Clinical Trials

A clinical trial sponsored by the National Cancer Institute evaluated Cediranib Maleate in a completed early-phase study assessing safety, pharmacokinetics, and biological effects in patients with advanced hematologic malignancies and unspecified solid tumors. The broad range of conditions evaluated included Hodgkin and non-Hodgkin lymphomas, follicular lymphoma, mantle cell lymphoma, hairy cell leukemia, and adult or pediatric solid tumors. This clinical trial provides foundational data regarding the tolerability and early therapeutic potential of VEGFR inhibition across complex oncological indications.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00458731 Completed
Adult Grade III Lymphomatoid Granulomatosis|Adult Nasal Type Extranodal NK/T-cell Lymphoma|Anaplastic Large Cell Lymphoma|Angioimmunoblastic T-cell Lymphoma|Childhood Burkitt Lymphoma|Childhood Diffuse Large Cell Lymphoma|Childhood Grade III Lymphomatoid Granulomatosis|Childhood Immunoblastic Large Cell Lymphoma|Childhood Nasal Type Extranodal NK/T-cell Lymphoma|Cutaneous B-cell Non-Hodgkin Lymphoma|Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue|Hepatosplenic T-cell Lymphoma|Intraocular Lymphoma|Nodal Marginal Zone B-cell Lymphoma|Noncutaneous Extranodal Lymphoma|Peripheral T-cell Lymphoma|Progressive Hairy Cell Leukemia Initial Treatment|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 Childhood Anaplastic Large Cell Lymphoma|Recurrent Childhood Large Cell Lymphoma|Recurrent Childhood Lymphoblastic Lymphoma|Recurrent Childhood Small Noncleaved Cell Lymphoma|Recurrent Grade 1 Follicular Lymphoma|Recurrent Grade 2 Follicular Lymphoma|Recurrent Grade 3 Follicular Lymphoma|Recurrent Mantle Cell Lymphoma|Recurrent Mycosis Fungoides/Sezary Syndrome|Recurrent/Refractory Childhood Hodgkin Lymphoma|Refractory Hairy Cell Leukemia|Small Intestine Lymphoma|Splenic Marginal Zone 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 Adult T-cell Leukemia/Lymphoma|Stage IV Childhood Anaplastic Large Cell Lymphoma|Stage IV Childhood Hodgkin Lymphoma|Stage IV Childhood Large Cell Lymphoma|Stage IV Childhood Lymphoblastic Lymphoma|Stage IV Childhood Small Noncleaved Cell 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 IVA Mycosis Fungoides/Sezary Syndrome|Stage IVB Mycosis Fungoides/Sezary Syndrome|T-cell Large Granular Lymphocyte Leukemia|Testicular Lymphoma|Unspecified Adult Solid Tumor Protocol Specific|Unspecified Childhood Solid Tumor Protocol Specific|Waldenström Macroglobulinemia
National Cancer Institute (NCI)
2007-05 Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Cediranib Maleate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cediranib Maleate potently binds to vascular endothelial growth factor receptors (VEGFR) and Flt1/4, effectively blocking receptor autophosphorylation and downstream pro-angiogenic signaling cascades within the vascular endothelium. This targeted inhibition suppresses endothelial cell proliferation, survival, and sprout formation, which ultimately starves solid tumors and hematologic malignancies—such as various lymphomas and leukemias studied in clinical trials—of essential vascular supply and retards tumor progression.

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.