Status:
COMPLETED
Nilotinib and LDE225 in the Treatment of Chronic or Accelerated Phase Myeloid Leukemia in Patients Who Developed Resistance to Prior Therapy
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the feasibility of administering the combination of nilotinib and LDE225 to patients with chronic or accelerated phase of chronic myeloid leukemia and to esta...
Eligibility Criteria
Inclusion
- Philadelphia chromosome positive (Ph+) CML in chronic phase (CP) or accelerated phase (AP)with resistance to at least one prior BCR-ABL targeting TKI
- Documented chronic phase CML
- Adequate end organ function
- Female patients of childbearing potential must have a negative serum pregnancy test and must be using highly effective methods of contraception. Male patients with female partners of child-bearing potential must use condoms.
Exclusion
- Impaired cardiac function
- Severe and/or uncontrolled concurrent disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
- History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis
- Patients actively receiving therapy with strong CYP3A4 inhibitors and/or inducers, and the treatment cannot be either discontinued or switched to a different medication prior to entering the study
- Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either safely discontinued or switched to a different medication prior to starting study drug.
- Previously documented BCR-ABL Y253H, E255K/V, T315I or F359C/V mutation
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01456676
Start Date
January 1 2012
End Date
February 1 2014
Last Update
December 9 2020
Active Locations (7)
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1
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2M9
2
Novartis Investigative Site
Marseille, France, 13273
3
Novartis Investigative Site
Frankfurt, Germany, 60590
4
Novartis Investigative Site
Ulm, Germany, 89081