ABT-751 (E7010) Clinical Trials

Size	Price	Qty
10mg	USD 147

Clinical Trials

Multiple Phase I, Phase II, and Phase I/II clinical trials have evaluated ABT-751, administered as monotherapy or with carboplatin or docetaxel, for advanced malignancies including relapsed or refractory neuroblastoma, non-small cell lung cancer, breast, prostate, and colorectal carcinomas, and pediatric solid tumors. Sponsored by pharmaceutical companies alongside academic and cooperative groups, these completed and terminated studies assessed safety, pharmacokinetics, and efficacy.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00436852	COMPLETED	Disseminated Neuroblastoma; Recurrent Neuroblastoma	Children's Oncology Group	2007-01	PHASE2
NCT00036959	COMPLETED	Brain and Central Nervous System Tumors; Childhood Germ Cell Tumor; Extragonadal Germ Cell Tumor; Kidney Cancer; Liver Cancer; Neuroblastoma; Ovarian Cancer; Sarcoma; Unspecified Childhood Solid Tumor, Protocol Specific	National Institutes of Health Clinical Center (CC)	2002-03	PHASE1
NCT00471718	TERMINATED	Prostate Cancer	Vanderbilt-Ingram Cancer Center	2004-01	PHASE1; PHASE2
NCT00439296	TERMINATED	Recurrent Pediatric ALL; Relapsed Pediatric ALL; Acute Lymphoblastic Leukemia; Refractory Pediatric ALL	Therapeutic Advances in Childhood Leukemia Consortium	2006-05-22	PHASE1; PHASE2
NCT00735878	TERMINATED	Non Small Cell Lung Cancer; Lung Cancer	Konstantin Dragnev	2004-09	PHASE1; PHASE2
NCT00297089	COMPLETED	Lung Cancer; NSCLC; Non-Small-Cell Lung Cancer	AbbVie (prior sponsor, Abbott)	2006-11	PHASE1; PHASE2
NCT00354562	TERMINATED	Lung Cancer; Non-Small Cell Lung Cancer	Abbott	2007-02	PHASE1; PHASE2
NCT00436852	Completed	Disseminated Neuroblastoma\|Recurrent Neuroblastoma	Children''s Oncology Group\|National Cancer Institute (NCI)	2007-01	Phase 2
NCT00047489	COMPLETED	Hematological Malignancies	M.D. Anderson Cancer Center	2002-12	PHASE1
NCT00735878	Terminated	Non Small Cell Lung Cancer\|Lung Cancer	Konstantin Dragnev\|Abbott\|Dartmouth-Hitchcock Medical Center	2004-09	Phase 1\|Phase 2
NCT00063102	COMPLETED	Breast Cancer	Abbott	2002-11	PHASE2
NCT00073138	COMPLETED	Colorectal Cancer	Abbott	2003-08	PHASE2
NCT00073151	COMPLETED	Non-Small Cell Lung Cancer	Abbott	2003-09	PHASE2
NCT00073112	COMPLETED	Renal Cell Cancer	Abbott	2003-08	PHASE2

(data from https://clinicaltrials.gov, updated on 2019-07-17)

Check the ABT-751 (E7010) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

ABT-751 selectively binds to the colchicine-binding site on β-tubulin to inhibit microtubule polymerization and disrupt tumor neovascularization, thereby halting mitotic spindle assembly and compromising blood supply. This dual antimitotic and vascular-disrupting mechanism inhibits tumor cell division and triggers apoptosis, providing a strong rationale for its clinical evaluation in advanced solid tumors such as neuroblastoma, non-small cell lung cancer, and refractory carcinomas.

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>).