NL-OMON47273已完成不适用
An Open-label, Non-randomised, Multicentre Study to Allow Continued Access to and Assess the Safety and Tolerability of AZD1775 for Patients Enrolled in AZD1775 Clinical Pharmacology Studies - AZD1775 - Catch All
Astra Zeneca0 个研究点目标入组 14 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
- 14
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. Has read and understands the informed consent form (ICF) and has given written
- •informed consent prior to any study procedures.
- •2. Female or male aged *18 years.
- •3. Has completed 1 of the parent AZD1775 clinical pharmacology studies (ie,
- •D6014C00002, D6014C00003, D6014C00004, D6014C00005, or D6014C00006)
- •and in the Investigator*s opinion will continue to benefit from treatment with
- •AZD1775. Patients who discontinue early from the parent study will be considered
- •by the Sponsor and treating physician on a case-by-case basis.
- •4. Any prior radiation must have been completed at least 7 days prior to the start of
- •study treatment, and patients must have recovered from any acute effects prior to
- •the start of study treatment.
- •5. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 1.
- •6. Baseline laboratory values within 7 days of study treatment initiation in the CA
- •* 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 or *1.5 x ULN in patients with liver
- •metastases; or total bilirubin *3.0 x ULN with direct bilirubin within
- •normal limits 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) awhere F <= 0.85 for females and F <= 1 for males.
- •7. Female patients who are of non-childbearing potential and fertile women of
- •childbearing potential (WoCBP) who agree to use adequate contraceptive measures
- •that are in place during screening (or consent), for the duration of the study, and for
- •1 month after treatment stops; who are not breastfeeding; and who have a negative
- •serum or urine pregnancy test prior to the start of study treatment.
- •8. Male patients must be willing to use barrier contraception (ie, condoms) for the
- •duration of the study and for 3 months after study treatment discontinuation.
- •9. 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 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. Concurrent enrolment in another clinical study, unless it is an observational
- •(non-interventional) clinical study or the follow-up period of an interventional
- •4. Must not have received another systemic anti-cancer therapy in the interval
- •following participation in the AZD1775 clinical pharmacology study and the start
- •of treatment on the CA protocol.
- •5. Not developed any clinical findings suggestive of brain metastasis. Patients
- •continue to be neurological stable and remain off systemic corticosteroids following
- •treatment of known brain metastases.
- •6. Did not tolerate AZD1775 in the parent study in the opinion of the Investigator.
- •7. Where a course of palliative radiotherapy was indicated, the last fraction must have
- •been delivered before the start of study treatment on the CA study.
- •8. 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.
- •9. Grade >1 toxicities from prior therapy, according to the Common Terminology
- •Criteria for Adverse Events (CTCAE), excluding alopecia or anorexia.
- •10. Continue to be able to swallow oral medication, did not undergo placement of a
- •percutaneous endoscopic gastrostomy tube and did not require total parenteral
- •11. Has had prescription or non-prescription drugs or other products known to be
- •sensitive to CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic
- •index, or to be moderate to strong inhibitors/inducers of CYP3A4 between the
- •parent study and entry into this CA study. Co administration of aprepitant or
- •fosaprepitant during this study is prohibited.
- •12. Has consumed herbal preparations between the parent study and entry into this CA
- •13. Has consumed grapefruit, grapefruit juice, Seville oranges, Seville orange
- •marmalade, or other products containing grapefruit or Seville oranges between the
- •parent study and entry into the CA study.
- •14. Any known hypersensitivity or contraindication to AZD1775 or to the components
- •15. Any of the following cardiac diseases currently or within the last 6 months as
- •defined by the New York Heart Association *Class 2:
- •* Unstable angina pectoris.
- •* Congestive heart failure.
- •* Acute myocardial infarction.
- •* Conduction abnormality not controlled with pacemaker or medication.
- •* Significant ventricular or supraventricular arrhythmias (patients with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible).
- •16. AZD1775 should not be given to patients who have a history of Torsades de pointes
- •unless all risk factors that contributed to Torsades have been corrected. AZD1775
- •has not been studied in patients with ventricular arrhythmias or recent myocardial
- •infarction.
- •17. Patient with mean resting QTc interval (specifically QTc calculated using the
- •Fridericia formula [QTcF]) >450 ms for males and >470 ms for females from
- •3 electrocardiograms (ECGs) pe
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