Dose-Escalation Study of GSK2126458

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2015-03-31

Brief Summary

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P3K112826 is a Phase I, first-time-in-human dose escalation study in subjects with refractory malignancy. The primary objective of this study is to determine the recommended Phase II dose of GSK2126458 based on safety and tolerability, pharmacokinetics, pharmacodynamics and preliminary evidence of clinical activity. Secondary objectives are to characterize the pharmacokinetics of GSK2126458; and to explore relationships between GSK2126458 pharmacokinetics, pharmacodynamics, response prediction biomarkers and clinical endpoints.

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Detailed Description

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This study is a Phase I, first-time-in-human dose escalation study in subjects with refractory solid tumors or lymphoma. The primary objective of this study is to determine the recommended Phase II dose of GSK2126458 based on safety and tolerability, pharmacokinetics, pharmacodynamics and preliminary evidence of clinical activity. Secondary objectives are to characterize the pharmacokinetics of GSK2126458; and to explore relationships between GSK2126458 pharmacokinetics, pharmacodynamics, response prediction biomarkers and clinical endpoints.

Subjects with solid tumors or lymphoma will initially receive oral GSK2126458 daily for 28 consecutive days in each 28 day cycle. Subjects may be dosed once or twice a day or may be dosed on an intermittent schedule depending on the safety, pharmacokinetic and pharmacodynamic results that become available as the study progresses. The starting dose will be 0.1 mg once a day. Expansion of some cohorts will be conducted to test tumor pharmacodynamics, further explore the toxicity profile and to look for preliminary evidence of activity in subjects with tumors with PIK3CA mutations. The recommended Phase II dose will be the lowest dose explored (at or below MTD) that maintains biologic activity with an acceptable tolerability profile.

Conditions

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Solid Tumours

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GSK2126458

GSK2126458 will be dosed continuously (every day) for the duration a 28 day cycle. The 28 day cycles will continue until the subjects withdraw from the study.

Group Type EXPERIMENTAL

GSK2126458

Intervention Type DRUG

GSK2126458 is an experimental treatment for patients with cancer.

Interventions

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GSK2126458

GSK2126458 is an experimental treatment for patients with cancer.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically- or cytologically- confirmed diagnosis of solid tumor malignancy, or lymphoma
* Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
* Female or male that is willing to take measures to avoid pregnancy in self or a partner, including abstinence, or double barrier method.
* Adequate organ system function

Exclusion Criteria

* Use of an investigational anti-cancer medication within 28 days or 5 half-lives preceding the first dose of GSK2126458.
* Chemotherapy within the last 3 weeks (6 weeks for prior nitrosourea or mitomycin C
* Any major surgery, radiotherapy, or immunotherapy within the last 4 weeks.
* Prior use of any PI3K inhibitor.
* Current use of a prohibited medication or requires any of these medications during treatment with GSK2126458.
* Presence of an active gastrointestinal disease or other condition known to interfere significantly with the absorption, distribution, metabolism, or excretion of drugs.
* Unresolved toxicity greater than Grade 1 from previous anti-cancer therapy except alopecia.
* QTc interval ≥ 480 msecs.
* History of acute coronary syndromes; Class II, III, or IV heart failure; stroke or subarachnoid hemorrhage.
* Systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg.
* Previously diagnosed Type 1 diabetes mellitus. Subjects with Type 2 diabetes are prohibited in the dose escalation part of the study.
* Symptomatic or untreated leptomeningeal or brain metastases.
* Primary malignancy of the central nervous system.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

San Francisco, California, United States

Site Status

GSK Investigational Site

New Brunswick, New Jersey, United States

Site Status

GSK Investigational Site

Chapel Hill, North Carolina, United States

Site Status

GSK Investigational Site

Dallas, Texas, United States

Site Status

GSK Investigational Site

Houston, Texas, United States

Site Status

GSK Investigational Site

Salt Lake City, Utah, United States

Site Status

GSK Investigational Site

Seattle, Washington, United States

Site Status

GSK Investigational Site

Amsterdam, , Netherlands

Site Status

GSK Investigational Site

Utrecht, , Netherlands

Site Status

Countries

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United States Netherlands

Study Documents

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