Trial · NCT01587703
A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects With NUT Midline Carcinoma (NMC) and Other Cancers
NCT01587703, Phase 1, Completed, GlaxoSmithKline; results first posted 2020-03-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects With NUT Midline Carcinoma (NMC) and Other Cancers. Trials, record NCT01587703. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01587703
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects With NUT Midline Carcinoma (NMC) and Other Cancers
- NCT number
- NCT01587703
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 196 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Carcinoma, Midline
- Interventions
- GSK525762
- First posted
- 2012-04-30
- Last updated
- 2020-03-16
- Other registries' IDs
- eudract:2014-004982-25
- Results first posted
- 2020-03-16
Source ClinicalTrials.gov
Registered outcomes80
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 QD | Median of 1.38 months of drug exposure | An AE is 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. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; any new primary cancers; significant cardiac dysfunction; Grade 4 laboratory abnormalities; and drug related hepatobiliary event leading to permanent discontinuation of study treatment. All Treated Population comprised of all participants who received at least one dose of study treatment. |
| Primary | Number of Participants With AEs and SAEs-Part 1 BID | Median of 1.41 months of drug exposure | An AE is 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. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; any new primary cancers; significant cardiac dysfunction; Grade 4 laboratory abnormalities; and drug related hepatobiliary event leading to permanent discontinuation of study treatment |
| Primary | Number of Participants With AEs and SAEs-Part 2 | Median of 1.41 months of drug exposure | An AE is 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. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; any new primary cancers; significant cardiac dysfunction; Grade 4 laboratory abnormalities; and drug related hepatobiliary event leading to permanent discontinuation of study treatment. |
| Primary | Number of Participants With Dose Reductions or Delays-Part 1 QD | Median of 1.38 months of drug exposure | The number of participants who had any dose reductions or delays is presented. |
| Primary | Number of Participants With Dose Reductions or Delays-Part 1 BID | Median of 1.41 months of drug exposure | The number of participants who had any dose reductions or delays is presented. |
| Primary | Number of Participants With Dose Reductions or Delays-Part 2 | Median of 1.41 months of drug exposure | The number of participants who had any dose reductions or delays is presented. |
| Primary | Number of Participants With Dose Reductions or Delays-Besylate Sub-study | Median of 1.87 months of drug exposure | The number of participants who had any dose reductions or delays is presented. |
| Primary | Number of Participants Withdrawn Due to Toxicities-Part 1 QD | Median of 1.38 months of drug exposure | Number of participants withdrawn due to toxicities is presented. |
| Primary | Number of Participants Withdrawn Due to Toxicities-Part 1 BID | Median of 1.41 months of drug exposure | Number of participants withdrawn due to toxicities is presented. |
| Primary | Number of Participants Withdrawn Due to Toxicities-Part 2 | Median of 1.41 months of drug exposure | Number of participants withdrawn due to toxicities is presented. |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 registered outcomesOutcomes80
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 QD | Median of 1.38 months of drug exposure | All Treated Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With AEs and SAEs-Part 1 BID | Median of 1.41 months of drug exposure | All Treated Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With AEs and SAEs-Part 2 | Median of 1.41 months of drug exposure | All Treated Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Dose Reductions or Delays-Part 1 QD | Median of 1.38 months of drug exposure | All Treated Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Dose Reductions or Delays-Part 1 BID | Median of 1.41 months of drug exposure | All Treated Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Dose Reductions or Delays-Part 2 | Median of 1.41 months of drug exposure | All Treated Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Dose Reductions or Delays-Besylate Sub-study | Median of 1.87 months of drug exposure | All Treated Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Withdrawn Due to Toxicities-Part 1 QD | Median of 1.38 months of drug exposure | All Treated Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Withdrawn Due to Toxicities-Part 1 BID | Median of 1.41 months of drug exposure | All Treated Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Withdrawn Due to Toxicities-Part 2 | Median of 1.41 months of drug exposure | All Treated Population | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 outcomesResults by group3,672
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 QD | Part 1: GSK525762 2 mg QD | Any AE | 3 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 QD | Part 1: GSK525762 4 mg QD | Any AE | 4 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 QD | Part 1: GSK525762 8 mg QD | Any AE | 1 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 QD | Part 1: GSK525762 16 mg QD | Any AE | 3 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 QD | Part 1: GSK525762 30 mg QD | Any AE | 3 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 QD | Part 1: GSK525762 60 mg QD | Any AE | 9 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 QD | Part 1: GSK525762 80 mg QD | Any AE | 31 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 QD | Part 1: GSK525762 100 mg QD | Any AE | 9 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 QD | Part 1: GSK525762 2 mg QD | Any SAE | 0 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 QD | Part 1: GSK525762 4 mg QD | Any SAE | 2 | Participants |
1 to 10 of 3,672Source ClinicalTrials.gov
See all 3,672 results by groupParticipant flow399
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part1 QD(Median Exposure of 1.38months) | STARTED | Part 1: GSK525762 2 mg QD | 3 | |
| Part1 QD(Median Exposure of 1.38months) | STARTED | Part 1: GSK525762 4 mg QD | 4 | |
| Part1 QD(Median Exposure of 1.38months) | STARTED | Part 1: GSK525762 8 mg QD | 1 | |
| Part1 QD(Median Exposure of 1.38months) | STARTED | Part 1: GSK525762 16 mg QD | 3 | |
| Part1 QD(Median Exposure of 1.38months) | STARTED | Part 1: GSK525762 30 mg QD | 4 | |
| Part1 QD(Median Exposure of 1.38months) | STARTED | Part 1: GSK525762 60 mg QD | 9 | |
| Part1 QD(Median Exposure of 1.38months) | STARTED | Part 1: GSK525762 80 mg QD | 32 | |
| Part1 QD(Median Exposure of 1.38months) | STARTED | Part 1: GSK525762 100 mg QD | 9 | |
| Part1 QD(Median Exposure of 1.38months) | STARTED | Part 1: GSK525762 20 mg BID | 0 | |
| Part1 QD(Median Exposure of 1.38months) | STARTED | Part 1: GSK525762 30 mg BID | 0 |
1 to 10 of 399Source ClinicalTrials.gov
See all 399 participant flowAdverse events8,512
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 | Abdominal discomfort | Gastrointestinal disorders | Part1: GSK525762 4 mg QD | 0 | 4 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Part 1: GSK525762 8 mg QD | 0 | 1 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Part 1: GSK525762 16 mg QD | 0 | 3 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Part 1: GSK525762 30 mg QD | 0 | 4 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Part 1: GSK525762 60 mg QD | 0 | 9 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Part 1: GSK525762 80 mg QD | 0 | 32 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Part 1: GSK525762 100 mg QD | 0 | 9 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Part 1: GSK525762 20 mg BID | 0 | 4 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Part 1: GSK525762 30 mg BID | 0 | 10 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Part 1: GSK525762 40 mg BID | 0 | 5 | 0 |
1 to 10 of 8,512Source ClinicalTrials.gov
See all 8,512 adverse eventsAdverse event totals57
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part1: GSK525762 4 mg QD | 4 | 4 |
| Total, all-cause mortality | Part 1: GSK525762 8 mg QD | 1 | 1 |
| Total, all-cause mortality | Part 1: GSK525762 16 mg QD | 3 | 3 |
| Total, all-cause mortality | Part 1: GSK525762 30 mg QD | 4 | 4 |
| Total, all-cause mortality | Part 1: GSK525762 60 mg QD | 7 | 9 |
| Total, all-cause mortality | Part 1: GSK525762 80 mg QD | 30 | 32 |
| Total, all-cause mortality | Part 1: GSK525762 100 mg QD | 7 | 9 |
| Total, all-cause mortality | Part 1: GSK525762 20 mg BID | 1 | 4 |
| Total, all-cause mortality | Part 1: GSK525762 30 mg BID | 9 | 10 |
| Total, all-cause mortality | Part 1: GSK525762 40 mg BID | 3 | 5 |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes vs 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes: Number of Participants With PSA50 Response-Besylate Sub-study | Trial comparisons |
| 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes vs 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes: Number of Participants With Dose Reductions or Delays-Besylate Sub-study | Trial comparisons |
| 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes vs 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes: Number of Participants Withdrawn Due to Toxicities-Besylate Sub-study | Trial comparisons |
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/NCT01587703
GET https://conductscience.org/api/trials/v1/NCT01587703/registered?page=2