Trotabresib (CC-90010) Clinical Trials

Size	Price	Qty
5mg	USD 289
25mg	USD 867

Clinical Trials

Multiple clinical trials evaluate trotabresib (CC-90010) as monotherapy or combined with standard regimens, focusing primarily on Phase I safety, pharmacokinetics, and CNS penetration. Sponsored by Celgene, Bristol-Myers Squibb, Northwestern University, and Dana-Farber Cancer Institute, these studies encompass indications including advanced solid tumors, glioblastoma, astrocytoma, HER2-positive breast carcinoma, pediatric hematologic and CNS malignancies, and brain or leptomeningeal metastases. Currently, these Phase I investigations are either active not recruiting or withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06137651	WITHDRAWN	Breast Carcinoma; Metastatic Malignant Neoplasm in the Brain; Metastatic Malignant Neoplasm in the Leptomeninges	Northwestern University	2023-12-31	PHASE1
NCT05678283	Withdrawn	Advanced Solid Tumors	Bristol-Myers Squibb	2023-01-09	Phase 1
NCT04324840	Active not recruiting	Glioblastoma	Celgene	2020-07-10	Phase 1
NCT04047303	Active not recruiting	Astrocytoma\|Glioblastoma	Celgene	2020-01-02	Phase 1
NCT03936465	Active not recruiting	Solid Tumor Childhood\|Lymphoma\|Brain Tumor Pediatric	Dana-Farber Cancer Institute\|Stand Up To Cancer	2019-09-27	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-04-01)

Check the Trotabresib (CC-90010) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Trotabresib (CC-90010) reversibly binds to bromodomain and extra-terminal proteins, disrupting their interaction with acetylated histones and suppressing the transcription of key oncogenic drivers. This transcriptional inhibition arrests cancer cell proliferation and promotes apoptosis, driving antitumor efficacy against advanced solid tumors, glioblastoma, and central nervous system metastases studied 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>).