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NCT01337765 · ClinicalTrials.gov registry record · Phase 1
Safety, Pharmacokinetics and Pharmacodynamics of BEZ235 Plus MEK162 in Selected Advanced Solid Tumor Patients
A Phase 1 study of Solid Tumor and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
- 6
- Study locations
NCT01337765: Completed Phase 1 study of Solid Tumor and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Pfizer.
NCT01337765 is a Phase 1 study of Solid Tumor and Unspecified Adult Solid Tumor, Protocol Specific that has completed, run by Pfizer. The registered enrollment target is 29 participants, below the 222-participant average among 196 other Solid Tumor trials with a reported enrollment target (87% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01337765, a Phase 1 study of Solid Tumor and Unspecified Adult Solid Tumor, Protocol Specific, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or RP2D of the orally administered PI3K/mTOR inhibitor BEZ235 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with EGFR mutant 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 BEZ235 and MEK162. Study drugs will be administered orally on a continuous schedule, MEK162 bid and BEZ235 qd, a treatment cycle is defined as 28 days.
Primary Outcome
A complete treatment cycle is defined as 28 days of daily continuois treatment with study drug combination
Conditions Studied
Interventions
- DRUG BEZ235 + MEK162
Study Locations (6)
Massachusetts
- Massachusetts General Hospital Mass General 2 - Boston
Texas
- University of Texas/MD Anderson Cancer Center MD Anderson PSC - Houston
Victoria
- Pfizer Investigative Site - Parkville
Ontario
- Pfizer Investigative Site - Toronto
Other
- Pfizer Investigative Site - Villejuif
Catalonia
- Pfizer Investigative Site - Barcelona
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2011-07-08 |
| Est. Completion | 2013-03-22 |
| Phase | Phase 1 |
What the finished NCT01337765 record still lists
NCT01337765 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 222-participant average among 196 other Solid Tumor trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which BEZ235 + MEK162 is the first listed.
NCT01337765 lists 6 locations in 6 states (Massachusetts, Texas, Victoria).
Frequently Asked Questions
What is clinical trial NCT01337765 about?
NCT01337765 is a clinical study titled "Safety, Pharmacokinetics and Pharmacodynamics of BEZ235 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 RP2D of the orally administered PI3K/mTOR inhibitor BEZ235 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with EGFR mutant NSCLC which has...
What is the current status of trial NCT01337765?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2011-07-08. Estimated completion is 2013-03-22.
What conditions does trial NCT01337765 study?
This clinical trial studies the following conditions: Solid Tumor, Unspecified Adult Solid Tumor, Protocol Specific.
What interventions are being tested in trial NCT01337765?
The interventions under investigation include: BEZ235 + MEK162 (DRUG).
Who is sponsoring clinical trial NCT01337765?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01337765 being conducted?
This trial has 6 study locations across Massachusetts, Texas, Victoria, Ontario, Catalonia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Solid Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01337765's enrollment target sits among peer trials
29 162nd of 196 higher than 33 of 196 other Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumor 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
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