Safety, Pharmacokinetics and Pharmacodynamics of BEZ235 Plus MEK162 in Selected Advanced Solid Tumor Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01337765 |
Recruitment Status :
Completed
First Posted : April 19, 2011
Last Update Posted : October 9, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Unspecified Adult Solid Tumor, Protocol Specific Solid Tumor | Drug: BEZ235 + MEK162 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 29 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase Ib, Open-label, Multi-center, Dose-escalation and Expansion Study of an Orally Administered Combination of BEZ235 Plus MEK162 in Adult Patients With Selected Advanced Solid Tumors |
Actual Study Start Date : | July 8, 2011 |
Actual Primary Completion Date : | March 22, 2013 |
Actual Study Completion Date : | March 22, 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: BEZ235 + MEK162 |
Drug: BEZ235 + MEK162 |
- Incidence of Dose Limiting Toxicities [ Time Frame: during Cycle 1 of treatment with BEZ235 and MEK162 ]A complete treatment cycle is defined as 28 days of daily continuois treatment with study drug combination
- Number of participants with adverse events and serious adverse events [ Time Frame: from Cycle 1 Day 1 until treatment discontinuation ]A complete treatment cycle is defined as 28 days of daily continuois treatment with study drug combination
- Overall response rate, duration of response, time to response and progression free survival [ Time Frame: every 8 weeks of treatment ]
- Time versus plasma concentration profiles of BEZ235 and MEK162 [ Time Frame: during the first cycle of treatment ]A complete treatment cycle is defined as 28 days of daily continuois treatment with study drug combination
- Treatment-induced PI3K and MEK/ERK pathway signaling inhibition and evidence of biological activity in tumor [ Time Frame: during the first cycle of treatment and at disease progression ]A complete treatment cycle is defined as 28 days of daily continuois treatment with study drug combination

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- histologically/cytologically confirmed, advanced non resectable solid tumors
- Measurable or non-measurable, but evaluable disease as determined by RECIST 1.0
Exclusion Criteria:
- Patients with primary CNS tumor or CNS tumor involvement
- Diabetes mellitus - Unacceptable ocular/retinal conditions
Other protocol-defined inclusion/exclusion criteria may apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337765
United States, Massachusetts | |
Massachusetts General Hospital Mass General 2 | |
Boston, Massachusetts, United States, 02114 | |
United States, Texas | |
University of Texas/MD Anderson Cancer Center MD Anderson PSC | |
Houston, Texas, United States, 77030-4009 | |
Australia, Victoria | |
Pfizer Investigative Site | |
Parkville, Victoria, Australia, 3050 | |
Canada, Ontario | |
Pfizer Investigative Site | |
Toronto, Ontario, Canada, M5G 2M9 | |
France | |
Pfizer Investigative Site | |
Villejuif Cedex, France, 94805 | |
Spain | |
Pfizer Investigative Site | |
Barcelona, Cataluña, Spain, 08035 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT01337765 |
Other Study ID Numbers: |
CMEK162X2103 2011-000421-74 ( EudraCT Number ) C4211009 ( Other Identifier: Pfizer ) |
First Posted: | April 19, 2011 Key Record Dates |
Last Update Posted: | October 9, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests. |
BEZ235, MEK162 RAS RAF mutations, triple negative breast cancer pancreatic cancer, |
NSCLC progressed on EGFR TKI PI3K/mTOR inhibitor, MEK inhibitor Advanced and selected solid tumors |
Neoplasms Dactolisib Antineoplastic Agents |