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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 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.

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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.

Conditions Studied

Solid Tumor Unspecified Adult Solid Tumor, Protocol Specific

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

1,845 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, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 222-participant average among 196 other Solid Tumor trials with a reported enrollment target (87% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

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 reports 6 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.