CompletedPhase 1

An Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK3326595 in Participants With Solid Tumors and Non-Hodgkin's Lymphoma

United States297 participantsStarted 2016-08-30

Plain-language summary

This first time in human (FTIH) open-label, dose escalation study will assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of GSK3326595 in participants with advanced or recurrent solid tumors, as well as clinical activity in participants with a subset of solid tumors and non-Hodgkin's lymphoma (NHL).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * Males and females greater than or equal to (\>=)18 years of age (at the time consent is obtained) * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 or 2 * Diagnosis of non-resectable or metastatic solid malignancy (as defined in the protocol) or NHL * Presence of evaluable disease * Adequate organ function (as defined in the protocol) * Reproductive criteria (as defined in the protocol). Exclusion Criteria: * Malignancy attributed to prior solid organ transplant * Leptomeningeal disease, spinal cord compression, or brain metastases that require immediate central nervous system (CNS)-specific treatment in the opinion of the Investigator (for example \[e.g.\], for symptomatic disease) * History of a second malignancy, excluding non-melanoma skin cell cancer within the last three years * Evidence of severe or uncontrolled systemic diseases, or serious and/or pre-existing medical or other condition that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator * Any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels. * Select cardiac abnormalities (as defined in the protocol) * History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator…

What they're measuring

Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: Up to 30 months

Part 1: Number of Participants Withdrawn Due to AEs

Timeframe: Up to 30 months

Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)

Timeframe: Up to 21 days

Part 1: Number of Participants With Dose Modifications of GSK3326595

Timeframe: Up to 30 months

Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters

Timeframe: Baseline (Day 1) and up to 30 months

Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters

Timeframe: Baseline (Day 1) and up to 30 months

Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters

Timeframe: Baseline (Day 1) and up to 30 months

Trial details

NCT IDNCT02783300

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08-30

Results submitted2024-08-28

View on ClinicalTrials.gov More Neoplasms trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: Up to 30 months

Part 1: Number of Participants Withdrawn Due to AEs

Timeframe: Up to 30 months

Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)

Timeframe: Up to 21 days

Part 1: Number of Participants With Dose Modifications of GSK3326595

Timeframe: Up to 30 months

Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters

Timeframe: Baseline (Day 1) and up to 30 months

Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters

Timeframe: Baseline (Day 1) and up to 30 months

Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters

Timeframe: Baseline (Day 1) and up to 30 months