 7 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
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
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Read and understand the informed consent form (ICF) and given written informed
- •consent prior to any study procedures.
- •2. Histologically or cytologically documented, locally advanced or metastatic solid
- •tumour, excluding lymphoma, for which standard therapy does not exist or has
- •proven ineffective or intolerable.
- •3. Any prior palliative radiation must have been completed at least 7 days prior to the
- •start of study treatment, and patients must have recovered from any acute adverse
- •effects prior to the start of study treatment.
- •4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of
- •5. Baseline laboratory values within 7 days of study treatment initiation:
- •* Absolute neutrophil count (ANC) *1500/*L.
- •* Haemoglobin *9 g/dL.
- •* Platelets *100,000/*L.
- •* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
- •*3 x upper limit of normal (ULN) or *5 x ULN if known hepatic metastases.
- •* Serum bilirubin within normal limits (WNL) or *1.5 x ULN in patients with
- •liver metastases; or total bilirubin *3.0 x ULN with direct bilirubin WNL in
- •patients with well documented Gilbert*s Syndrome.
- •* Serum creatinine *1.5 x ULN, or measured creatinine clearance (CrCl)
- •calculated by Cockcroft-Gault method *45 mL/min (confirmation of creatinine
- •clearance is only required when creatinine is >1.5 x ULN)
- •(CrCl (glomerular filtration rate) <= (140-age) x (weight/kg) x Fa) /
- •(72 x serum creatinine mg/dL) -where F <= 0.85 for females and F <= 1 for males
- •6. Female patients who are not of childbearing potential and fertile females of
- •childbearing potential who agree to use adequate contraceptive measures that are in
- •during screening (or consent), for the duration of the study, and for 1 month after
- •treatment stops, and who are not breastfeeding, and who have a negative serum or
- •urine pregnancy test prior to the start of study treatment.
- •7. Male patients should be willing to use barrier contraception (ie, condoms) for the
- •duration of the study and for 3 months after study treatment discontinuation.
- •8. Female or male patients *18 years.
- •9. Patient should be able to adequately consume a high-fat meal as prescribed in
- •Treatment B.
- •10. Willingness and ability to comply with the study and the follow-up procedures.
排除标准
- •1. Involvement in the planning and/or conduct of the study (applies to both
- •AstraZeneca personnel and/or personnel at the study centre).
- •2. Previous enrolment or randomisation and received study treatment in the present
- •study. Patients can, however, be re-screened if the reason for the screen failure no
- •longer exists.
- •3. Known malignant central nervous system (CNS) disease other than neurologically
- •stable, treated brain metastases * defined as metastasis having no evidence of
- •progression or haemorrhage for at least 2 weeks after treatment (including brain
- •radiotherapy). Must be off any systemic corticosteroids for the treatment of brain
- •metastases for at least 14 days prior to enrolment.
- •4. Use of any anti-cancer treatment drug *21 days or 5 half-lives (whichever is
- •shorter) prior to the first administration of AZD1775. For drugs for which
- •5 half-lives is *21 days, a minimum of 10 days between termination of the prior
- •treatment and administration of AZD1775 treatment is required.
- •5. No other anticancer-therapy (chemotherapy, immunotherapy, hormonal anti-cancer
- •therapy, radiotherapy [except for palliative local radiotherapy]), biological therapy
- •or other novel agent is to be permitted while patient is receiving study treatment.
- •Patients on LHRH analogue treatment for more than 6 months are allowed entry
- •into the study and may continue at the discretion of the Investigator.
- •6. Patients suffering from conditions which are likely to adversely affect
- •gastrointestinal motility and/or transit (for example, diarrhoea, vomiting or nausea,
- •gastroparesis, irritable bowel syndrome and malabsorption) or patients with
- •gastrointestinal resection (eg, partial or total gastrectomy) likely to interfere with
- •absorption of study treatment.
- •7. Major surgical procedures *28 days of beginning study treatment, or minor surgical
- •procedures *7 days. No waiting period required following port-a-cath placement or
- •other central venous access placement.
- •8. Grade >1 toxicities from prior therapy, according to the Common Terminology
- •Criteria for Adverse Events (CTCAE), excluding alopecia or anorexia.
- •9. Patient has an inability to swallow oral medications. Note: Patient may not have a
- •percutaneous endoscopic gastrostomy tube or be receiving total parenteral nutrition.
- •10. Patients who are not non-smokers or light smokers (no more than 5 cigarettes per
- •day) and who cannot abstain from smoking from 2 weeks prior to the first
- •administration of AZD1775 until after the last PK sample collection in Period 2.
- •11. Any intake of grapefruit, grapefruit juice, Seville oranges, Seville orange
- •marmalade, or other products containing grapefruit or Seville oranges within 7 days
- •of the first administration of AZD1775.
- •12. Patient has had prescription or non-prescription drugs or other products known to be
- •sensitive to cytochrome P450 (CYP)3A4 substrates or CYP3A4 substrates with a
- •narrow therapeutic index, or to be moderate to strong inhibitors/inducers of
- •CYP3A4 which cannot be discontinued 2 weeks prior to Day 1 of dosing and
- •withheld throughout the study until 2 weeks after the last administration of
- •AZD1775. Co-administration of aprepitant or fosaprepitant during this study is
- •prohibited.
- •13. Patient has had adjustments to prescription or non-prescription drugs or other
- •products known to be weak inhib
研究者
相似试验
已完成
1 期
A study to characterize the impact of dietary modification on inavolisib associated hyperglycaemia and to assess the CYP3A4 induction potential of inavolisib using midazolam as a probe substrate in participants with incurable metastatic solid tumours previously treated with multiple (=2) lines of therapyMetastatic solid tumoursCancerISRCTN12839469F. Hoffmann-La Roche Ltd3
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
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
进行中（未招募）
1 期
An Open Label, Randomized Phase I/IIa Trial Evaluating MK-0646 in Combination With Erlotinib (TARCEVA™) for Patients With Recurrent Non-Small Cell Lung Canceron-small cell lung cancerMedDRA version: 9.1 Level: LLT Classification code 10061873 Term: Non-small cell lung cancerEUCTR2007-005941-39-GBMerck & Co Inc95
进行中（未招募）
不适用
An Open Label, Randomized Phase I/IIa Trial Evaluating MK-0646 in Combination With Erlotinib (TARCEVA™) for Patients With Recurrent Non-Small Cell Lung CancerEUCTR2007-005941-39-ATMerck Sharp & Dohme GmbH68