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Ph I Dasatinib + Erlotinib in Recurrent MG

2014년 7월 15일 업데이트: Duke University

Phase I Study of Dasatinib Plus Erlotinib in Recurrent Malignant Glioma

Primary:

To determine maximum tolerated dose & dose limiting toxicity of dasatinib when combined w erlotinib among pts w recurrent MG

Secondary:

To further evaluate safety & tolerability of dasatinib + erlotinib To evaluate pharmacokinetics of dasatinib when administered w erlotinib among recurrent MG pts who are on & not on CYP-3A enzyme inducing anti-epileptic drugs To evaluate for anti-tumor activity with this regimen in this patient population

연구 개요

상태

완전한

상세 설명

Tarceva administered on continuous oral dosing schedule at 150 mg/day for pts not on EIAEDs & 450 mg/day for pts on EIAEDs. Starting dose level of dasatinib will be 100 mg once day via continuous oral daily dosing. Dasatinib will be increased in successive cohorts of enrolled pts. Pts will remain on treatment until excessive toxicity, progressive disease, withdrawal of consent/death.

Pts have confirmed diagnosis of recurrent/progressive WHO gr IV MG / WHO grade III MG. Phase I 3+3 dose escalation design w 2 independently escalated stratum: stratum A-pts not on CYP3A-enzyme inducing anti-epileptic drugs; stratum B-pts on EIAEDs. Assessment of safety will be based mainly on frequency of adverse events, particularly adverse events leading to discontinuation of treatment & on number of significant lab abnormalities.

연구 유형

중재적

등록 (실제)

47

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • North Carolina
      • Durham, North Carolina, 미국, 27710
        • Duke University Health System

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 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Diagnosis of recurrent/progressive WHO grade IV MG or WHO grade III MG. Pts with prior low-grade glioma are eligible if histologic assessment demonstrates transformation to WHO grade III / IV MG
  • >18 yrs
  • Karnofsky Performance Status >70 percent
  • Pts presenting in 1st, 2nd / 3rd relapse. Prior therapy must have included external beam XRT
  • Adequate bone marrow, liver & renal function as assessed by following:
  • Hemoglobin>9.0g/dl
  • ANC>1,500/mm3
  • Platelet count>100,000/mm3
  • Total bilirubin<1.5 x ULN
  • ALT & AST<2.5 x ULN
  • INR<1.5 or PT/PTT within normal limits. Pts receiving anti-coagulation treatment w low-molecular weight heparin allowed to participate, oral warfarin is not permitted
  • Creatinine<1.5 x ULN
  • Serum Na, K+, Mg2+, Phosphate & Ca2+ >LLN
  • Interval<2 wks between prior surgical resection & initiation of study regimen
  • Interval <12 weeks from completion of standard, daily XRT, unless one of following occurs: new area of enhancement on MRI imaging that is outside XRT field; biopsy proven recurrent tumor; / radiographic evidence of progressive tumor on 2 consecutive scans >4 wks apart.
  • Interval <4weeks from prior chemotherapy unless there is unequivocal evidence of tumor progression & pt has recovered from all anticipated toxicities from prior therapy
  • Interval <4weeks from prior investigational agent unless there is unequivocal evidence of tumor progression & pt has recovered from all anticipated toxicities from prior therapy
  • Signed written informed consent including HIPAA according to institutional guidelines. Signed informed consent must be obtained prior to any study specific procedures
  • If sexually active, pts will take contraceptive measures for duration of treatments & for 4 weeks following discontinuation of dasatinib & Erlotinib.
  • Women of childbearing potential must have negative serum or urine pregnancy test within 72 hrs prior to start of study drug administration

Exclusion Criteria:

  • No prior dasatinib / oral EGFR-inhibitor therapy
  • Pregnancy/breast feeding
  • History of significant concurrent illness

    ->3 prior episodes of progressive disease

  • Significant cardiac disease
  • Excessive risk of bleeding as defined by stroke <6 months, history of CNS / intraocular bleed,/ septic endocarditis.
  • Concurrent severe and/or uncontrolled medical disease that could compromise participation in study including any of following: pleural / pericardial effusion of any grade; uncontrolled diabetes; uncontrolled hypertension; active clinically serious infection >CTCAEv3 Gr2 requiring active intervention; history of clinically-significant bleeding diathesis or coagulopathy including platelet function disorder or acquired bleeding disorder within 1yr; impairment of GI function /GI disease that may significantly alter absorption of study regimen; ongoing or recent significant gastrointestinal bleeding
  • Thrombolic or embolic events such as cerebrovascular accident including transient ischemic attacks <6 months
  • Any hemorrhage/bleeding event >CTCAEv3AE Gr3 within 4wks of 1st dose of study drug
  • Serious non-healing wound, ulcer, /bone fracture
  • Major surgery, open biopsy /significant traumatic injury <4 weeks of 1st study drug
  • Known HIV infection/chronic Hepatitis B/C
  • Pt is <3yrs free of another primary malignancy except: if other primary malignancy is either not currently clinically significant/does not require active intervention. Existence of any other malignant disease is not allowed.
  • Pts unwilling to/unable to comply with protocol including ability to swallow whole pills/presence of any malabsorption syndrome
  • Concurrent administration of warfarin, rifampin/St. John's Wort
  • Subjects w hypokalemia/hypomagnesemia if it cannot be corrected
  • Prisoners/subjects who are compulsorily detained for treatment of either psychiatric/physical illness

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
실험적: Stratum A
Pts not on EIAEDs
You will begin study drug regimen on day 1 of cycle 1 w Dasatinib. If you are undergoing Dasatinib pharmacokinetic blood analysis, Dasatinib will be taken alone until initial PK assessments are collected. Erlotinib will be begin after initial Dasatinib PK assessments are collected & will continue to be administered w Dasatinib on continuous daily dosing schedule. Initial Dasatinib PK assessments will be collected over 24hrs between days 3-7 of cycle 1 & at end of cycle 1. If you are not undergoing Dasatinib PK collections you will begin both Dasatinib & Erlotinib together on day 1 of cycle 1. Both drugs will be given in continuous daily oral manner. Cycle is defined as Dasatinib & Erlotinib given daily for 28 days for purpose of scheduling evaluations.
다른 이름들:
  • 타세바
  • 스프라이셀
  • 엘로티닙
  • 다사티닙
실험적: Stratum B
Pts on EIAEDs
You will begin study drug regimen on day 1 of cycle 1 w Dasatinib. If you are undergoing Dasatinib pharmacokinetic blood analysis, Dasatinib will be taken alone until initial PK assessments are collected. Erlotinib will be begin after initial Dasatinib PK assessments are collected & will continue to be administered w Dasatinib on continuous daily dosing schedule. Initial Dasatinib PK assessments will be collected over 24hrs between days 3-7 of cycle 1 & at end of cycle 1. If you are not undergoing Dasatinib PK collections you will begin both Dasatinib & Erlotinib together on day 1 of cycle 1. Both drugs will be given in continuous daily oral manner. Cycle is defined as Dasatinib & Erlotinib given daily for 28 days for purpose of scheduling evaluations.
다른 이름들:
  • 타세바
  • 스프라이셀
  • 엘로티닙
  • 다사티닙

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
To determine MTD & DLT of Dasatinib when combined w Erlotinib among pts w Recurrent MG
기간: 12 months
12 months

2차 결과 측정

결과 측정
기간
To further evaluate safety & tolerability of Dasatinib + Erlotinib
기간: 12 months
12 months
To evaluate the PK of Dasatinib when administered w Erlotinib among Recurrent MG pts who are on & not on EIAEDs
기간: 12 months
12 months
To evaluate for anti-tumor activity w this regimen in this pt population
기간: 12 months
12 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

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

2008년 1월 1일

기본 완료 (실제)

2010년 7월 1일

연구 완료 (실제)

2010년 7월 1일

연구 등록 날짜

최초 제출

2008년 1월 25일

QC 기준을 충족하는 최초 제출

2008년 1월 25일

처음 게시됨 (추정)

2008년 2월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 7월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 7월 15일

마지막으로 확인됨

2012년 4월 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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