Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 for the treatment of advanced solid tumors and lymphomas. It is in Phase 1 clinical development and has been evaluated in a completed clinical trial involving adult patients with these conditions.
Alobresib is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol GILD. The drug is currently in Phase 1 clinical development for oncology indications.
Alobresib is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 clinical trial evaluating the drug has been completed.
Alobresib has been studied in one clinical trial, identified as NCT02392611. This Phase 1 study evaluated the 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. The trial has been completed.
Yes, Alobresib was formerly known as GS-5829. The clinical trial NCT02392611 refers to the drug as Alobresib (Formerly GS-5829), confirming that these names refer to the same investigational compound.