A Study of the Safety and Activity of the MEK Inhibitor Given Together With the AKT Inhibitor to Patients With Multiple Myeloma or Solid Tumor Cancers

Completed · Phase 1

Conditions studied: Cancer

In brief

The purpose of this study is to determine whether the MEK inhibitor and the AKT inhibitor can be given in combination and if the combination is effective treatment for patients with solid tumors, including breast cancer and endometrial cancer, and for patients with multiple myeloma.

Key facts

Study ID

NCT01476137

Run by

GlaxoSmithKline

People needed

335

Starts

2011-10-26

Expected to finish

2013-03-12

Last updated by the study team

2017-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Chemotherapy, radiotherapy, immunotherapy or other anti-cancer therapy including investigational drugs within 14 days prior to the first dose of any one of the investigational drugs described in this study.
• History of an allogenic stem cell transplant. Subjects with a history of an autologous stem cell transplant are NOT excluded from Part 2A if they meet Part 2A inclusion criteria.
• Current use of prohibited medication during treatment with GSK1120212 and/ or GSK 2110183.
• History of Type 1 diabetes.
• Anticoagulants are permitted only if the subject meets PTT and INR entry criteria. Their use must be monitored in accordance with local institutional practice.
• Presence of active gastrointestinal disease or other condition that could affect gastrointestinal absorption (eg, malabsorption syndrome) or predispose subject to gastrointestinal ulceration.
• Evidence of mucosal or internal bleeding.
• Any major surgery within the last 4 weeks.
• Any serious or unstable pre-existing medical, psychiatric, or other condition (including lab abnormalities) that could interfere with the subject's safety or providing informed consent.
• Known active infection requiring parenteral or oral anti-infective treatment.
• Evidence of severe or uncontrolled systemic diseases (eg, unstable or uncompensated respiratory, hepatic, renal or cardiac disease, unstable hypertension).
• Subjects with brain metastases are excluded if their brain metastases are: symptomatic, treated (surgery, radiation therapy) but not clinically and radiologically stable one month after therapy (as assessed by at least 2 distinct contrast enhanced MRI or CT scans over at least a one month period) OR asymptomatic and untreated but > 1 cm in the longest dimension.
• Subjects with small (less than or equal to 1cm in the longest dimension), asymptomatic brain metastases that do not need immediate therapy can be enrolled. Subjects with solid tumors on a stable (ie, unchanged) dose of corticosteroids for more than one month, or those who have been off corticosteroids for at least 2 weeks can be enrolled. Subjects must also be off of enzyme-inducing anticonvulsants for more than 4 weeks.
• Subjects with leptomeningeal disease are excluded.
• QTcF interval greater than or equal to 470msecs.
• Subjects with bundle branch block (BBB) or pacemaker.
• Other clinically significant ECG abnormalities including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block.
• History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 6 months of Screening.
• Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
• Known hypersensitivity to any of the components of the study treatment.
• Pregnant or lactating female.
• Any malignancy related to HIV or solid organ transplant; history of known HIV, history of known HBV surface antigen positivity (subjects with documented laboratory evidence of HBV clearance may be enrolled) or positive HCV antibody.
• History or current evidence/ risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR): history of RVO or CSR, or predisposing factors to RVO or CSR at the time of screening (eg, uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension, diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes); visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or CSR, such as evidence of new optic disc cupping, evidence of new visual field defects, intraocular pressure (IOP) > 24mmHg.

Where it is running

• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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