Clinical Trials

Cilengitide has been evaluated in numerous Phase I through Phase III clinical trials targeting diverse oncological indications, including glioblastoma, non-small-cell lung carcinoma, metastatic prostate cancer, melanoma, acute myeloid leukemia, and lymphomas. Sponsored by the National Cancer Institute, Merck KGaA, EMD Serono, and academic institutions, these investigations encompass completed, terminated, and withdrawn recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01782976 WITHDRAWN
Glioblastoma
M.D. Anderson Cancer Center
2013-06 PHASE2
NCT01118676 COMPLETED
Locally Advanced Non Small Cell Lung Cancer (NSCLC)
Institut Claudius Regaud
2010-03 PHASE1
NCT01276496 COMPLETED
Adult Solid Neoplasm; Estrogen Receptor Negative; HER2/Neu Negative; Male Breast Carcinoma; Progesterone Receptor Negative; Recurrent Breast Carcinoma; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer; Triple-Negative Breast Carcinoma
National Cancer Institute (NCI)
2010-12 PHASE1
NCT01517776 TERMINATED
Gliomas
Martin-Luther-Universität Halle-Wittenberg
2012-01 PHASE2
NCT01165333 COMPLETED
Diffuse Intrinsic Pontine Glioma
Centre Oscar Lambret
2010-09-06 PHASE1
NCT00842712 COMPLETED
Carcinoma, Non-Small-Cell Lung
Merck KGaA, Darmstadt, Germany
2009-02 PHASE2
NCT01558687 TERMINATED
Supratentorial Newly Diagnosed Inoperable Gliobastoma
Merck KGaA, Darmstadt, Germany
2012-08 PHASE1
NCT00813943 COMPLETED
Glioblastoma
EMD Serono
2009-03 PHASE2
NCT00085254 COMPLETED
Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma
National Cancer Institute (NCI)
2005-04 PHASE1; PHASE2
NCT01124240 UNKNOWN
Newly Diagnosed Non Methylated Glioblastoma Multiforme Grade 4
Northern Sydney and Central Coast Area Health Service
2009-11 PHASE2
NCT00689221 COMPLETED
Glioblastoma
EMD Serono
2008-09 PHASE3
NCT00884598 COMPLETED
Brain and Central Nervous System Tumors; Lung Cancer
Universitätsmedizin Mannheim
2008-12 PHASE1
NCT01122888 TERMINATED
Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Adult Solid Neoplasm; Recurrent Adult Brain Neoplasm
National Cancer Institute (NCI)
2009-12 PHASE1
NCT00979862 COMPLETED
Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Recurrent Adult Brain Neoplasm
National Cancer Institute (NCI)
2010-03 PHASE1
NCT01504165 COMPLETED
Renal Impairment
Merck KGaA, Darmstadt, Germany
2012-01 PHASE1
NCT01044225 TERMINATED
Glioblastoma
Bart Neyns
2009-09 PHASE2
NCT00705016 COMPLETED
Squamous Cell Cancer
Merck KGaA, Darmstadt, Germany
2008-10 PHASE1; PHASE2
NCT00121238 COMPLETED
Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer
National Cancer Institute (NCI)
2005-01 PHASE2
NCT00679354 COMPLETED
Childhood High-grade Cerebellar Astrocytoma; Childhood High-grade Cerebral Astrocytoma; Recurrent Childhood Anaplastic Astrocytoma; Recurrent Childhood Anaplastic Oligoastrocytoma; Recurrent Childhood Anaplastic Oligodendroglioma; Recurrent Childhood Brain Tumor; Recurrent Childhood Cerebellar Astrocytoma; Recurrent Childhood Cerebral Astrocytoma; Recurrent Childhood Glioblastoma; Recurrent Childhood Visual Pathway and Hypothalamic Glioma
National Cancer Institute (NCI)
2008-06 PHASE2
NCT00077155 COMPLETED
AIDS-related Peripheral/Systemic Lymphoma; AIDS-related Primary CNS Lymphoma; Anaplastic Large Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Intraocular Lymphoma; Nodal Marginal Zone B-cell Lymphoma; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Hodgkin Lymphoma; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Adult T-cell Leukemia/Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Recurrent Small Lymphocytic Lymphoma; Splenic Marginal Zone Lymphoma; Stage III Adult Burkitt Lymphoma; Stage III Adult Diffuse Large Cell Lymphoma; Stage III Adult Diffuse Mixed Cell Lymphoma; Stage III Adult Diffuse Small Cleaved Cell Lymphoma; Stage III Adult Hodgkin Lymphoma; Stage III Adult Immunoblastic Large Cell Lymphoma; Stage III Adult Lymphoblastic Lymphoma; Stage III Cutaneous T-cell Non-Hodgkin Lymphoma; Stage III Grade 1 Follicular Lymphoma; Stage III Grade 2 Follicular Lymphoma; Stage III Grade 3 Follicular Lymphoma; Stage III Mantle Cell Lymphoma; Stage III Marginal Zone Lymphoma; Stage III Mycosis Fungoides/Sezary Syndrome; Stage III Small Lymphocytic Lymphoma; Stage IV Adult Burkitt Lymphoma; Stage IV Adult Diffuse Large Cell Lymphoma; Stage IV Adult Diffuse Mixed Cell Lymphoma; Stage IV Adult Diffuse Small Cleaved Cell Lymphoma; Stage IV Adult Hodgkin Lymphoma; Stage IV Adult Immunoblastic Large Cell Lymphoma; Stage IV Adult Lymphoblastic Lymphoma; Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma; Stage IV Grade 1 Follicular Lymphoma; Stage IV Grade 2 Follicular Lymphoma; Stage IV Grade 3 Follicular Lymphoma; Stage IV Mantle Cell Lymphoma; Stage IV Marginal Zone Lymphoma; Stage IV Mycosis Fungoides/Sezary Syndrome; Stage IV Small Lymphocytic Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific
National Cancer Institute (NCI)
2003-12 PHASE1
NCT00112866 TERMINATED
Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Recurrent Adult Brain Tumor
National Cancer Institute (NCI)
2005-01 PHASE2
NCT00063973 COMPLETED
Childhood Central Nervous System Germ Cell Tumor; Childhood Choroid Plexus Tumor; Childhood Craniopharyngioma; Childhood Ependymoblastoma; Childhood Grade I Meningioma; Childhood Grade II Meningioma; Childhood Grade III Meningioma; Childhood High-grade Cerebellar Astrocytoma; Childhood High-grade Cerebral Astrocytoma; Childhood Infratentorial Ependymoma; Childhood Low-grade Cerebellar Astrocytoma; Childhood Low-grade Cerebral Astrocytoma; Childhood Medulloepithelioma; Childhood Mixed Glioma; Childhood Oligodendroglioma; Childhood Supratentorial Ependymoma; Recurrent Childhood Brain Stem Glioma; Recurrent Childhood Brain Tumor; Recurrent Childhood Cerebellar Astrocytoma; Recurrent Childhood Cerebral Astrocytoma; Recurrent Childhood Ependymoma; Recurrent Childhood Medulloblastoma; Recurrent Childhood Pineoblastoma; Recurrent Childhood Subependymal Giant Cell Astrocytoma; Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor; Recurrent Childhood Visual Pathway and Hypothalamic Glioma
National Cancer Institute (NCI)
2003-07 PHASE1
NCT00103337 COMPLETED
Recurrent Prostate Cancer; Stage IV Prostate Cancer
National Cancer Institute (NCI)
2005-01 PHASE2
NCT00082875 TERMINATED
Stage III Melanoma; Stage IV Melanoma
National Cancer Institute (NCI)
2004-03 PHASE2
NCT00089388 TERMINATED
Adult Acute Basophilic Leukemia; Adult Acute Eosinophilic Leukemia; Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b)
National Cancer Institute (NCI)
2004-07 PHASE2
NCT00093964 COMPLETED
Glioblastoma Multiforme
EMD Serono
2004-10-13 PHASE2
NCT00022113 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
National Cancer Institute (NCI)
2001-05 PHASE1
NCT00004258 COMPLETED
Chronic Myeloproliferative Disorders; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Precancerous/Nonmalignant Condition; Small Intestine Cancer; Unspecified Adult Solid Tumor, Protocol Specific
Indiana University
1999-12 PHASE1
NCT00006222 TERMINATED
Sarcoma
National Cancer Institute (NCI)
2000-09 PHASE1
NCT00006093 COMPLETED
Brain and Central Nervous System Tumors
New Approaches to Brain Tumor Therapy Consortium
2000-09 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2018-01-19)

Check the Cilengitide (EMD 121974) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cilengitide selectively binds to and inhibits integrins αvβ3 and αvβ5 with IC50 values of 4 nM and 79 nM, respectively, disrupting cell-extracellular matrix interactions and downstream integrin-mediated signaling pathways essential for endothelial cell survival. This targeted blockade impairs tumor angiogenesis and endothelial cell proliferation, suppressing disease growth in clinical trial conditions such as glioblastoma, prostate cancer, and non-small-cell lung carcinoma.

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>).

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