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Also known as GS-5829
Alobresib · 1 trial · 1 indication
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...
Alobresib is an investigational small molecule being studied in adults with advanced solid tumors and lymphomas. It has also been evaluated in combination with exemestane or fulvestrant in adults with estrogen receptor positive breast cancer. It is not approved for any indication and remains in clinical development.
Alobresib is being developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. The company sponsored the clinical program evaluating the compound in advanced solid tumors and lymphomas, including a combination cohort in estrogen receptor positive breast cancer.
Alobresib is in Phase 1 development. The single registered trial, NCT02392611, was a Phase 1 study that has since been completed. The program enrolled 33 participants and was conducted in the United States in adults aged 18 years and older.
Alobresib has been studied in one registered clinical trial, NCT02392611, titled a study to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of Alobresib in adults with advanced solid tumors and lymphomas and in combination with exemestane or fulvestrant in adults with estrogen receptor positive breast cancer. That trial is completed.
Yes. Alobresib was formerly known as GS-5829, and the two names refer to the same investigational compound from Gilead Sciences. The registered Phase 1 trial NCT02392611 lists the drug under both names, so searches for either term point to the same asset.
No. Alobresib is an investigational small molecule and has not been approved by the FDA. Its only registered study, NCT02392611, was a completed Phase 1 trial in advanced solid tumors and lymphomas, so the compound remains in early clinical development rather than on the market.