Trial · NCT01943851
A Dose Escalation Study to Investigate the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD) and Clinical Activity of GSK525762 in Subjects With Relapsed, Refractory Hematologic Malignancies
NCT01943851, Phase 2, Completed, GlaxoSmithKline; results first posted 2021-05-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Dose Escalation Study to Investigate the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD) and Clinical Activity of GSK525762 in Subjects With Relapsed, Refractory Hematologic Malignancies. Trials, record NCT01943851. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01943851
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Dose Escalation Study to Investigate the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD) and Clinical Activity of GSK525762 in Subjects With Relapsed, Refractory Hematologic Malignancies
- NCT number
- NCT01943851
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 111 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Neoplasms
- Interventions
- GSK525762
- First posted
- 2013-09-17
- Last updated
- 2024-10-01
- Other registries' IDs
- eudract:2013-000445-39
- Results first posted
- 2021-05-19
Source ClinicalTrials.gov
Registered outcomes62
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) and AE Leading to Discontinuation (AELD) | Up to 86.9 weeks | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and SAE is defined as any untoward medical occurrence that, at any dose which results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect. AELD is adverse events leading to permanent discontinuation of study treatment. |
| Primary | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | Up to 3 weeks | An event was considered DLT if it occurred within first 3weeks of treatment \& met one of following criteria:unless it was clearly established that event is unrelated to treatment:Grade4 neutropenia persisting for \>=7 days/febrile neutropenia not responding to treatment within 24hours, Grade4 thrombocytopenia lasting more than 7day \& not responding to transfusions/Grade3 thrombocytopenia associated with bleeding (\>10milliliter \[mL\]), Drug-related Grade 3/4 non-hematologic toxicity as described in National Cancer Institute-Common Terminology Criteria for Adverse Events(NCI-CTCAE)version 4.0, Drug-related Grade2 non-hematological toxicity, Grade2 Troponin T elevation(central laboratory\>Upper Limit of Normal\[ULN\]),measured on two separate occasions within 48 hours, Treatment delay of 14 days/greater due to unresolved drug-related toxicity,ALT\>=3xULN+bilirubin\>=2xULN(\>35% direct)/Alanine aminotransferase(ALT) between 3-5xULN with bilirubin\<2xULN but with hepatitis symptom/rash/ALT\>=5xULN. |
| Primary | Part 1: Number of Participants With Dose Reductions | Up to 86.9 weeks | Number of participants with dose reductions due to any reason is presented. |
| Primary | Part 1: Number of Participants With Any Dose Interruptions or Delays | Up to 86.9 weeks | Number of participants with any dose interruptions/ delays is presented. |
| Primary | Part 1: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Up to 86.9 weeks | Blood samples were collected for the analysis of following clinical chemistry parameters: glucose, prothrombin international normalized ratio (Pro. INR), albumin, amylase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, calcium, calcium ionized, cholesterol, creatinine, creatine kinase, lipase, potassium, magnesium, sodium, triglycerides, alkaline phosphatase (ALP). Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. Higher grade indicates greater severity. An increase was defined as an increase relative to Baseline. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post Baseline with any grade increase is presented. |
| Primary | Part 1: Number of Participants With Grade Change From Baseline in Hematology Parameters | Up to 86.9 weeks | Blood samples were collected for the analysis of following hematology parameters: hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. The laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. Higher grade indicates greater severity. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post Baseline with any grade increase is presented. |
| Primary | Part 1: Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method | Up to 86.9 weeks | Urine samples were collected to assess glucose, ketones, occult blood, urine protein, and monoclonal protein (monoclonal pro). The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Any increase was defined as any increase in proportional concentrations relative to Baseline. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post Baseline with any increase is presented. |
| Primary | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to Baseline: Pulse Rate and Body Temperature | Up to 86.9 weeks | Vital signs (pulse rate and temperature) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. The clinical concern ranges were: For pulse rate (low \<60 beats per minute \[bpm\] and high \>100 bpm); For body temperature (\<=35 degrees Celsius or \>=38 degrees Celsius). Participants were counted in the worst case category that their value changed to (low, normal or high), unless there was no change in their category. Participants whose value category was unchanged, or whose value became normal, were recorded in the "To Normal or No Change" category. Participants were counted twice if the participant had values that changed "To Low" and "To High", so the percentages may not add to 100%. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. |
| Primary | Part 1: Number of Participants With Increase to Grade 3 From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Up to 86.9 weeks | DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.0. For SBP: Grade 0 (\<=120 millimeter of mercury \[mmHg\]), Grade 1 (121-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (\>=160 mmHg). For DBP: Grade 0 (\<=80 mmHg), Grade 1 (81-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (\>=100 mmHg). Higher grade indicates greater severity. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. An increase is defined as an increase in grade relative to Baseline grade. Number of participants with increase to Grade 3 from Baseline is presented. |
| Primary | Part 1: Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings (Investigator Reading) | Up to 86.9 weeks | 12-lead ECGs were recorded with the participants in a supine position using an ECG machine. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 registered outcomesOutcomes62
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 Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) and AE Leading to Discontinuation (AELD) | Up to 86.9 weeks | All Treated Population consists of all participants that received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | Up to 3 weeks | All Treated Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Dose Reductions | Up to 86.9 weeks | All Treated Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Any Dose Interruptions or Delays | Up to 86.9 weeks | All Treated Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Up to 86.9 weeks | All Treated Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Grade Change From Baseline in Hematology Parameters | Up to 86.9 weeks | All Treated Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method | Up to 86.9 weeks | All Treated Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to Baseline: Pulse Rate and Body Temperature | Up to 86.9 weeks | All Treated Population. Only those participants with data available at the specified data points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Increase to Grade 3 From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Up to 86.9 weeks | All Treated Population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings (Investigator Reading) | Up to 86.9 weeks | All Treated Population. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 outcomesResults by group1,155
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 Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) and AE Leading to Discontinuation (AELD) | Part 1: GSK525762 5 mg QD | Non-serious AEs | 1 | Participants | |
| Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) and AE Leading to Discontinuation (AELD) | Part 1: GSK525762 10 mg QD | Non-serious AEs | 1 | Participants | |
| Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) and AE Leading to Discontinuation (AELD) | Part 1: GSK525762 20 mg QD | Non-serious AEs | 1 | Participants | |
| Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) and AE Leading to Discontinuation (AELD) | Part 1: GSK525762 30 mg QD MM | Non-serious AEs | 5 | Participants | |
| Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) and AE Leading to Discontinuation (AELD) | Part 1: GSK525762 40 mg QD | Non-serious AEs | 1 | Participants | |
| Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) and AE Leading to Discontinuation (AELD) | Part 1: GSK525762 40 mg QD MM | Non-serious AEs | 4 | Participants | |
| Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) and AE Leading to Discontinuation (AELD) | Part 1: GSK525762 60 mg QD AML | Non-serious AEs | 8 | Participants | |
| Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) and AE Leading to Discontinuation (AELD) | Part 1: GSK525762 60 mg QD NHL | Non-serious AEs | 18 | Participants | |
| Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) and AE Leading to Discontinuation (AELD) | Part 1: GSK525762 60 mg QD MM | Non-serious AEs | 3 | Participants | |
| Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) and AE Leading to Discontinuation (AELD) | Part 1: GSK525762 75 mg QD AML | Non-serious AEs | 8 | Participants |
1 to 10 of 1,155Source ClinicalTrials.gov
See all 1,155 results by groupParticipant flow108
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 (Up to 86.9 Weeks) | STARTED | Part 1: GSK525762 5 mg QD | 1 | |
| Part 1 (Up to 86.9 Weeks) | STARTED | Part 1: GSK525762 10 mg QD | 1 | |
| Part 1 (Up to 86.9 Weeks) | STARTED | Part 1: GSK525762 20 mg QD | 1 | |
| Part 1 (Up to 86.9 Weeks) | STARTED | Part 1: GSK525762 30 mg QD MM | 5 | |
| Part 1 (Up to 86.9 Weeks) | STARTED | Part 1: GSK525762 40 mg QD | 1 | |
| Part 1 (Up to 86.9 Weeks) | STARTED | Part 1: GSK525762 40 mg QD MM | 4 | |
| Part 1 (Up to 86.9 Weeks) | STARTED | Part 1: GSK525762 60 mg QD AML | 8 | |
| Part 1 (Up to 86.9 Weeks) | STARTED | Part 1: GSK525762 60 mg QD NHL | 18 | |
| Part 1 (Up to 86.9 Weeks) | STARTED | Part 1: GSK525762 60 mg QD MM | 3 | |
| Part 1 (Up to 86.9 Weeks) | STARTED | Part 1: GSK525762 75 mg QD AML | 8 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 participant flowAdverse events2,826
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 | Diarrhoea | Gastrointestinal disorders | GSK525762 5 MG QD | 1 | 1 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | GSK525762 10 MG QD | 0 | 1 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | GSK525762 20 MG QD | 0 | 1 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | GSK525762 30 MG QD MM | 2 | 5 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | GSK525762 40 MG QD | 1 | 1 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | GSK525762 40 MG QD MM | 1 | 4 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | GSK525762 60 MG QD AML | 3 | 8 | 6 |
| other | Diarrhoea | Gastrointestinal disorders | GSK525762 60 MG QD NHL | 7 | 18 | 8 |
| other | Diarrhoea | Gastrointestinal disorders | GSK525762 60 MG QD MM | 0 | 3 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | GSK525762 75 MG QD AML | 4 | 8 | 4 |
1 to 10 of 2,826Source ClinicalTrials.gov
See all 2,826 adverse eventsAdverse event totals54
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GSK525762 5 MG QD | 1 | 1 |
| Total, all-cause mortality | GSK525762 10 MG QD | 0 | 1 |
| Total, all-cause mortality | GSK525762 20 MG QD | 1 | 1 |
| Total, all-cause mortality | GSK525762 30 MG QD MM | 4 | 5 |
| Total, all-cause mortality | GSK525762 40 MG QD | 0 | 1 |
| Total, all-cause mortality | GSK525762 40 MG QD MM | 3 | 4 |
| Total, all-cause mortality | GSK525762 60 MG QD AML | 7 | 8 |
| Total, all-cause mortality | GSK525762 60 MG QD NHL | 12 | 18 |
| Total, all-cause mortality | GSK525762 60 MG QD MM | 2 | 3 |
| Total, all-cause mortality | GSK525762 75 MG QD AML | 8 | 8 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36350312 | 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/NCT01943851
GET https://conductscience.org/api/trials/v1/NCT01943851/registered?page=2