A phase IB/II study to evaluate the safety and efficacy of vismodegib in relapsed/refractory acute myelogenous leukemia (AML) and relapsed/refractory high-risk myelodysplastic syndrome (MDS).

F. Hoffmann-La Roche Ltd.0 个研究点目标入组 60 人开始时间: 2013年7月10日最近更新: 2014年11月24日

适应症

试验速览

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•- Adult patients, >/= 18 years of age
•- Patients with documented relapsed or refractory AML, except acute promyelocytic leukemia (APL [M3 subtype]), or relapsed or refractory high-risk MDS (high-risk MDS defined as International Prognostic Scoring System (IPSS) Int-2 or high and >/= 10% blasts in bone marrow)
•- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
•- Negative serum pregnancy test for women of childbearing potential and use of
•two forms of contraception while enrolled in the study and for 7 months after the patient discontinues from study
•- Male patients with female partners of childbearing potential must agree to use a latex condom and to advise their female partner to use an additional method of contraception during the study and for 2 months after the last dose of vismodegib
•- All non-hematological adverse events of any prior chemotherapy, surgery, or radiotherapy must have resolved to NCI CTCAE Grade - Adequate hepatic and renal function
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 36
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 24

•- Prior treatment with a Hh pathway inhibitor
•- Prior therapy for the treatment of malignancy within 14 days of Day 1, with the exception of: Hydroxyurea in patients who need to continue this agent to maintain WBC counts - Current evidence of active CNS leukemia
•- Any other active malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix)
•- Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
•Unstable angina, symptomatic or otherwise uncontrolled arrhythmia requiring medication (does not include stable, lone atrial fibrillation), or myocardial infarction - Any active (acute or chronic) or uncontrolled infection/disorders that impair the ability to evaluate the patient or for the patient to complete the study
•- Pregnant or breast-feeding women
•- Patients who refuse to potentially receive blood products and/or have a severe hypersensitivity to blood products

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