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A Single-Arm, Open-Label, Multi-Center Study to Investigate the Objective Response Rate, Safety, and Pharmacokinetics of GSK1120212, a MEK Inhibitor, in Subjects With Metastatic Uveal Melanoma or With Mutation-Positive GNAQ or GNA11 Metastatic Melanoma


Phase 2
18 Years
N/A
Not Enrolling
Both
GNA11 Mutation-positive Metastatic Melanoma, GNAQ Mutation-positive Metastatic Melanoma, Cancer, Metastatic Uveal Melanoma

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Trial Information

A Single-Arm, Open-Label, Multi-Center Study to Investigate the Objective Response Rate, Safety, and Pharmacokinetics of GSK1120212, a MEK Inhibitor, in Subjects With Metastatic Uveal Melanoma or With Mutation-Positive GNAQ or GNA11 Metastatic Melanoma


Inclusion Criteria:



- Histologically or cytologically confirmed diagnosis of metastatic uveal melanoma or
previously documented mutation-positive GNAQ or GNA11 metastatic melanoma not
previously treated with a MEK inhibitor.

- Provide archival tumor tissue or, if tissue blocks are not available, undergo fresh
tumor biopsy prior to enrollment.

- The patient has a radiographically measurable tumor.

- ECOG performance status 0, 1, or 2.

- The patient is able to swallow and retain oral medication.

- Life expectancy of at least 4 months.

- Toxicities from previous anti-cancer therapy (except alopecia) are recovered (Grade 1
or less) at the time of enrollment.

- The patient has adequate organ and bone marrow function.

- Sexually active patients must use medically acceptable methods of contraception
during the course of the study.

- Female patients of childbearing potential must have a negative serum pregnancy test
at screening.

Exclusion Criteria:

- The patient has had any of the following within 21 days of starting study drug or
anticipates the need for any of the following during the course of study treatment:
chemotherapy, immunotherapy, biologic therapy, hormone therapy, major surgery, or
tumor embolization.

- The patient has received experimental therapy within 21 days of starting study drug.

- The patient has received nitrosourea or mitomycin C within 42 days of starting study
drug.

- The patient has received any herbal medications or palliative radiotherapy within 14
days of starting study drug.

- The patient is currently receiving anticoagulation therapy that is not well
controlled.

- Ongoing or newly diagnosed eye abnormality other than symptoms due to uveal melanoma.

- History of retinal vein occlusion or central serous retinopathy.

- Current severe, uncontrolled systemic disease.

- History of leptomeningeal disease or spinal cord compression secondary to metastasis.

- Brain metastasis, unless previously treated with surgery, whole-brain radiation or
stereotactic radiosurgery and the disease has been stable for at least 3 months
without steroid use or on a stable dose of steroids for at least 1 month prior to
starting study drug. Stability of brain metastases must be confirmed with imaging.

- The patient has a concurrent, active hematological malignancy or other solid tumor
malignancy.

- History of clinically significant cardiac or pulmonary dysfunction.

- Allergy or hypersensitivity to components of the GSK1120212 formulation.

- The patient is pregnant or breastfeeding.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate as assessed by RECIST v1.1

Outcome Time Frame:

At least 12 weeks after initiating study treatment

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

114091

NCT ID:

NCT01328106

Start Date:

November 2010

Completion Date:

May 2012

Related Keywords:

  • GNA11 Mutation-positive Metastatic Melanoma
  • GNAQ Mutation-positive Metastatic Melanoma
  • Cancer
  • Metastatic Uveal Melanoma
  • Melanoma
  • Uveal Neoplasms

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