Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer.
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01363232 record still lists
NCT01363232 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% higher).
The record links to 0 conditions, and to 1 intervention - of which BKM120 + MEK162 is the first listed.
NCT01363232 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01363232's enrollment target sits among peer trials
89 649th of 2000 higher than 1,351 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03682289 · 89 participants · Phase 2
Ceralasertib (AZD6738) Alone and in Combination With Olaparib or Durvalumab in Patients With Solid Tumors
- NCT04787939 · 89 participants · NA
Early Feeding After Oral Cavity Reconstruction
- NCT05480449 · 89 participants · Phase 1
Autologous HuCART19 T Cells Manufactured Using the CliniMACS Prodigy Platform for Pediatric B-ALL (huCART19 Prodigy)
- NCT05604131 · 89 participants · Phase 2
Cardiac MRI-guided Deferiprone Therapy for Acute Myocardial Infarction Patients
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia