Status:
TERMINATED
A Study of Vismodegib in Patients With Relapsed/Refractory Acute Myelogenous Leukemia and Relapsed Refractory High-Risk Myelodysplastic Syndrome
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Myelodysplastic Syndromes, Myelogenous Leukemia, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will assess the safety and efficacy of vismodegib in patients with relapsed/refractory acute myelogenous leukemia (AML) and relapsed/refractory high-risk myelodysplastic syndrome (MDS). Pat...
Eligibility Criteria
Inclusion
- 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 National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade \</= 2 prior to starting therapy
- Adequate hepatic and renal function
Exclusion
- 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 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01880437
Start Date
September 1 2013
End Date
November 1 2014
Last Update
December 15 2015
Active Locations (14)
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1
Stanford, California, United States, 94305
2
Ann Arbor, Michigan, United States, 48109
3
Kansas City, Missouri, United States, 64131
4
New York, New York, United States, 10065