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Brief Title: Dose Escalation Study of GSK3326595 in Subjects With Solid Tumors and Non-Hodgkin’s Lymphoma

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

INTRODUCTION

  • Org Study ID: 204653
  • Secondary ID: N/A
  • NCT ID: NCT02783300
  • Sponsor: GlaxoSmithKline

BRIEF 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).

  • Overall Status
    Completed
  • Start Date
    August 30, 2016
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

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

Primary Outcome 1 - Timeframe: Up to 30 months

Primary Outcome 2 - Measure: Part 1: Number of Participants Withdrawn Due to AEs

Primary Outcome 2 - Timeframe: Up to 30 months

Primary Outcome 3 - Measure: Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)

Primary Outcome 3 - Timeframe: Up to 21 days

Primary Outcome 4 - Measure: Part 1: Number of Participants With Dose Modifications of GSK3326595

Primary Outcome 4 - Timeframe: Up to 30 months

Primary Outcome 5 - Measure: Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters

Primary Outcome 5 - Timeframe: Baseline (Day 1) and up to 30 months

Primary Outcome 6 - Measure: Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters

Primary Outcome 6 - Timeframe: Baseline (Day 1) and up to 30 months

Primary Outcome 7 - Measure: Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters

Primary Outcome 7 - Timeframe: Baseline (Day 1) and up to 30 months

Primary Outcome 8 - Measure: Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters

Primary Outcome 8 - Timeframe: Baseline (Day 1) and up to 30 months

Primary Outcome 9 - Measure: Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH)

Primary Outcome 9 - Timeframe: Baseline (Day 1) and up to week 132

Primary Outcome 10 - Measure: Part 1: Changes From Baseline in Urine Specific Gravity

Primary Outcome 10 - Timeframe: Baseline (Day 1) and up to week 132

Primary Outcome 11 - Measure: Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs

Primary Outcome 11 - Timeframe: Baseline (Day 1) and up to 30 months

Primary Outcome 12 - Measure: Part 3: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)

Primary Outcome 12 - Timeframe: Up to 10 months

Primary Outcome 13 - Measure: Part 3: Number of Participants Withdrawn Due to AEs

Primary Outcome 13 - Timeframe: Up to 10 months

Primary Outcome 14 - Measure: Part 3: Number of Participants With Dose Modifications of GSK3326595 and Pembrolizumab

Primary Outcome 14 - Timeframe: Up to 10 months

Primary Outcome 15 - Measure: Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters

Primary Outcome 15 - Timeframe: Baseline (Day 1) and up to 10 months

Primary Outcome 16 - Measure: Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters

Primary Outcome 16 - Timeframe: Baseline (Day 1) and up to 10 months

Primary Outcome 17 - Measure: Part 3: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters

Primary Outcome 17 - Timeframe: Baseline (Day 1) and up to 10 months

Primary Outcome 18 - Measure: Part 3: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters

Primary Outcome 18 - Timeframe: Baseline (Day 1) and up to 10 months

Primary Outcome 19 - Measure: Part 3: Changes From Baseline in Urine Potential of Hydrogen (pH)

Primary Outcome 19 - Timeframe: Baseline (Day 1) and up to Week 42

Primary Outcome 20 - Measure: Part 3: Changes From Baseline in Urine Specific Gravity

Primary Outcome 20 - Timeframe: Baseline (Day 1) and up to Week 42

Primary Outcome 21 - Measure: Part 3: Number of Participants With Maximum Worst-case Increase Post-baseline Relative to Baseline in Vital Signs

Primary Outcome 21 - Timeframe: Baseline (Day 1) and up to 10 months

CONDITION

  • Neoplasms

ELIGIBILITY

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 or Medical Monitor, contraindicates their participation.

- * History of optic nerve neuropathy or neuritis.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: GSK Clinical Trials

Role: Study Director

Affiliation: GlaxoSmithKline

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact