- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02121639
Open Label Phase I/Randomised,Double Blind Phase II Study in mCRPC of AZD5363 In Combination With DP Chemotherapy (ProCAID)
An Open Label Phase I/Randomised, Double Blind Phase II Study in Metastatic Castration Resistant Prostate Cancer of AZD5363 In Combination With Docetaxel and Prednisolone Chemotherapy (ProCAID)
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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Hampshire
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Southampton, Hampshire, 영국, SO16 6YD
- Southampton General Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Histologically or cytologically proven mCRPC with documented metastases (measurable or evaluable disease is acceptable) now eligible for treatment with docetaxel chemotherapy
Disease progression since the last change in therapy defined by one or more of the following according to the Prostate Cancer Working Group (PCWG2) criteria (J Clin Oncol 2008;26:1148-1159):
i. PSA progression as defined by the prostate cancer working group (2) (PCWG2) criteria (Scher et al. 2008 J Clin Oncol. 26; 1148). This must be based on a series of at least 3 readings at least 7 days apart. The 3rd reading must be >= 2ng/ml. In the event where an intermediate reading is lower than a previous reading, then the patient will still be eligible (ie. the 3 readings do not need to be consecutive). The first of the three readings must have been obtained after commencing the previous systemic therapy, or, in the case of androgen receptor antagonists, after discontinuing.
ii. Radiographic progression of nodal or visceral metastases as defined by RECIST version 1.1 (Eur J Cancer 2009;45:228). See Appendix 5 iii. The appearance of two or more new bony metastases
- Serum testosterone <1.7 nmol/L (ongoing LHRH analogue or antagonist therapy is permitted to maintain a castrate state)
- Discontinuation of prior therapies for prostate cancer ≥ 4 weeks prior to commencing study treatment (with the exception of an LHRH agonist or antagonist where required for ongoing testosterone suppression)
- No current anti-androgen withdrawal response from bicalutamide or flutamide. Consistent with PCWG2 guidelines, investigators should evaluate patients to exclude withdrawal response for 6 weeks after stopping bicalutamide or flutamide. Investigators need not wait to assess for withdrawal response in patients who did not respond, or who showed a PSA decline for ≤ 3 months, after bicalutamide or flutamide was administered as a second-line or later intervention.
- ECOG performance status 0 or 1
- Hb ≥ 9g/dL; platelets ≥ 100 x 109/L; neutrophils ≥ 1.5 x109/L
- Bilirubin ≤ ULN ; ALT and AST ≤ 1.5 x ULN
- Sodium and potassium within the normal range for the site
- Able to swallow study drugs (without crushing/opening in the case of AZD5363)
- Life expectancy > 3 months
- Aged 18 years or over
- Provision of written informed consent
Exclusion Criteria:
- Previous treatment with cytotoxic chemotherapy for castrate resistant prostate cancer. Patients may have received previous docetaxel for up to 6 cycles given in the 'hormone sensitive setting' or ongoing bisphosphonates or denosumab. There are no restrictions on prior use of second generation hormonal therapies e.g. abiraterone, enzalutamide as long as they have been discontinued ≥ 2 weeks prior to commencing study treatment.
- Prior malignancy with an estimated ≥ 30% chance of relapse within 2 years following curative treatment
- Previously identified brain metastases, or spinal cord compression unless treated with full functional recovery
- Prior radiotherapy to > 30% of bone marrow
- Administration of an investigational agent within 30 days of first dose of study medication
Patients will be excluded with any of:
i. Diabetes mellitus type I ii. Fasting plasma glucose [fasting is defined as no calorific intake for at least 8 hours] of either ≥ 7.0mmol/L (126 mg/dL) for those patients without a pre-existing diagnosis of Type 2 diabetes mellitus or ≥ 9.3 mmol/L (167mg/dL) for those patients with a pre-existing diagnosis of Type 2 diabetes mellitus iii. Glycosylated haemoglobin (HbA1C) ≥8.0% (63.9 mmol/mol) iv. Requirement for insulin for routine diabetic management and control v. Requirement for more than two oral hypoglycaemic medications for routine diabetic management and control.
- Malabsorption syndrome, previous gastrointestinal surgery, or other gastrointestinal condition that may affect drug absorption
- Coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris or congestive heart failure (NYHA ≥ grade 2) within the last 6 months
- Abnormal echocardiogram or MUGA (LVEF should be normal according to the criteria used within the treating institution
- Uncontrolled hypotension (systolic blood pressure <90 mmHg and/or diastolic blood pressure <50 mmHg)
- QTc interval of >480 msec at two or more time points within a 24 hour period
- Proteinuria (either 3+ on dipstick analysis or >500 mg/24 hours) or creatinine >1.5 x ULN concurrent with creatinine clearance <50 mL/min (assessed as per local practice e.g. by Cockcroft and Gault estimation)
- Exposure to potent inhibitors or inducers of CYP3A4 or CYP2D6 or substrates of CYP3A4 within 2 weeks before the first dose of study treatment (3 weeks for St John's Wort)
- Unresolved toxicity ≥ grade 2 (except alopecia) from previous cancer therapy
- Patients with a partner of child-bearing potential who are not using a highly effective method of contraception, who are unwilling to use condoms during the study and for 30 days after the last dose of study drug
- Known hypersensitivity to AZD5363, its excipients, or drugs in its class
Previous exposure to agents with the following mechanisms of action:
- inhibition of AKT (e.g., MK2206, GDC0068, GSK2110183, GSK2141795)any inhibitor with PI3K pharmacology (e.g., GDC0941, XL147, BKM120, PX866, BYL719, AMG319, GDC0032, INK1117, INK119)
- any compound with mixed PI3K and mammalian target of rapamycin (mTOR) kinase pharmacology (e.g., BEZ235, GDC0980, PF04691502, PF05212384, GSK2126458, XL765)
- or any mTOR kinase inhibitor (e.g., AZD8055, AZD2014, OSI027, INK128) Note: Do not exclude patients previously treated with a rapalogue (allosteric inhibitor of mTOR; mTORC1 complex inhibitor) - including temisirolimus (Torisel; Pfizer), everolimus (Affinitor; Novartis), ridoforolimus (Ariad).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: 위약
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실험적: AZD5363
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Phase I:Determination of a suitable dose of AZD5363
기간: Up to 18 months
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Phase I:Determination of a suitable dose of AZD5363 using a 4 days on/3 days off continuous schedule, in combination with Docetaxol and prednisolone chemotherapy
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Up to 18 months
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Phase II: Progression free survival
기간: 5 years
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Phase II: Progression free survival (PFS) in patients receiving AZD5363 versus placebo when combined with Docetaxol and prednisolone chemotherapy (DP) in metastic castration resistant prostate cancer (mCRPC)
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5 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Phase I: Safety and tolerability profiles
기간: Up to 18 months
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Phase I: Safety and tolerability profiles using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
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Up to 18 months
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Phase I: AZD5363 pharmacokinetics Area Under Curve (AUC) Time Frame: predose, 2, 4, 8, 24,144 hours post-dose
기간: Up to 18 months
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Phase I: AZD5363 pharmacokinetics in combination with Docetaxol and prednisolone chemotherapy
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Up to 18 months
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Phase II: Bone Pain
기간: 5 years
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Phase II: Bone pain changes using the brief pain inventory
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5 years
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Phase II: Progression Free Survival
기간: 5 years
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Phase II: Progression Free Survival excluding biochemical (Prostate Specific Antigen - PSA) alone progression
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5 years
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Phase II: Biochemical (PSA) response rates according to PCWG2 criteria
기간: 5 years
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Phase II: Biochemical (Prostate Specific Antigen - PSA) response rates according to Prostate Cancer Working Gourp (PCWG2) criteria
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5 years
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Phase II: Safety and tolerability profiles using CTCAE version 4.03
기간: 5 years
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Phase II: Safety and tolerability profiles using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
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5 years
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Crabb SJ, Griffiths G, Marwood E, Dunkley D, Downs N, Martin K, Light M, Northey J, Wilding S, Whitehead A, Shaw E, Birtle AJ, Bahl A, Elliott T, Westbury C, Sundar S, Robinson A, Jagdev S, Kumar S, Rooney C, Salinas-Souza C, Stephens C, Khoo V, Jones RJ. Pan-AKT Inhibitor Capivasertib With Docetaxel and Prednisolone in Metastatic Castration-Resistant Prostate Cancer: A Randomized, Placebo-Controlled Phase II Trial (ProCAID). J Clin Oncol. 2021 Jan 20;39(3):190-201. doi: 10.1200/JCO.20.01576. Epub 2020 Dec 16.
- Crabb SJ, Birtle AJ, Martin K, Downs N, Ratcliffe I, Maishman T, Ellis M, Griffiths G, Thompson S, Ksiazek L, Khoo V, Jones RJ. ProCAID: a phase I clinical trial to combine the AKT inhibitor AZD5363 with docetaxel and prednisolone chemotherapy for metastatic castration resistant prostate cancer. Invest New Drugs. 2017 Oct;35(5):599-607. doi: 10.1007/s10637-017-0433-4. Epub 2017 Feb 1.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- RHMCAN0935
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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