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An Open-label Mass Balance Study to Investigate the Absorption, Distribution, Metabolism and Elimination of a Single Oral Dose of MEK Inhibitor [14C]GSK1120212 in Male Subjects With Solid Tumors

Phase 1
18 Years
Not Enrolling
Solid Tumours, Cancer

Thank you

Trial Information

An Open-label Mass Balance Study to Investigate the Absorption, Distribution, Metabolism and Elimination of a Single Oral Dose of MEK Inhibitor [14C]GSK1120212 in Male Subjects With Solid Tumors

Inclusion Criteria:

1. Male 18 years old or older.

2. Written informed consent provided

3. Body weight greater than or equal to 45 kg and a BMI greater than or equal to 19
kg/m2 and less than or equal to 35 kg/m2 (inclusive).

4. Able to swallow and retain oral medication.

5. Histologically or cytologically confirmed diagnosis of a solid tumor.

6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

7. Agree to use one of the contraception methods listed in the protocol from the time of
the first dose of study medication until sixteen weeks after the last dose of study

8. A history of regular bowel movements (approximately once per day).

9. Adequate baseline organ function as listed in the protocol.

Exclusion Criteria:

1. Currently receiving cancer therapy as specified in the protocol.

2. Serious and/or unstable pre-existing medical psychiatric disorder, or other

3. Any major surgery within the last four weeks.

4. Unresolved toxicity equal to or greater than Grade 2 from previous anti-cancer
therapy except alopecia.

5. An occupation within the past 12 months which requires monitoring for radiation
exposure, nuclear medicine procedures or excessive x-rays.

6. Radiation exposure from the previous three year period over 10 mSv if exposed to
ionizing radiation above background as a result of work with radiation as category A
(classified) workers or as a result of research studies.

7. History of interstitial lung disease or pneumonitis.

8. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to dimethyl
sulfoxide (DMSO).

9. Current use of a prohibited medications described in the protocol.

• Use of anticoagulants such as warfarin is permitted.

10. History RVO or CSR.

- Predisposing factors to RVO or CSR.

- Visible retinal pathology that is considered a risk factor for RVO or CSR such

- Evidence of new optic disc cupping

- Intraocular pressure greater than 21 mm Hg as measured by tonography. 11.1.
Symptomatic or untreated leptomeningeal or brain metastases or spinal cord
compression. (Previously treated and have had stable CNS disease for greater
than 3 months, asymptomatic and off corticosteroids, or on stable dose of
corticosteroids for at least 1 month prior to study Day 1 are permitted).

11.2. Receiving enzyme inducing anti-epileptic drugs (EIAEDs). 12. History of acute
coronary syndromes (including myocardial infarction and unstable angina), coronary
angioplasty, or stenting within the past 6 months. 13. QTcB greater than or equal to 480
msec. 14. History or evidence of current clinically significant uncontrolled arrhythmias.

15. History or evidence of current greater than or equal to Class II congestive heart

16. Active gastrointestinal disease or other condition (e.g., gastrectomy, bariatric
surgery, small bowel or large bowel resection, or cholecystectomy).

17. A history of known Human Immunodeficiency Virus (HIV), Hepatitis B Virus, or Hepatitis
C Virus.

18. Alcohol or drug abuse within six months prior to screening. 19. Known immediate or
delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study
drugs or excipients.

20. Participated in a clinical trial and has received an investigational product within 30
days or five half-lives or twice the duration of the biological effect of the
investigational product (whichever is longer) before the 1st dose.

21. Where participation in the study would result in donation of blood or blood products
in excess of 500 mL within a 56 day period.

22. Mentally or legally incapacitated.

Type of Study:


Study Design:

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

Outcome Measure:

Total excretion of radioactivity

Outcome Description:

• Total and relative excretion of radioactivity in urine and feces following a single, 2 mg oral solution dose of [14C]GSK1120212

Outcome Time Frame:

11 days

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

February 2011

Completion Date:

October 2011

Related Keywords:

  • Solid Tumours
  • Cancer
  • MEK inhibitor
  • elimination
  • Phase 1
  • GSK1120212
  • cancer
  • Pharmacokinetics
  • oncology
  • radiolabeled ADME



GSK Investigational Site Seattle, Washington  98133