Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE1 | COMPLETED | 33 | — | — | Mar 16, 2015 | Oct 11, 2017 | Dec 29, 2020 | 4 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Monotherapy: Alobresib 0.6 mg | EXPERIMENTAL | Participants with advanced solid tumors and lymphomas who have failed or are intolerant to standard therapy or for whom no standard therapy exists, will receive alobresib at a dose of 0.6 mg to determine the MTD. |
| Monotherapy: Alobresib 1.4 mg | EXPERIMENTAL | Participants with advanced solid tumors and lymphomas who have failed or are intolerant to standard therapy or for whom no standard therapy exists, will receive alobresib at a dose of 1.4 mg to determine the MTD. |
| Monotherapy: Alobresib 2 mg | EXPERIMENTAL | Participants with advanced solid tumors and lymphomas who have failed or are intolerant to standard therapy or for whom no standard therapy exists, will receive alobresib at a dose of 2 mg to determine the MTD. |
| Monotherapy: Alobresib 3 mg | EXPERIMENTAL | Participants with advanced solid tumors and lymphomas who have failed or are intolerant to standard therapy or for whom no standard therapy exists, will receive alobresib at a dose of 3 mg to determine the MTD. |
| Monotherapy: Alobresib 4 mg | EXPERIMENTAL | Participants with advanced solid tumors and lymphomas who have failed or are intolerant to standard therapy or for whom no standard therapy exists, will receive alobresib at a dose of 4 mg to determine the MTD. |
| Monotherapy: Alobresib 6 mg | EXPERIMENTAL | Participants with advanced solid tumors and lymphomas who have failed or are intolerant to standard therapy or for whom no standard therapy exists, will receive alobresib at a dose of 6 mg to determine the MTD. |
| Combination Therapy: Alobresib 2 mg + Exemestane | EXPERIMENTAL | Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy exists, will receive alobresib at a dose of 2 mg in combination with exemestane 25 mg. |
| Combination Therapy: Alobresib 2 mg + Fulvestrant | EXPERIMENTAL | Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy exists, will receive alobresib at a dose of 2 mg in combination with fulvestrant 500 mg. |
| Combination Therapy: Alobresib 3 mg + Fulvestrant | EXPERIMENTAL | Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy exists, will receive alobresib at a dose of 3 mg in combination with fulvestrant 500 mg. |
| Name | Type | Description |
|---|---|---|
| Alobresib | DRUG | Tablet administered orally once daily on Study Day 1 through Cycle 1 Day 28 of 28 days cycle |
| Exemestane | DRUG | Tablets administered orally once daily on Cycle 1 Day 1 of 28 days cycle |
| Fulvestrant | DRUG | Administered intramuscularly on Cycle 1 Day 1 of 28 days cycle and every 28 days |
Key Inclusion Criteria: * Group 1: Histologically or cytologically confirmed advanced malignant solid tumor or lymphoma (any subtype) that is refractory to or intolerant of standard therapy or for which no standard therapy is available * Group 2: Post-menopausal women with advanced stage estrogen r...