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2011-07-08
2013-03-22
2013-03-22
29
NCT01337765
Pfizer
Pfizer
INTERVENTIONAL
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 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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2011-04-02 | N/A | 2020-10-07 |
2011-04-15 | N/A | 2020-10-09 |
2011-04-19 | N/A | 2020-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: BEZ235 + MEK162 | DRUG: BEZ235 + MEK162 |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Incidence of Dose Limiting Toxicities | A complete treatment cycle is defined as 28 days of daily continuois treatment with study drug combination | during Cycle 1 of treatment with BEZ235 and MEK162 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of participants with adverse events and serious adverse events | A complete treatment cycle is defined as 28 days of daily continuois treatment with study drug combination | from Cycle 1 Day 1 until treatment discontinuation |
| Overall response rate, duration of response, time to response and progression free survival | every 8 weeks of treatment | |
| Time versus plasma concentration profiles of BEZ235 and MEK162 | A complete treatment cycle is defined as 28 days of daily continuois treatment with study drug combination | during the first cycle of treatment |
| Treatment-induced PI3K and MEK/ERK pathway signaling inhibition and evidence of biological activity in tumor | A complete treatment cycle is defined as 28 days of daily continuois treatment with study drug combination | during the first cycle of treatment and at disease progression |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
