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COMPLETED Phase 1

Safety, Pharmacokinetics and Pharmacodynamics of BEZ235 Plus MEK162 in Selected Advanced Solid Tumor Patients

NCT01337765 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 29 participants
Start Date 2011-07-08
Est. Completion 2013-03-22
Phase Phase 1

Sponsor

Pfizer

769 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01337765

The ClinicalTrials.gov registry entry for NCT01337765 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01337765 reports 6 study locations spanning 6 distinct geographic areas — top geographies include Massachusetts, Texas, Victoria. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01337765?

The interventions under investigation include: BEZ235 + MEK162 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01337765?

This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial