Last updated: 11/07/2018 08:33:31
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.

Absolute Bioavialability of GSK1120212

GSK study ID
115064
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Determination of the Absolute Bioavailability of GSK1120212 Following a Single Oral Dose Co-Administered with an Intravenous Radiolabelled Microdose of GSK1120212 in Subjects with solid Tumors
Trial description: A Phase I, single-center, open-label, single-persiod, combined single dose oral and IV microtracer study in subjects with solid tumors.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Determine the the absolute bioavailability of GSK1120212 following single oral tablet dose co-administered with an IV microdose.

Timeframe: Pre-dose, 0.5h, 1h, 1.5h, 1.55h, 1.75h,2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 24h, 48h, 72h, 120h, 168h, and 240h.

Secondary outcomes:

Determine the single dose PK of GSK1120212 following oral administration.

Timeframe: Pre-dose, 0.5h, 1h, 1.5h, 1.75h,2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 24h, 48h, 72h, 120h, 168h, and 240h.

Determine the single dose PK of GSK1120212 following IV administration.

Timeframe: 1.55h, 1.75h,2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 24h, 48h, 72h, 120h, 168h, and 240h.

AEs

Timeframe: Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 11, and follow-up.

Blood pressure

Timeframe: Screening, Day 1, Day 2, and follow-up.

Pulse rate

Timeframe: Screening, Day 1, Day 2, and follow-up.

ECG

Timeframe: Screening, Day 1, Day 2, and follow-up.

Echo

Timeframe: Screening day and follow-up

Clinical Laboratory data

Timeframe: Screening, Day 1, and follow-up.

Interventions:
Drug: GSK1120212
Drug: GSK1120212B
Enrollment:
6
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Cathrine L. Denton, Carolyn Pendry, John Bauman, Graeme C. Young, May Ho, Frank Henriquez, Lei Fang, Royce A. Morrison, Keith Orford, Daniele Ouellet .Concomitant Oral and Intravenous Pharmacokinetics of Trametinib, a MEK Inhibitor, in Subjects With Solid Tumours.Br J Clin Pharmacol.2014;78(3):524–532
Medical condition
Cancer
Product
trametinib
Collaborators
Not applicable
Study date(s)
June 2011 to December 2011
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • 1. Male or female at least 18 years of age at the time of signing the informed consent form
  • 2. Histologically or cytologically confirmed diagnosis of a solid tumor that is not responsive to
  • 1. Currently receiving cancer therapy (e.g., chemotherapy with delayed toxicity, extensive
  • radiation therapy, immunotherapy, biologic therapy, or major surgery) within the last 3 weeks;

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Tacoma, Washington, United States, 98418
Status
Study Complete

Study documents

Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
2011-17-12

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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Additional information
Results for study 115064 can be found on the GSK Clinical Study Register.
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