A Phase 1 interventional study of BEZ235 + MEK162 in Unspecified Adult Solid Tumor, Protocol Specific and Solid Tumor, sponsored by Pfizer. Completed at 6 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-09.
Sponsored by Pfizer · Phase 1, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 29 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
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Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Drug: BEZ235 + MEK162
Incidence of Dose Limiting Toxicities
A complete treatment cycle is defined as 28 days of daily continuois treatment with study drug combination
Time frame: during Cycle 1 of treatment with BEZ235 and MEK162
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
Time frame: from Cycle 1 Day 1 until treatment discontinuation
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
A complete treatment cycle is defined as 28 days of daily continuois treatment with study drug combination
Time frame: 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
Time frame: during the first cycle of treatment and at disease progression
Plan to share: No — 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.
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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