- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01513733
The CATCH Prostate Cancer Trial: Cabazitaxel And Tasquinimod in Men With Prostate Cancer (CATCH)
2018년 8월 31일 업데이트: Andrew J. Armstrong, MD
The CATCH Prostate Cancer Trial: Cabazitaxel And Tasquinimod in Men With Castration-Resistant Heavily Pre-treated Prostate Cancer
The standard of care for men with metastatic CRPC in 2010 following progression on docetaxel is cabazitaxel or abiraterone acetate/prednisone.
Based on results from two other studies, cabazitaxel and prednisone has become a standard second line chemotherapy regimen and becomes the backbone upon which to improve upon.
Thus, the primary objective of this study is to determine the recommended dose of tasquinimod in combination with cabazitaxel and prednisone based on safety and tolerability in men with chemorefractory metastatic castration-resistant prostate cancer (CRPC).
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
25
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Illinois
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Chicago, Illinois, 미국, 60637
- The University of Chicago
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North Carolina
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Durham, North Carolina, 미국, 27710
- Duke Cancer Institute
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
남성
설명
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features;
- At least 18 years of age when signing the Informed Consent;
- Presence of metastatic disease on bone scan or CT/MRI imaging;
- Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., medical or surgical castration);
- For patients who have not had an orchiectomy, there must be a plan to maintain effective GnRH-analogue therapy for the duration of the trial;
- Serum testosterone level < 50 ng/dL at the Screening Visit;
- Progressive disease on or following docetaxel-based chemotherapy with medical or surgical castration. Patients who are intolerant of docetaxel are also allowed. Disease progression for study entry is defined as one or more of the following three criteria: 1) PSA progression defined by a minimum of three rising PSA levels with an interval of ≥ 1 week between each determination. The PSA value at the Screening visit should be ≥ 2 μg/L (2 ng/mL); 2) Soft tissue disease progression defined by RECIST 1.1; 3) Bone metastatic disease progression defined by one or more new lesions on bone scan that are not clinically consistent with tumor flare;
- No more than three prior chemotherapy regimens with at least one regimen containing docetaxel (unless intolerant as per # 7 above);
- Karnofsky Performance Status of >70;
- Estimated life expectancy of at least three months;
- Able to swallow the study drug and comply with study requirements;
- Willing and able to give informed consent.
Exclusion Criteria:
- Subjects > 80 years old (dose escalation phase only, due to lower clearance in elderly patients);
- Severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment;
- Metastases in the brain or active epidural disease (NOTE: patients with treated epidural disease are allowed provided follow up imaging documents stability of epidural disease);
- Absolute neutrophil count < 1,200/μL, platelet count < 100,000/μL, and hemoglobin <9 g/dL at the Screening Visit; (NOTE: patients may not have received any growth factors or blood transfusions within seven days of the hematologic laboratory values obtained at the Screening Visit)
- Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 times the upper limit of normal at the Screening Visit;
- Creatinine > 1.5 x ULN at the Screening visit;
- History of another malignancy within the previous 3 years other than non-melanomatous skin cancer or non-invasive bladder cancer treated with curative intent;
- Treatment with androgen receptor antagonists (bicalutamide, flutamide, nilutamide, MDV3100), 5-α reductase inhibitors (finasteride, dutasteride), estrogens (ie DES), sipuleucel-T, or chemotherapy within 28 days of Day 1 visit or plans to initiate treatment with any of these treatments during the study;
- Use of herbal products that may decrease PSA levels or systemic corticosteroids greater than the equivalent of 10 mg of prednisone/prednisolone per day within four weeks of Day 1 visit;
- Ongoing treatment with warfarin unless the international normalized ratio (INR) is well controlled and below 4
- Exposure to ketoconazole or other strong CYP3A4 inhibitors or inducers intravenously or orally within 28 days prior to Day 1 Visit. For abiraterone acetate or TAK700, 14 days washout is needed.
- Ongoing treatment with sensitive CYP1A2 substrates or CYP1A2 substrates with narrow therapeutic range (Appendix 3).
- Ongoing treatment with CYP3A4 substrates with narrow therapeutic range (Appendix 3).
- Radiation therapy within 2 weeks (if single fraction of radiotherapy within 2 weeks) and radionuclide therapy within 8 weeks of Day 1 visit;
- Planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery;
- Structurally unstable bone lesions suggesting impending fracture;
- Clinically significant cardiovascular disease including:myocardial infarction within 6 months, uncontrolled angina within 3 months, congestive heart failure, Diagnosed or suspected congenital long QT syndrome; significant ventricular arrhythmias, Prolonged corrected QT interval by the Fridericia or Bazett correction formula, History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place; Hypotension (systolic blood pressure < 86 mMHg or bradycardia with a heart rate < 50 beats per minute on any ECG taken at the Screening or Day 1 visit; Uncontrolled hypertension; TIA or stroke/CVA within 6 months of Day 1 visit; Rest limb claudication or ischemia within 6 months of Day 1 visit
- Use of an investigational agent within four weeks of Day 1 visit or plans to initiate treatment with an investigational agent during the study;
- Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within last three months);
- Major surgery within four weeks prior to Day 1 visit.
- Presence of NCI CTC grade >1 peripheral neuropathy
- History of pancreatitis
- Known positive serology for HIV (patients with known history of HIV will be excluded because of potential for unforeseen toxicity and morbidity in an immunocompromised host).
- Chronic hepatitis B or C with advanced, decompensated hepatic disease, or cirrhosis of the liver or history of a chronic viral hepatitis or known viral hepatitis carrier (patients recovered from hepatitis will be allowed to enter the study).
- Documented prior disease progression on tasquinimod -
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Tasquinimod single dose
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tasquinimod 0.25 mg continuously
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실험적: tasquinimod 0.25 mg followed by 0.5 mg
tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg continuously, if tolerated
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tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg continuously, if tolerated
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실험적: tasquinimod 0.25 mg; 0.5 mg; 1.0 mg
tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg for 3 weeks followed by 1.0 mg continuously, if tolerated
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tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg for 3 weeks followed by 1.0 mg continuously, if tolerated
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number of participants who experience dose limiting toxicities at the highest titrated dose for each dose level
기간: 6 weeks
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The primary objective is to determine the recommended dose of tasquinimod in combination with cabazitaxel and prednisone based on safety and tolerability in men with chemorefractory metastatic castration-resistant prostate cancer (CRPC).
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6 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Evaluation of progression free survival
기간: Every 9 weeks
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Preliminary evidence of durable efficacy will be based on a modified PCWG2-defined radiologic progression-free survival including RECIST 1.1 criteria (PFS).
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Every 9 weeks
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Evaluation of overall response
기간: Every 9 weeks
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Radiologic response criteria using RECIST 1.1 (overall response)
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Every 9 weeks
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Preliminary evidence of response efficacy as measured by the rates of PSA decline (waterfall plot) and benchmarks of reaching a >30% decline within 3 months, a PSA decline >50% and >90%, and PSA normalization. Duration of PSA responses will be measured
기간: Every 3 weeks
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Every 3 weeks
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Favorable changes in circulating tumor cell number (5 or greater to less than 5) and proportion of men who achieve a reduction in CTC count
기간: Every 3 weeks
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Every 3 weeks
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Number and percent of participants that are alive
기간: 2 years
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Overall survival
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2 years
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Detailed characterization of all NCI CTC v4.0 toxicities over time (per cycle)
기간: Every 3 weeks
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Detailed characterization of all NCI CTC v4.0 toxicities over time (per cycle)
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Every 3 weeks
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The concentration of tasquinimod and cabazitaxel in blood plasma
기간: 12 weeks
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Pharmacokinetic analysis of tasquinimod and cabazitaxel (cycle 1-4 only)
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12 weeks
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Pain response, as measured by percentage of patients with a reduction of at least 2 points on the visual analog scale despite a stable pain regimen. Pain scores over time will be described in an exploratory fashion.
기간: Every 3 weeks
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Every 3 weeks
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Changes in bone alkaline phosphatase and LDH over time
기간: Every 3 weeks
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Descriptive statistics will be used to summarize laboratory variables
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Every 3 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Andrew Armstrong, MD, Duke Cancer Institute
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
유용한 링크
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2012년 1월 1일
기본 완료 (실제)
2015년 6월 1일
연구 완료 (실제)
2016년 6월 1일
연구 등록 날짜
최초 제출
2012년 1월 17일
QC 기준을 충족하는 최초 제출
2012년 1월 17일
처음 게시됨 (추정)
2012년 1월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 9월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 8월 31일
마지막으로 확인됨
2018년 8월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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