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NCT01966445 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of GSK2849330 in Subjects With Advanced Her3-Positive Solid Tumors
A Phase 1 study of Cancer and Neoplasms, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
- 14
- Study locations
NCT01966445: Completed Phase 1 study of Cancer and Neoplasms, sponsored by GlaxoSmithKline.
NCT01966445 is a Phase 1 study of Cancer and Neoplasms that has completed, run by GlaxoSmithKline. The registered enrollment target is 29 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower). The trial reports 14 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01966445, a Phase 1 study of Cancer and Neoplasms, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
- 14
- Study locations
Study Summary
Human Epidermal Growth Factor Receptor 3 (HER3) expression is seen across a wide variety of solid malignancies and is associated with poor prognosis. Up-regulation of HER3 expression and activity is also associated with resistance to multiple pathway inhibitors. GSK2849330, a monoclonal antibody targeting HER3, is a new agent for subjects whose tumors express HER3. This study is a phase I, first time in human, open-label, dose escalation study. The purpose of this study is to investigate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of GSK2849330 in subjects with advanced HER3-positive solid tumors. The study will be conducted in two parts. Part 1 (Dose-Escalation Phase) will include dose escalation and PK/PD cohorts to evaluate safety, PK, and PD to guide selection of dose regimen(s) for Part 2. In Part 2 (Expansion Cohorts), up to 3 cohorts will be enrolled at the dose regimen(s) selected based on Part 1 data, to evaluate safety in a larger cohort of subjects at the recommended dose regimen and also to evaluate preliminary evidence of clinical benefit.
Primary Outcome
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require
Interventions
- BIOLOGICAL GSK2849330
Study Locations (14)
Other
- GSK Investigational Site - Amsterdam
- GSK Investigational Site - Amsterdam
- GSK Investigational Site - Groningen
- GSK Investigational Site - Groningen
- GSK Investigational Site - Nijmegen
- GSK Investigational Site - Nijmegen
- GSK Investigational Site - Rotterdam
- GSK Investigational Site - Rotterdam
Victoria
- GSK Investigational Site - Heidelberg
- GSK Investigational Site - Melbourne
Colorado
- GSK Investigational Site - Aurora
New York
- GSK Investigational Site - New York
Utah
- GSK Investigational Site - Salt Lake City
Western Australia
- GSK Investigational Site - Nedlands
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2013-11-26 |
| Est. Completion | 2017-09-18 |
| Phase | Phase 1 |
What the finished NCT01966445 record still lists
NCT01966445 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Cancer appearing as the primary indexed condition, and to 1 intervention - of which GSK2849330 is the first listed.
NCT01966445 lists 14 locations in 6 states (Other, Victoria, Colorado).
Frequently Asked Questions
What is clinical trial NCT01966445 about?
NCT01966445 is a clinical study titled "Dose Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of GSK2849330 in Subjects With Advanced Her3-Positive Solid Tumors". Human Epidermal Growth Factor Receptor 3 (HER3) expression is seen across a wide variety of solid malignancies and is associated with poor prognosis. Up-regulation of HER3 expression and activity is also associated with resistance to multiple pathway inhibitors. GSK2849330, a monoclonal antibody tar...
What is the current status of trial NCT01966445?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2013-11-26. Estimated completion is 2017-09-18.
What conditions does trial NCT01966445 study?
This clinical trial studies the following conditions: Cancer, Neoplasms.
What interventions are being tested in trial NCT01966445?
The interventions under investigation include: GSK2849330 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01966445?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01966445 being conducted?
This trial has 14 study locations across Colorado, New York, Utah, Victoria, Western Australia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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29 524th of 615 higher than 89 of 615 other Cancer trials
participants (enrollment target), bucketed by value
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