Safety and Efficacy of AEB071 in Metastatic Uveal Melanoma Patients
NCT ID: NCT01430416
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
153 participants
INTERVENTIONAL
2011-12-20
2019-05-22
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AEB071
AEB071
Interventions
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AEB071
Eligibility Criteria
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Inclusion Criteria
* Males and females ≥ 18 years of age
* Consent to biopsy of tumor
* Measurable disease according to RECIST version 1.1
* WHO performance status of ≤ 1
Exclusion Criteria
* Patients who are receiving treatment with strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued prior to study entry
* Patients with impaired cardiac function or clinically significant cardiac diseases as defined by the protocol
* Patients with another malignancy that was treated within the last three years with the exceptions of localized basal cell carcinoma and cervical carcinoma
* Patients with impairment of gastrointestinal function or disease
* Patients with severe systemic infections
* Patients who are known to be HIV positive and/or have active hepatitis B or C infection
* Time since last therapy for treatment of underlying malignancy:
* Cytotoxic chemotherapy: ≤ duration of the most recent cycle of the previous regimen (a minimum of 2 weeks for all)
* Nitrosurea: ≤ 6 weeks
* Biologic therapy: ≤ 4 weeks
* ≤ 5 x PK half-life of a small molecule therapeutic not otherwise defined above
* Patients having undergone major surgery less than 4 weeks prior to enrollment or have not fully recovered from prior surgery
* Women of child-bearing potential unless they are using highly effective methods of contraception during the dosing and for at least 36 hours after last dose. Highly effective contraception as defined in the protocol.
* Patients with primary central nervous system tumors or brain metastases.
* Pregnant or nursing (lactating) women.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Dana Farber Cancer Institute DFCI - Brookline
Boston, Massachusetts, United States
Memorial Sloan Kettering MSKCC 4
New York, New York, United States
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Leiden, , Netherlands
Novartis Investigative Site
London, , United Kingdom
Countries
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Related Links
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Results for COEB071X2102 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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2011-002535-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
COEB071X2102
Identifier Type: -
Identifier Source: org_study_id