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NCT01363232 · ClinicalTrials.gov registry record · Phase 1
Safety, Pharmacokinetics and Pharmacodynamics of BKM120 Plus MEK162 in Selected Advanced Solid Tumor Patients
A Phase 1 study, sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 89
- Enrollment target
NCT01363232 is a Phase 1 study that has completed, run by Array Biopharma, now a wholly owned subsidiary of Pfizer. The registered enrollment target is 89 participants.
The verdict
NCT01363232, a Phase 1 study, has completed, sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 89 participants
- Enrollment target
Study Summary
This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of the orally administered phosphatidylinositol 3'-kinase (PI3K) inhibitor BKM120 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) which has progressed on EGFR inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two expansion arms will be opened in order to further assess safety and preliminary anti-tumor activity of the combination of BKM120 and MEK162. Study drugs will be administered once daily orally on a continuous schedule. A treatment cycle is defined as 28 days.
Interventions
- DRUG BKM120 + MEK162
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2011-08 |
| Est. Completion | 2017-12-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01363232
The ClinicalTrials.gov registry entry for NCT01363232 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 89 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 BKM120 + MEK162 is the first listed.
NCT01363232 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01363232 about?
NCT01363232 is a clinical study titled "Safety, Pharmacokinetics and Pharmacodynamics of BKM120 Plus MEK162 in Selected Advanced Solid Tumor Patients". This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of the orally administered phosphatidylinositol 3'-kinase (PI3K) inhibitor BKM120 in combination with the MEK1/2 inhibitor MEK162. This combination w...
What is the current status of trial NCT01363232?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 89 participants. The study started on 2011-08. Estimated completion is 2017-12-18.
What interventions are being tested in trial NCT01363232?
The interventions under investigation include: BKM120 + MEK162 (DRUG).
Who is sponsoring clinical trial NCT01363232?
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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