Motesanib Diphosphate (AMG-706) Clinical Trials

Size	Price	Qty
10mg	USD 320
50mg	USD 970

Clinical Trials

Numerous clinical trials spanning Phase I through Phase III have evaluated motesanib diphosphate (AMG-706) across diverse oncology indications, including advanced solid tumors, non-small cell lung cancer, gastrointestinal stromal tumors, and metastatic breast, ovarian, pancreatic, and esophageal cancers. Sponsored by pharmaceutical companies such as Amgen and Takeda alongside collaborative research groups, these studies assessed the drug's safety, pharmacokinetics, and efficacy as monotherapy or in combination with standard chemotherapies. Recruitment statuses across these evaluations ranged from completed to terminated or unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00427349	COMPLETED	Gastrointestinal Carcinoid Tumor; Islet Cell Tumor; Neoplastic Syndrome	Eastern Cooperative Oncology Group	2008-11-07	PHASE2
NCT02629848	TERMINATED	Carcinoma, Non-Small-Cell Lung	Takeda	2012-07	PHASE3
NCT00574951	TERMINATED	Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer	Gynecologic Oncology Group	2007-12	PHASE2
NCT00360867	TERMINATED	Solid Tumors	Amgen	2005-12	PHASE2
NCT00460317	TERMINATED	Non-Small Cell Lung Cancer	Amgen	2007-07	PHASE3
NCT01386866	COMPLETED	Advanced Solid Tumors	Amgen	2009-05	PHASE1
NCT00101894	COMPLETED	Rectal Cancer; Colon Cancer	Amgen	2004-12	PHASE1
NCT01386866	Completed	Advanced Solid Tumors	Amgen	2009-05	Phase 1
NCT00322400	COMPLETED	Locally Recurrent and Metastatic Breast Cancer	Amgen	2006-03	PHASE1
NCT00356681	TERMINATED	Breast Neoplasms; Breast Tumors; Breast Cancer; Locally Recurrent and Metastatic Breast Cancer	Amgen	2006-12	PHASE2
NCT00448786	COMPLETED	Solid Tumors	Amgen	2007-02	PHASE1
NCT00369070	TERMINATED	Advanced Non-squamous NSCLC	Amgen	2007-01-31	PHASE2
NCT01235416	COMPLETED	Histologically or Cytologically Documented Solid Tumors	Amgen	2005-09	PHASE1
NCT00101907	TERMINATED	Lung Cancer; Pancreatic Cancer; Esophageal Cancer	Amgen	2004-12	PHASE1
NCT00094835	COMPLETED	Lung Cancer; Non-Small Cell Lung Cancer	Amgen	2005-01	PHASE1; PHASE2
NCT00448786	Completed	Solid Tumors	Amgen	2007-02	Phase 1
NCT00254267	COMPLETED	Advanced Gastrointestinal Stromal Tumor	Amgen	2005-11	PHASE2
NCT00121628	COMPLETED	Thyroid Cancer	Amgen	2005-07	PHASE2
NCT00089960	COMPLETED	Gastrointestinal Cancer	Amgen	2004-10	PHASE2
NCT00322400	Completed	Locally Recurrent and Metastatic Breast Cancer	Amgen	2006-03	Phase 1
NCT00093873	COMPLETED	Tumors	Amgen	2003-07	PHASE1
NCT01235416	Completed	Histologically or Cytologically Documented Solid Tumors	Amgen	2005-09	Phase 1
NCT00324597	UNKNOWN	Lung Cancer; Lymphoma; Lymphoproliferative Disorder; Unspecified Adult Solid Tumor, Protocol Specific	Jonsson Comprehensive Cancer Center	2005-10	PHASE1
NCT00861419	COMPLETED	Advanced Solid Tumors	Amgen	2005-12	PHASE1

(data from https://clinicaltrials.gov, updated on 2023-07-05)

Check the Motesanib Diphosphate (AMG-706) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Motesanib Diphosphate functions as an ATP-competitive inhibitor that selectively binds to vascular endothelial growth factor receptors (VEGFR1/2/3), platelet-derived growth factor receptor (PDGFR), c-Kit, and Ret, thereby blocking receptor autophosphorylation and downstream receptor tyrosine kinase signaling cascades. This biochemical blockade disrupts tumor angiogenesis and suppresses vascular endothelial and cancer cell proliferation, ultimately leading to tumor growth inhibition and vascular regression in clinical trial settings evaluating advanced solid tumors, non-small cell lung cancer, and metastatic breast cancer.

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>).