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NCT00959127 · ClinicalTrials.gov registry record · Phase 1
A Study of ARRY-438162 (MEK162) in Patients With Advanced Cancer
A Phase 1 study, sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 93
- Enrollment target
NCT00959127 is a Phase 1 study that has completed, run by Array Biopharma, now a wholly owned subsidiary of Pfizer. The registered enrollment target is 93 participants.
The verdict
NCT00959127, a Phase 1 study, has completed, sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 93 participants
- Enrollment target
Study Summary
This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-438162 (MEK162). This study has 3 parts. In the first part, patients with advanced solid tumors will receive increasing doses of study drug in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Approximately 30 patients from the US will be enrolled in Part 1. (Active, not recruiting) In the second part of the study, patients with advanced or metastatic biliary cancer will receive the best dose of study drug determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 25 patients from the US will be enrolled in Part 2. (Active, not recruiting) In the third part of the study, patients with metastatic colorectal cancer (CRC) will receive the best dose of the study drug determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 25 patients with KRAS mutation (Active, not recruiting) and 15 patients with BRAF mutation (Active, not recruiting) from the US will be enrolled in Part 3.
Interventions
- DRUG ARRY-438162 (MEK162), MEK inhibitor; oral
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2009-08 |
| Est. Completion | 2013-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00959127
The ClinicalTrials.gov registry entry for NCT00959127 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Array Biopharma, now a wholly owned subsidiary of Pfizer, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ARRY-438162 (MEK162), MEK inhibitor; oral is the first listed.
NCT00959127 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00959127 about?
NCT00959127 is a clinical study titled "A Study of ARRY-438162 (MEK162) in Patients With Advanced Cancer". This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-438162 (MEK162). This study has 3 parts. In the first part, patients with advanced solid tumors will receive increasing doses of study drug in order to achieve the highest dose of t...
What is the current status of trial NCT00959127?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 93 participants. The study started on 2009-08. Estimated completion is 2013-01.
What interventions are being tested in trial NCT00959127?
The interventions under investigation include: ARRY-438162 (MEK162), MEK inhibitor; oral (DRUG).
Who is sponsoring clinical trial NCT00959127?
This trial is sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer, which has 21 total clinical trials registered on ClinicalTrials.gov.
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