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OpenTrials
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NCT Number: NCT01363232

Safety, Pharmacokinetics and Pharmacodynamics of BKM120 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 the recommended phase II dose (RP2D) of the orally administered phosphatidylinositol 3'-kinase (PI3K) inhibitor BKM120 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (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 BKM120 and MEK162.

Study drugs will be administered once daily orally on a continuous schedule. A treatment cycle is defined as 28 days.

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Key information

Conditions

Advanced Solid Tumors Adnexal Diseases Breast Diseases Breast Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Pancreatic Diseases Pancreatic Neoplasms Selected Solid Tumors Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigative Site, Toronto, Ontario, Canada

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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

Exclusion criteria

  • Patients with primary CNS tumor or CNS tumor involvement.
  • Diabetes mellitus
  • Unacceptable ocular/retinal conditions

Treatment and study plan

BKM120 + MEK162

Drug

Primary outcomes

  1. Incidence of Dose Limiting Toxicities

    Time frame: during Cycle 1 of treatment with BKM120 and MEK162

Secondary outcomes

  1. Number of participants with adverse events and serious adverse events.

    Time frame: from Cycle 1 Day 1 until treatment discontinuation

  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 BKM120 and MEK162

    Time frame: during the first cycle of treatment on Cycle 1 Day 1 and Cycle 1 Day 15

  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 on Cycle 1 Day 15 and at disease progression

Sponsors and collaborators

Lead sponsor

Array Biopharma, now a wholly owned subsidiary of 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 BKM120 Plus MEK162 in Adult Patients With Selected Advanced Solid Tumors

Important dates

Study start
2011
Primary completion
2014
Study completion
2017
First posted
Jun 1, 2011
Registry last updated
Oct 5, 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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