Alobresib (GS-5829) Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 247

Clinical Trials

Alobresib (GS-5829) has been evaluated across several clinical trials sponsored by Gilead Sciences, focusing on solid tumors, lymphomas, metastatic castrate-resistant prostate cancer, and advanced estrogen receptor-positive, HER2-negative breast cancer. Conducted as Phase 1 and Phase 1/2 studies, these trials assessed the compound as monotherapy and in combination with endocrine therapies such as fulvestrant or exemestane. Recruitment across these programs has ended, encompassing completed trials alongside early-terminated studies in prostate and breast malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02983604	TERMINATED	Advanced Estrogen Receptor Positive HER2- Breast Cancer	Gilead Sciences	2017-01-10	PHASE1; PHASE2
NCT02607228	TERMINATED	Metastatic Castrate-Resistant Prostate Cancer	Gilead Sciences	2015-12-08	PHASE1; PHASE2
NCT02392611	COMPLETED	Solid Tumors and Lymphomas	Gilead Sciences	2015-03-16	PHASE1
NCT02983604	Terminated	Advanced Estrogen Receptor Positive HER2- Breast Cancer	Gilead Sciences	2017-01-10	Phase 1\|Phase 2
NCT02607228	Terminated	Metastatic Castrate-Resistant Prostate Cancer	Gilead Sciences	2015-12-08	Phase 1\|Phase 2
NCT02392611	Completed	Solid Tumors and Lymphomas	Gilead Sciences	2015-03-16	Phase 1

(data from https://clinicaltrials.gov, updated on 2019-08-07)

Check the Alobresib (GS-5829) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Alobresib (GS-5829) selectively binds to bromodomain and extra-terminal domain (BET) proteins, disrupting chromatin binding and downregulating key oncogenic signaling cascades, including the MYC, AKT, ERK1/2, BLK, and NF-κB pathways. This targeted biochemical inhibition suppresses cell proliferation and induces robust apoptosis, mediating antitumor activity across solid tumors, lymphomas, and advanced hormone-receptor-positive malignancies evaluated in clinical trials.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).