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OpenTrials
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NCT Number: NCT01337765

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.

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Key information

Conditions

Unspecified Adult Solid Tumor, Protocol Specific Breast Diseases Breast Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Skin Diseases Skin and Connective Tissue Diseases Solid Tumor Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigative Site, Parkville, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BEZ235 + MEK162

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Overall response rate, duration of response, time to response and progression free survival

    Time frame: every 8 weeks of treatment

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 19, 2011
Registry last updated
Oct 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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