Advertisement

Topics

Study of a Focal Adhesion Kinase Inhibitor in Subjects With Solid Tumors

2014-07-23 21:08:52 | BioPortfolio

Summary

This study is a Phase I dose escalation study in subjects with solid tumors. Part 1 will identify the maximum tolerated dose (MTD) using a dose-escalation procedure. Part 2 will explore further the safety, tolerability, and anti-tumor activity of GSK2256098 in subjects with tumors known to overexpress focal adhesion kinase (FAK). Part 3 will characterize the range of biologically effective doses by assessing pharmacodynamic (PD) markers in hair, skin and tumor tissue. The primary objective of this study is to determine the safety, tolerability, and MTD of GSK2256098. Secondary objectives are to characterize the pharmacokinetics (PK) of GSK2256098; to identify a range of biologically active doses; to explore the anti-tumor activity of GSK2256098; and to explore relationships between GSK2256098 PK, PD and clinical endpoints.

Description

This study is a Phase I dose escalation study in subjects with solid tumors. Part 1 will identify the maximum tolerated dose (MTD) using a dose-escalation procedure. Part 2 will explore further the safety, tolerability, and anti-tumor activity of GSK2256098 in subjects with tumors known to overexpress focal adhesion kinase (FAK). Part 3 will characterize the range of biologically effective doses by assessing pharmacodynamic (PD) markers in hair, skin and tumor tissue. The primary objective of this study is to determine the safety, tolerability, and MTD of GSK2256098. Secondary objectives are to characterize the pharmacokinetics (PK) of GSK2256098; to identify a range of biologically active doses; to explore the anti-tumor activity of GSK2256098; and to explore relationships between GSK2256098 PK, PD and clinical endpoints.

Subjects with solid tumors will receive GSK2256098 orally without interruption on consecutive days. The planned starting dose in Part 1 will be a total daily dose of 160 mg administered as 80 mg twice daily (BID) during the repeat dose phase of the study. In the first cohort, administration of study drug will be initiated as a single dose (80 mg) on Day 1 that will be followed by collection of PK samples. Subjects may then begin repeat dosing (80 mg BID) on Day 2 following the collection of the 24-h PK sample. In subsequent cohorts, administration of study drug will be given as a single dose (half the total daily dose) on Day 1 followed by collection of PK samples. Subjects may begin repeat dosing on Day 2 following collection of the 24-h PK sample.

During dose escalation (Part 1), a modified accelerated dose titration design will be followed by a standard 3+3 dose escalation design until the MTD is established. After the MTD is established approximately 30 additional subjects with tumors reported to have FAK over-expression will be enrolled to further explore the safety, tolerability and clinical activity of GSK2256098 (Part 2). Additional cohorts below the MTD may be expanded to further explore and characterize the range of biologically effective doses (Part 3).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Cancer

Intervention

GSK2256098

Status

Not yet recruiting

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:52-0400

Clinical Trials [2 Associated Clinical Trials listed on BioPortfolio]

Positron Emission Tomography (PET) Study to Evaluate Biodistribution of [11C]-GSK2256098 in Healthy Subjects and Idiopathic Pulmonary Arterial Hypertension (PAH) Patients

Pulmonary arterial hypertension (PAH) involves the narrowing of blood vessels connected to and within the lungs. Focal adhesion kinase (FAK) is a focal adhesion-associated protein kinase i...

A Dose Escalation Study to Assess Safety of GSK2256098 (FAK Inhibitor) in Combination With Trametinib (MEK Inhibitor) in Subjects With Advanced Solid Tumors

The purpose of this study is to assess the safety of combination treatment of GSK2256098 and trametinib in mesothelioma subjects and subjects with other selected tumor types. Also, the stu...

PubMed Articles [13326 Associated PubMed Articles listed on BioPortfolio]

A Study of the Focal Adhesion Kinase Inhibitor GSK2256098 in Patients with Recurrent Glioblastoma with Evaluation of Tumor Penetration of 11CGSK2256098.

GSK2256098 is a novel oral focal adhesion kinase inhibitor. Preclinical studies demonstrate growth inhibition in glioblastoma cell lines. However, rodent studies indicate limited blood-brain barrier p...

Cancer screening in the United States, 2018: A review of current American Cancer Society guidelines and current issues in cancer screening.

Each year, the American Cancer Society publishes a summary of its guidelines for early cancer detection, data and trends in cancer screening rates from the National Health Interview Survey, and select...

Behavioral Counseling to Prevent Skin Cancer: US Preventive Services Task Force Recommendation Statement.

Skin cancer is the most common type of cancer in the United States. Although invasive melanoma accounts for only 2% of all skin cancer cases, it is responsible for 80% of skin cancer deaths. Basal and...

Patterns, perceptions, and perceived barriers to physical activity in adult cancer survivors.

Physical activity (PA) during and after cancer treatment is associated with improved cancer- and non-cancer-related outcomes. We assessed for predictors of change in PA levels among cancer survivors.

Development of the Cancer Survivor Profile-Breast Cancer (CSPro-BC) app: patient and nurse perspectives on a new navigation tool.

Despite advancements in care, cancer survivors continue to report unmet needs following active cancer treatment. The Cancer Survivor Profile-Breast Cancer (CSPro-BC) application (app) was developed to...

Medical and Biotech [MESH] Definitions

A cancer registry mandated under the National Cancer Act of 1971 to operate and maintain a population-based cancer reporting system, reporting periodically estimates of cancer incidence and mortality in the United States. The Surveillance, Epidemiology, and End Results (SEER) Program is a continuing project of the National Cancer Institute of the National Institutes of Health. Among its goals, in addition to assembling and reporting cancer statistics, are the monitoring of annual cancer incident trends and the promoting of studies designed to identify factors amenable to cancer control interventions. (From National Cancer Institute, NIH Publication No. 91-3074, October 1990)

A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.

That portion of the stomach remaining after gastric surgery, usually gastrectomy or gastroenterostomy for cancer of the stomach or peptic ulcer. It is a common site of cancer referred to as stump cancer or carcinoma of the gastric stump.

A voluntary organization concerned with the prevention and treatment of cancer through education and research.

A hereditary disease characterized by multiple ectodermal, mesodermal, and endodermal nevoid and neoplastic anomalies. Facial trichilemmomas and papillomatous papules of the oral mucosa are the most characteristic lesions. Individuals with this syndrome have a high risk of BREAST CANCER; THYROID CANCER; and ENDOMETRIAL CANCER. This syndrome is associated with mutations in the gene for PTEN PHOSPHATASE.

More From BioPortfolio on "Study of a Focal Adhesion Kinase Inhibitor in Subjects With Solid Tumors"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Dermatology
Acne Dermatology Eczema Psoriasis Wound Care Dermatology is the medical specialty concerned with the diagnosis and treatment of skin disorders (Oxford Medical Dictionary). As well as studying how the skin works, dermatology covers...

Wound management
Anything that breaks the skin is a wound because when the skin is broken, there's a risk of germs getting into the body and causing an infection. Follow and track Wound Care News on BioPortfolio: Wound Car...


Searches Linking to this Trial