Trial · NCT02392611
Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alobresib (Formerly GS-5829) in Adults With Advanced Solid Tumors and Lymphomas and in Combination With Exemestane or Fulvestrant in Adults With Estrogen Receptor Positive Breast Cancer
NCT02392611, Phase 1, Completed, Gilead Sciences; results first posted 2020-12-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alobresib (Formerly GS-5829) in Adults With Advanced Solid Tumors and Lymphomas and in Combination With Exemestane or Fulvestrant in Adults With Estrogen Receptor Positive Breast Cancer. Trials, record NCT02392611. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02392611
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alobresib (Formerly GS-5829) in Adults With Advanced Solid Tumors and Lymphomas and in Combination With Exemestane or Fulvestrant in Adults With Estrogen Receptor Positive Breast Cancer
- NCT number
- NCT02392611
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 33 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Solid Tumors and Lymphomas
- Interventions
- Alobresib, Exemestane, Fulvestrant
- First posted
- 2015-03-19
- Last updated
- 2020-12-29
- Other registries' IDs
- eudract:2016-001912-39
- Results first posted
- 2020-12-29
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | Baseline (Day 1) up to 28 days | A DLT was a toxicity, considered possibly related to alobresib, and which occurred during DLT assessment window (Day 1 through Cycle 1 Day 28) in each cohort: Grade ≥ 4 neutropenia (absolute neutrophil count \[ANC\] \< 500/mm\^3); Grade ≥3 neutropenia (ANC\< 1000/mm\^3) with fever (a single temperature of \> 38.3°C or a sustained temperature of ≥ 38°C for more than 1 hour \[hr\]); Grade ≥ 3 thrombocytopenia; Grade ≥ 2 bleeding; Grade ≥ 3 non hematologic toxicity, except Grade 3 nausea or emesis with maximum duration of 48 hrs on adequate medical therapy and Grade 3 diarrhea which persists for \< 72 hrs in absence of maximal medical therapy; Grade ≥ 2 non hematologic treatment-emergent adverse event (TEAE) of potential clinical significance; treatment interruption ≥ 7 days due to unresolved toxicity; and any Grade 3 or 4 elevation in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) associated with a Grade 2 elevation in bilirubin that is at least possibly related to alobresib. |
| Secondary | Pharmacokinetic (PK) Parameter: Cmax of Alobresib | Cycle 1: Predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hrs postdose on Days 1 and 8 (1 Cycle = 28 days) | Cmax is defined as the maximum concentration of the drug. |
| Secondary | PK Parameter: Ctau of Alobresib | Cycle 1: Predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hrs postdose on Day 8 (1 Cycle = 28 days) | Ctau is defined as the observed drug concentration at the end of the dosing interval. |
| Secondary | PK Parameter: AUC0-24 of Alobresib | Cycle 1: Predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hrs postdose on Days 1 and 8 (1 Cycle = 28 days) | AUC0-24 is defined as the concentration of drug over time from time zero to time 24 hrs. |
| Secondary | PK Parameter: AUCtau of Alobresib | Cycle 1: Predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hrs postdose on Day 8 (1 Cycle = 28 days) | AUCtau is defined as the concentration of drug over time (the area under the concentration verses time curve over the dosing interval). |
| Secondary | PK Parameter: Tmax of Alobresib | Cycle 1: Predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hrs postdose on Days 1 and 8 (1 Cycle = 28 days) | Tmax is defined as the time (observed time point) of Cmax. |
| Secondary | PK Parameter: t1/2 of Alobresib | Cycle 1: Predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hrs postdose on Days 1 and 8 (1 Cycle = 28 days) | t1/2 is defined as the estimate of the terminal elimination half-life of the drug. Due to short sampling period of the terminal elimination phase in these cohorts t1/2 values should be interpreted with caution. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | Baseline (Day 1) up to 28 days | The Full Analysis Set included all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacokinetic (PK) Parameter: Cmax of Alobresib | Cycle 1: Predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hrs postdose on Days 1 and 8 (1 Cycle = 28 days) | Participants in the PK Analysis Set (included all enrolled participants who took at least 1 dose of study drug and had at least 1 nonmissing postdose value reported by the PK laboratory) with available data were analyzed. | ng/mL | MEAN |
| SECONDARY | PK Parameter: Ctau of Alobresib | Cycle 1: Predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hrs postdose on Day 8 (1 Cycle = 28 days) | Participants in the PK Analysis Set with available data were analyzed. | ng/mL | MEAN |
| SECONDARY | PK Parameter: AUC0-24 of Alobresib | Cycle 1: Predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hrs postdose on Days 1 and 8 (1 Cycle = 28 days) | Participants in the PK Analysis Set with available data were analyzed. | h*ng/mL | MEAN |
| SECONDARY | PK Parameter: AUCtau of Alobresib | Cycle 1: Predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hrs postdose on Day 8 (1 Cycle = 28 days) | Participants in the PK Analysis Set with available data were analyzed. | h*ng/mL | MEAN |
| SECONDARY | PK Parameter: Tmax of Alobresib | Cycle 1: Predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hrs postdose on Days 1 and 8 (1 Cycle = 28 days) | Participants in the PK Analysis Set with available data were analyzed. | hour | MEDIAN |
| SECONDARY | PK Parameter: t1/2 of Alobresib | Cycle 1: Predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hrs postdose on Days 1 and 8 (1 Cycle = 28 days) | Participants in the PK Analysis Set with available data were analyzed. | hour | MEDIAN |
Source ClinicalTrials.gov
Results by group99
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | Monotherapy: Alobresib 0.6 mg | 0 | Participants | ||
| Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | Monotherapy: Alobresib 1.4 mg | 0 | Participants | ||
| Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | Monotherapy: Alobresib 2 mg | 0 | Participants | ||
| Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | Monotherapy: Alobresib 3 mg | 1 | Participants | ||
| Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | Monotherapy: Alobresib 4 mg | 1 | Participants | ||
| Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | Monotherapy: Alobresib 6 mg | 2 | Participants | ||
| Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | Combination Therapy: Alobresib 2 mg + Exemestane | 0 | Participants | ||
| Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | Combination Therapy: Alobresib 2 mg + Fulvestrant | 0 | Participants | ||
| Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | Combination Therapy: Alobresib 3 mg + Fulvestrant | 1 | Participants | ||
| Pharmacokinetic (PK) Parameter: Cmax of Alobresib | Monotherapy: Alobresib 0.6 mg | Cycle 1 Day 1 | 35.2 | Standard Deviation 7.21 | ng/mL |
1 to 10 of 99Source ClinicalTrials.gov
See all 99 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Monotherapy: Alobresib 0.6 mg | 2 | |
| Overall Study | STARTED | Monotherapy: Alobresib 1.4 mg | 1 | |
| Overall Study | STARTED | Monotherapy: Alobresib 2 mg | 1 | |
| Overall Study | STARTED | Monotherapy: Alobresib 3 mg | 9 | |
| Overall Study | STARTED | Monotherapy: Alobresib 4 mg | 6 | |
| Overall Study | STARTED | Monotherapy: Alobresib 6 mg | 4 | |
| Overall Study | STARTED | Combination Therapy: Alobresib 2 mg + Exemestane | 4 | |
| Overall Study | STARTED | Combination Therapy: Alobresib 2 mg + Fulvestrant | 3 | |
| Overall Study | STARTED | Combination Therapy: Alobresib 3 mg + Fulvestrant | 3 | |
| Overall Study | COMPLETED | Monotherapy: Alobresib 0.6 mg | 1 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events927
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 | Anaemia | Blood and lymphatic system disorders | Monotherapy: Alobresib 0.6 mg | 1 | 2 | |
| other | Anaemia | Blood and lymphatic system disorders | Monotherapy: Alobresib 1.4 mg | 0 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | Monotherapy: Alobresib 2 mg | 0 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | Monotherapy: Alobresib 3 mg | 1 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | Monotherapy: Alobresib 4 mg | 0 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Monotherapy: Alobresib 6 mg | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Combination Therapy: Alobresib 2 mg + Exemestane | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Combination Therapy: Alobresib 2 mg + Fulvestrant | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Combination Therapy: Alobresib 3 mg + Fulvestrant | 1 | 3 | |
| other | Neutropenia | Blood and lymphatic system disorders | Monotherapy: Alobresib 0.6 mg | 0 | 2 |
1 to 10 of 927Source ClinicalTrials.gov
See all 927 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Monotherapy: Alobresib 0.6 mg | 1 | 2 |
| Total, all-cause mortality | Monotherapy: Alobresib 1.4 mg | 0 | 1 |
| Total, all-cause mortality | Monotherapy: Alobresib 2 mg | 0 | 1 |
| Total, all-cause mortality | Monotherapy: Alobresib 3 mg | 1 | 7 |
| Total, all-cause mortality | Monotherapy: Alobresib 4 mg | 0 | 6 |
| Total, all-cause mortality | Monotherapy: Alobresib 6 mg | 1 | 4 |
| Total, all-cause mortality | Combination Therapy: Alobresib 2 mg + Exemestane | 1 | 4 |
| Total, all-cause mortality | Combination Therapy: Alobresib 2 mg + Fulvestrant | 0 | 3 |
| Total, all-cause mortality | Combination Therapy: Alobresib 3 mg + Fulvestrant | 0 | 3 |
| Total, other adverse events | Monotherapy: Alobresib 0.6 mg | 2 | 2 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02392611
GET https://conductscience.org/api/trials/v1/NCT02392611/results?page=2