Status:
COMPLETED
A Phase I Study of Oral LGX818 in Adult Patients With Advanced or Metastatic BRAF Mutant Melanoma
Lead Sponsor:
Pfizer
Conditions:
Melanoma and Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
CLGX818X2101 is a first-time in-human, phase I study to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of daily administered LGX818 (daily, twice daily and/or every-...
Eligibility Criteria
Inclusion
- For the dose escalation phase:
- Histologically confirmed diagnosis of locally advanced or metastatic melanoma (stage IIIB to IV per American Joint Committee on Cancer \[AJCC\]). For the dose expansion phase: (i) Histologically confirmed diagnosis of locally advanced or metastatic melanoma (stage IIIB to IV per American Joint Committee on Cancer \[AJCC\]), or (ii) confirmed diagnosis and non-resectable advanced metastatic colorectal cancer (mCRC) for which no further effective standard therapy exists.
- Written documentation of BRAF V600E mutation, or any other BRAF V600 mutation.
- Evidence of measurable disease
Exclusion
- Previous therapy with a MEK inhibitor.
- Symptomatic or untreated leptomeningeal disease.
- Symptomatic or untreated brain metastasis.Patients previously treated for these conditions that are asymptomatic in the absence of corticosteroid therapy are allowed to enroll. Brain metastasis must be stable with verification by imaging.
- Known acute or chronic pancreatitis.
- Clinically significant cardiac disease
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LGX818
- Previous or concurrent malignancy. Exceptions to this exclusion criteria include: adequately treated basal cell or squamous cell skin cancer; in situ carcinoma of the cervix, treated curatively and without evidence of recurrence for at least 3 years prior to study entry; or other solid tumor treated curatively, and without evidence of recurrence for at least 3 years prior to study entry.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 5 mIU/mL).
- History of thromboembolic or cerebrovascular events within the last 6 months
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
September 5 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2022
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT01436656
Start Date
September 5 2011
End Date
November 7 2022
Last Update
October 28 2024
Active Locations (24)
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1
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215