A Study of Vismodegib in Patients With Relapsed/Refractory Acute Myelogenous Leukemia and Relapsed Refractory High-Risk Myelodysplastic Syndrome
NCT ID: NCT01880437
Last Updated: 2015-12-15
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
38 participants
INTERVENTIONAL
2013-09-30
2014-11-30
Brief Summary
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Anticipated time on study treatment is until disease progression, intolerable toxicity, or patient withdrawal of consent.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vismodegib
cytarabine
Cohort 2: 20 mg sc daily for 10 days starting Day 1, with a possible further cycle of 20 mg sc daily for 5 days starting no earlier than Day 29
vismodegib
Cohorts 1 and 2: 150 mg orally daily
Interventions
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cytarabine
Cohort 2: 20 mg sc daily for 10 days starting Day 1, with a possible further cycle of 20 mg sc daily for 5 days starting no earlier than Day 29
vismodegib
Cohorts 1 and 2: 150 mg orally daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade \</= 2 prior to starting therapy
* Adequate hepatic and renal function
Exclusion Criteria
* 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 white blood cell (WBC) counts \</= 50,000/mL. Hydroxyurea must be discontinued by Day 14 of the study
* Current evidence of active central nervous system (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 \</= 6 months before study treatment start 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Stanford, California, United States
Ann Arbor, Michigan, United States
Kansas City, Missouri, United States
New York, New York, United States
Houston, Texas, United States
Edmonton, Alberta, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Braunschweig, , Germany
Essen, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Münster, , Germany
Countries
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Other Identifiers
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2013-001570-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GO28852
Identifier Type: -
Identifier Source: org_study_id