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A Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LGX818 in Adult Patients With Locally Advanced or Metastatic BRAF Mutant Melanoma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Melanoma and Metastatic Colorectal Cancer

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Trial Information

A Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LGX818 in Adult Patients With Locally Advanced or Metastatic BRAF Mutant Melanoma


Inclusion Criteria:



For the dose escalation phase:

1. 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.

2. Written documentation of BRAF V600E mutation, or any other BRAF V600 mutation.

3. Evidence of measurable disease

Exclusion Criteria:

1. Previous therapy with a MEK inhibitor.

2. Symptomatic or untreated leptomeningeal disease.

3. 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.

4. Known acute or chronic pancreatitis.

5. Clinically significant cardiac disease

6. Impairment of gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of oral LGX818

7. 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.

8. 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).

9. History of thromboembolic or cerebrovascular events within the last 6 months

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of Dose Limiting Toxicities

Outcome Time Frame:

Approximately every 8 weeks (up to 2 years)

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLGX818X2101

NCT ID:

NCT01436656

Start Date:

September 2011

Completion Date:

May 2014

Related Keywords:

  • Melanoma and Metastatic Colorectal Cancer
  • BRAF mutant,
  • BRAF mutated,
  • melanoma,
  • metastatic,
  • advanced,
  • RAF kinase inhibitor
  • BRAF V600 mutation
  • Colorectal Neoplasms
  • Melanoma

Name

Location

Massachusetts General Hospital Mass General 2 Boston, Massachusetts  02114
oH. Lee Moffitt Cancer Center/University of South Florida Moffitt SC Tampa, Florida  33612