Trial · NCT02783300
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
NCT02783300, Phase 1, Completed, GlaxoSmithKline; results first posted 2025-03-10
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. 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. Trials, record NCT02783300. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02783300
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT02783300
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 297 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Neoplasms
- Interventions
- GSK3326595, Pembrolizumab
- First posted
- 2016-05-26
- Last updated
- 2025-03-10
- Other registries' IDs
- eudract:2016-000278-39
- Results first posted
- 2025-03-10
- Limitations and caveats
- Data was not available for pharmacokinetic parameters in samples that were out of stability or lost in transit.
Source ClinicalTrials.gov
Registered outcomes66
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 30 months | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. A summary of number of participants with any AEs and SAEs is presented. AEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary). |
| Primary | Part 1: Number of Participants Withdrawn Due to AEs | Up to 30 months | The data for number of participants withdrawn due to AEs have been presented. |
| Primary | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | Up to 21 days | DLT is considered to be clinically relevant AE by investigator if it met at least one of the criteria: Grade(G)3 neutropenia for \>=5 days/G4 neutropenia of any duration, G3 or greater febrile neutropenia, G4 or greater anemia of any duration and thrombocytopenia, or G3 thrombocytopenia with bleeding, Alanine aminotransferase (ALT) \>3x upper limit of normal (ULN)+bilirubin, \>=2xULN or ALT between 3-5 X ULN with bilirubin \< 2Xuln but with hepatitis symptoms/rash, G3 nausea/vomiting/diarrhea that does not improve within 72 hour, G4 or greater nausea/vomiting/diarrhea, G3 or greater hypertension, G3 or greater clinically significant non-hematologic toxicity per National Cancer Institute -- Common Terminology Criteria for Adverse Events (NCICTCAE), Inability to receive at least 80% of scheduled doses in the DLT observation period due to toxicity, G2 or higher toxicity that occurs beyond 21 days which in the judgment of the investigator and GSK Medical Monitor was considered to be a DLT. |
| Primary | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Up to 30 months | The number of participants who experienced any dose modifications (interruptions and reductions) of GSK3326595 have been presented. |
| Primary | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Baseline (Day 1) and up to 30 months | Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%. |
| Primary | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Baseline (Day 1) and up to 30 months | Blood samples were collected for evaluation of hematology parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%. |
| Primary | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Baseline (Day 1) and up to 30 months | Blood samples were collected for evaluation of coagulation parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v4.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%. |
| Primary | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Baseline (Day 1) and up to 30 months | Urine samples were collected for evaluation of urinalysis parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with no change or change to negative and change to positive have been presented. |
| Primary | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline (Day 1) and up to week 132 | Urine samples were collected from participants to assess urine pH levels. |
| Primary | Part 1: Changes From Baseline in Urine Specific Gravity | Baseline (Day 1) and up to week 132 | Urine samples were collected from participants to assess urine specific gravity. |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 registered outcomesOutcomes66
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 30 months | All treated population included all participants who received at least one dose of GSK3326595. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants Withdrawn Due to AEs | Up to 30 months | All treated population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | Up to 21 days | All treated population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Up to 30 months | All treated population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Baseline (Day 1) and up to 30 months | All treated population. Only those participants with data available at specified categories have been analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Baseline (Day 1) and up to 30 months | All treated population. Only those participants with data available at specified categories have been analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Baseline (Day 1) and up to 30 months | All treated population. Only those participants with data available at specified categories have been analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Baseline (Day 1) and up to 30 months | All treated population. Only those participants with data available at specified categories have been analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline (Day 1) and up to week 132 | All treated population. Only those participants with data available at specified timepoint have been analyzed. | Potential of Hydrogen (pH) | MEAN |
| PRIMARY | Part 1: Changes From Baseline in Urine Specific Gravity | Baseline (Day 1) and up to week 132 | All treated population. Only those participants with data available at specified timepoint have been analyzed. | Ratio | MEAN |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 outcomesResults by group4,790
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Any AEs | 1 | Participants | |
| Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Part 1: GSK3326595 25mg QD | Any AEs | 1 | Participants | |
| Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Part 1: GSK3326595 50mg QD | Any AEs | 1 | Participants | |
| Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Part 1: GSK3326595 100mg QD | Any AEs | 1 | Participants | |
| Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Part 1: GSK3326595 200mg QD | Any AEs | 7 | Participants | |
| Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Part 1: GSK3326595 300mg QD | Any AEs | 3 | Participants | |
| Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Part 1: GSK3326595 400mg QD | Any AEs | 19 | Participants | |
| Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Part 1: GSK3326595 600mg QD | Any AEs | 3 | Participants | |
| Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Part 1: GSK3326595 50mg Twice Daily (BID) | Any AEs | 1 | Participants | |
| Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Part 1: GSK3326595 100mg BID | Any AEs | 7 | Participants |
1 to 10 of 4,790Source ClinicalTrials.gov
See all 4,790 results by groupParticipant flow243
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1- Dose Escalation Phase | STARTED | Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | 1 | |
| Part 1- Dose Escalation Phase | STARTED | Part 1: GSK3326595 25mg QD | 1 | |
| Part 1- Dose Escalation Phase | STARTED | Part 1: GSK3326595 50mg QD | 1 | |
| Part 1- Dose Escalation Phase | STARTED | Part 1: GSK3326595 100mg QD | 1 | |
| Part 1- Dose Escalation Phase | STARTED | Part 1: GSK3326595 200mg QD | 8 | |
| Part 1- Dose Escalation Phase | STARTED | Part 1: GSK3326595 300mg QD | 3 | |
| Part 1- Dose Escalation Phase | STARTED | Part 1: GSK3326595 400mg QD | 19 | |
| Part 1- Dose Escalation Phase | STARTED | Part 1: GSK3326595 600mg QD | 3 | |
| Part 1- Dose Escalation Phase | STARTED | Part 1: GSK3326595 50mg Twice Daily (BID) | 1 | |
| Part 1- Dose Escalation Phase | STARTED | Part 1: GSK3326595 100mg BID | 7 |
1 to 10 of 243Source ClinicalTrials.gov
See all 243 participant flowAdverse events5,400
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | 1 | 1 | 1 |
| other | Fatigue | General disorders | Part 1: GSK3326595 25mg QD | 0 | 1 | 0 |
| other | Fatigue | General disorders | Part 1: GSK3326595 50mg QD | 0 | 1 | 0 |
| other | Fatigue | General disorders | Part 1: GSK3326595 100mg QD | 0 | 1 | 0 |
| other | Fatigue | General disorders | Part 1: GSK3326595 200mg QD | 2 | 8 | 2 |
| other | Fatigue | General disorders | Part 1: GSK3326595 300mg QD | 2 | 3 | 2 |
| other | Fatigue | General disorders | Part 1: GSK3326595 400mg QD | 10 | 19 | 13 |
| other | Fatigue | General disorders | Part 1: GSK3326595 600mg QD | 2 | 3 | 2 |
| other | Fatigue | General disorders | Part 1: GSK3326595 50mg Twice Daily (BID) | 1 | 1 | 2 |
| other | Fatigue | General disorders | Part 1: GSK3326595 100mg BID | 2 | 7 | 2 |
1 to 10 of 5,400Source ClinicalTrials.gov
See all 5,400 adverse eventsAdverse event totals81
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | 1 | 1 |
| Total, all-cause mortality | Part 1: GSK3326595 25mg QD | 1 | 1 |
| Total, all-cause mortality | Part 1: GSK3326595 50mg QD | 1 | 1 |
| Total, all-cause mortality | Part 1: GSK3326595 100mg QD | 0 | 1 |
| Total, all-cause mortality | Part 1: GSK3326595 200mg QD | 7 | 8 |
| Total, all-cause mortality | Part 1: GSK3326595 300mg QD | 3 | 3 |
| Total, all-cause mortality | Part 1: GSK3326595 400mg QD | 13 | 19 |
| Total, all-cause mortality | Part 1: GSK3326595 600mg QD | 3 | 3 |
| Total, all-cause mortality | Part 1: GSK3326595 50mg Twice Daily (BID) | 1 | 1 |
| Total, all-cause mortality | Part 1: GSK3326595 100mg BID | 6 | 7 |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40935292 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02783300
GET https://conductscience.org/api/trials/v1/NCT02783300/registered?page=2