Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212
Public ClinicalTrials.gov record NCT01072175. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label, Dose-Escalation, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the BRAF Inhibitor GSK2118436 in Combination With the MEK Inhibitor GSK1120212 in Subjects With BRAF Mutant Metastatic Melanoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This was an open-label, dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK2118436 and GSK1120212 in combination. This study was designed in four parts. In Part A, the effect of repeat doses of GSK1120212 on the pharmacokinetics of single dose GSK2118436 was investigated prior to evaluating combination regimens. In Part B, the range of tolerated dose combinations was identified using a dose-escalation procedure. In Part C, different dose combinations of GSK2118436 and GSK1120212 were evaluated, based on results from the dose escalation cohorts. In Part D, the pharmacokinetics and safety of GSK2118436 administered as HPMC capsules alone and in combination with GSK1120212 was evaluated.
Study identification
- NCT ID
- NCT01072175
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 430 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 26, 2010 (Actual)
- Primary completion
- May 31, 2012 (Actual)
- Completion
- Feb 27, 2018 (Actual)
- Last update posted
- Jul 5, 2019
2010 – 2018
United States locations
- U.S. sites
- 13
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Los Angeles | California | 90025 | — |
| Novartis Investigative Site | San Francisco | California | 94115 | — |
| Novartis Investigative Site | Aurora | Colorado | 80045 | — |
| Novartis Investigative Site | New Haven | Connecticut | 06520 | — |
| Novartis Investigative Site | Tampa | Florida | 33612 | — |
| Novartis Investigative Site | Lutherville-Timonium | Maryland | 21093 | — |
| Novartis Investigative Site | Boston | Massachusetts | 02114 | — |
| Novartis Investigative Site | Boston | Massachusetts | 02215 | — |
| Novartis Investigative Site | Rochester | Minnesota | 55905 | — |
| Novartis Investigative Site | Philadelphia | Pennsylvania | 19104 | — |
| Novartis Investigative Site | Nashville | Tennessee | 37203 | — |
| Novartis Investigative Site | Nashville | Tennessee | 37232 | — |
| Novartis Investigative Site | Houston | Texas | 77030-4009 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01072175, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 5, 2019 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01072175 live on ClinicalTrials.gov.