Clinical Trials

Multiple Phase I through Phase III clinical trials have evaluated motesanib for advanced solid tumors, non-small cell lung cancer, metastatic breast cancer, and recurrent ovarian or fallopian tube carcinomas. Sponsored by industry partners like Amgen and Takeda alongside academic cooperative groups including the Gynecologic Oncology Group and Eastern Cooperative Oncology Group, these studies yielded varied outcomes. Although several trials focusing on safety, metabolism, and combination therapies were successfully completed, others evaluating persistent gynecologic cancers were terminated or withdrawn prematurely.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01349088 WITHDRAWN
Breast Cancer; Metastatic Breast Cancer; Stage IV Breast Cancer
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
 2013-12 PHASE1; PHASE2
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
NCT01349088 Withdrawn
Breast Cancer|Metastatic Breast Cancer|Stage IV Breast Cancer
Sidney Kimmel Cancer Center at Thomas Jefferson University|Susan G. Komen Breast Cancer Foundation|Amgen|Thomas Jefferson University
 2013-12 Phase 1|Phase 2
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
NCT00254267 COMPLETED
Advanced Gastrointestinal Stromal Tumor
Amgen
 2005-11 PHASE2
NCT00448786 Completed
Solid Tumors
Amgen
 2007-02 Phase 1
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
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 2025-05-02)

Check the Motesanib (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 selectively binds to receptor tyrosine kinases including VEGFR1, VEGFR2, VEGFR3, Kit, and PDGFR, thereby blocking receptor autophosphorylation and suppressing downstream angiogenic signaling cascades. Consequently, this cellular inhibition disrupts endothelial cell proliferation and capillary tube formation, leading to suppressed tumor vascularization and tumor growth inhibition in clinical conditions such as advanced solid tumors, non-small cell lung cancer, and 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>).

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Note: Technical data last updated: Sep 1, 2026.