- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00513071
AZD0530 in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
A Phase II Trial of AZD0530 in Hormone Refractory Prostate Cancer (HRPC)
연구 개요
상세 설명
PRIMARY OBJECTIVES:
I. To test the hypothesis that AZD0530 will improve the prostate-specific antigen (PSA) response rate and progression-free survival (PFS) in comparison with historical controls for patients with hormone-refractory prostate cancer (HRPC).
II. Evaluate the time to treatment failure and overall survival of patients with HRPC treated with AZD0530.
III. Evaluate the toxicities and tolerance of AZD0530 therapy in the HRPC population.
OUTLINE: This is a multicenter study.
Patients receive oral AZD0530 once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months for the first 2 years and then yearly thereafter.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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California
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Duarte, California, 미국, 91010
- City of Hope
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Histologically or cytologically confirmed prostate cancer with a Gleason score available or interpretable and meeting 1 of the following criteria:
- No prior chemotherapy and relatively minimal cancer spread
- Only one prior taxane-based chemotherapy for aggressive and/or symptomatic disease
Must have prostate cancer considered to be hormone refractory or androgen independent by one or more of the following criteria (despite androgen deprivation and anti-androgen withdrawal when applicable):
- Progression of unidimensionally measurable disease assessed within 28 days prior to initial administration of drug
- Progression of evaluable but not measurable disease assessed within 28 days prior to initial administration of drug for PSA evaluation and within 42 days for imaging studies (e.g., bone scans)
Patients must have nonmeasurable disease (e.g., nuclear medicine bone scans) and non-target lesions (e.g., PSA level) assessed within 28 days prior to initial administration of drug
- Measurable disease is not required but is allowed
Must be surgically or medically castrated
- If the method of castration was luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide or goserelin), then the patient must be willing to continue the use of LHRH agonists
- Serum testosterone must be at castrate levels (< 50 ng/dL) at least 3 months prior to registration
- ECOG performance status 0-2
- WBC >= 3,000/uL
- Absolute neutrophil count >= 1,500/uL
- Platelets >= 100,000/uL
- Hemoglobin > 9 g/d
- Total bilirubin within normal institutional limits
- AST/ALT =< 2.5 x institutional upper limit of normal
- Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min
- Must agree to use adequate contraception prior to study entry and for the duration of study participation
- At least 3 weeks since the completion of chemotherapy and radiotherapy and the patient must have recovered from the side effects of the therapy
- At least 28 days since prior non-steroidal anti-androgens (e.g., flutamide) (42 days for bicalutamide or nilutamide) or hormonal treatment (e.g., ketoconazole) and demonstrated progression of disease since the agents were suspended
- Concurrent bisphosphonate therapy is allowed
Exclusion Criteria:
- Known brain metastases
- History of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530
Patients with any of the following conditions that impair the ability to swallow AZD0530 tablets
- Gastrointestinal tract disease resulting in an inability to take oral medication or requiring IV alimentation
- Prior surgical procedures affecting absorption
- Active peptic ulcer disease
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
- Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier
Use of specifically prohibited CYP3A4-active agents or substances
- Prohibited drugs should be discontinued 7 days prior to the administration of the first dose of AZD0530 and for 7 days following discontinuation of AZD0530
- Patients receiving any other investigational agents
- No investigational or commercial agents or therapies other than study drugs may be administered with the intent to treat the patient's malignancy
- HIV-positive patients on combination antiretroviral therapy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Treatment (saracatinib)
Patients receive oral AZD0530 once daily.
Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
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상관 연구
구두로 주어진
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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PSA Response Rate
기간: PSA measured every 4 weeks
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Complete Response (CR), disappearance of all measurable and non-measurable disease.
No new lesions.
PSA ≤ 0.2 ng/mL; Partial Response (PR), a decline in PSA by at least 30%, confirmed by a second PSA value four or more weeks later; Overall Response (OR) = CR + PR
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PSA measured every 4 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Progression-free Survival (PFS)
기간: From start of treatment until progression or death, up to 2 years
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PFS defined as time between start of treatment and disease progression or death.
Using the method of Kaplan-Meier.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
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From start of treatment until progression or death, up to 2 years
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Time to Treatment Failure
기간: From first day of treatment until discontinuation of treatment, up to 2 years
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Defined as the time from start of treatment to the discontinuation of treatment for any reason, including disease progression, treatment toxicity, patient preference, or death Will be summarized using the Kaplan-Meier product-limit estimators.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
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From first day of treatment until discontinuation of treatment, up to 2 years
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Overall Survival
기간: From start of treatment, up to 5 years
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Estimated using the product-limit method of Kaplan and Meier.
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From start of treatment, up to 5 years
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Toxicity Data
기간: Up to 2 years
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Toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
All grade 3 or worse toxicities (Possibly, Probably, or Definitely) attributed to AZD0530.
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Up to 2 years
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Relationship Between Changes in Laboratory Correlates and Response and Survival
기간: Up to 2 years
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Up to 2 years
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N-telopeptide and Deoxypyridinoline as Prognostic Bone Markers
기간: At baseline, at 6 hours, at each course (day 1), and at 2 years
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At baseline, at 6 hours, at each course (day 1), and at 2 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Primo Lara, City of Hope Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- NCI-2012-02842
- N01CM62201 (미국 NIH 보조금/계약)
- PHII-79
- N01CM62209 (미국 NIH 보조금/계약)
- CDR0000559142 (레지스트리 식별자: PDQ (Physician Data Query))
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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