Drugs / Vandetanib
last change Dec 2025 re-read 9 days ago

Vandetanib

Small molecule targets EGFR, KDR, PTK6, RET, SRC, TEK via inhibition

Developed for
non-small cell lung carcinoma · colorectal cancer · lung cancer · breast cancer · medullary thyroid gland carcinoma · prostate cancer · gliosarcoma · head and neck cancer
+67 more · metastatic malignant neoplasm · thyroid cancer · urinary bladder cancer · cancer · esophageal cancer · female breast carcinoma · gastric cancer · gastroesophageal junction adenocarcinoma · hepatocellular carcinoma · malignant glioma · malignant pancreatic neoplasm · ovarian carcinoma · adenocarcinoma · biliary tract cancer · breast neoplasm · cancer of unknown primary site · carcinoma of the ampulla of vater · central nervous system neoplasm · childhood acute myeloid leukemia · clear cell renal carcinoma · colorectal adenocarcinoma · differentiated thyroid carcinoma · diffuse intrinsic pontine glioma · digestive system cancer · fallopian tube cancer · fallopian tube neoplasm · gallbladder cancer · gastrointestinal stromal tumor · glioblastoma · high grade astrocytic tumor · high grade malignant neoplasm · hormone-resistant prostate carcinoma · invasive breast carcinoma · kidney cancer · leiomyomatosis · low grade glioma · lymphoma · lymphoproliferative syndrome · malignant mesothelioma · metastatic neoplasm · metastatic prostate carcinoma · neoplasm · neuroblastoma · ovarian neoplasm · paraganglioma · peritoneal neoplasm · pheochromocytoma · plasma cell myeloma · precancerous condition · primary peritoneal carcinoma · renal cell carcinoma · renal pelvis/ureter urothelial carcinoma · small cell lung carcinoma · small intestine cancer · thyroid gland carcinoma · thyroid tumor · transitional cell carcinoma · ureter cancer · urethra cancer · urothelial carcinoma · von Hippel-Lindau disease · anaplastic astrocytoma · anaplastic oligoastrocytoma · anaplastic oligodendroglioma · head and neck squamous cell carcinoma · lip and oral cavity squamous cell carcinoma · pancreatic ductal adenocarcinoma
Investigated by
Genzyme, a Sanofi Company · AstraZeneca · National Cancer Institute (NCI) · Sanofi · M.D. Anderson Cancer Center · Dana-Farber Cancer Institute
+52 more · Massachusetts General Hospital · Beth Israel Deaconess Medical Center · Brigham and Women's Hospital · Cancer Research UK · Annick Desjardins · Fondation ARC · SWOG Cancer Research Network · Samsung Medical Center · St. Jude Children's Research Hospital · UNICANCER · United States Department of Defense · University of Colorado, Denver · Amsterdam UMC, location VUmc · Barbara Ann Karmanos Cancer Institute · Biocompatibles UK Ltd · Boston Scientific Corporation · Branimir Sikic · British Columbia Cancer Agency · Cardiff University · Case Comprehensive Cancer Center · Celgene Corporation · Fox Chase Cancer Center · French Cooperative Thoracic Intergroup · H. Lee Moffitt Cancer Center and Research Institute · Henry Ford Hospital · Hoosier Cancer Research Network · Leonard Appleman · Mayo Clinic · Memorial Sloan Kettering Cancer Center · Ministry of Health, Republic of Korea · National Institutes of Health Clinical Center (CC) · Novartis Pharmaceuticals · Ontario Clinical Oncology Group (OCOG) · Oslo University Hospital · Patrick Y. Wen, MD · Radiation Therapy Oncology Group · Ronald Weigel · Roswell Park Cancer Institute · Stanford University · Sun Yat-sen University · The Cure Starts Now Foundation · The Research Council of Norway · Tyler's Treehouse · University College, London · University of Chicago · University of Liverpool · University of Pittsburgh · University of Southern California · University of Virginia · University of Wisconsin, Madison · Velindre NHS Trust · West China Hospital

Regulatory milestones approvals, filings & regulatory actions · 6 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed medullary thyroid gland carcinoma 2 milestones
Filed EU (EMA) — medullary thyroid gland carcinoma 2010-09-23

“AstraZeneca today announced that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted regulatory submissions for review of the...” astrazeneca.com ↗

Filed US (FDA) — medullary thyroid gland carcinoma 2010-09-23

“AstraZeneca today announced that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted regulatory submissions for review of the...” astrazeneca.com ↗

Approved Indication not stated 3 milestones
Label expansions (2) US (FDA) CAPRELSA — 2018-10-12 – 2024-03-07 fda.gov ↗
Approved EU (EMA) Caprelsa — 2012-02-16 europa.eu ↗
Approved US (FDA) CAPRELSA — 2011-04-06 fda.gov ↗

Trials 102 · started per year

today
US approved 2011
EU approved 2012
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20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT03291379 May 2017 → Aug 2019 colorectal cancer, hepatocellular carcinoma Boston Scientific Corporation Completed No outcome recorded
Phase 136 trials
Phase 1 NCT01941849 Oct 2014 → Dec 2015 paraganglioma, pheochromocytoma University College, London Withdrawn No outcome recorded Stop: Enrollment
Phase 1 NCT01582191 May 2012 → Oct 2025 metastatic malignant neoplasm M.D. Anderson Cancer Center Completed No outcome recorded
Phase 1 NCT01544140 Apr → Jul 2012 — Sanofi Completed No outcome recorded
Phase 1 NCT01561781 Mar → Jul 2012 — Sanofi Completed No outcome recorded
Phase 1 NCT01551615 Mar → Jun 2012 — Sanofi Completed No outcome recorded
Phase 1 NCT01539655 Feb → Sep 2012 medullary thyroid gland carcinoma Sanofi Completed No outcome recorded
Phase 1 NCT01586624 Jan 2012 → Jun 2020 non-small cell lung carcinoma Cancer Research UK Completed No outcome recorded
Phase 1 NCT01004419 Nov 2009 → Nov 2010 non-small cell lung carcinoma University of Wisconsin, Madison Withdrawn No outcome recorded
Phase 1 NCT00996723 Oct 2009 → Apr 2012 diffuse intrinsic pontine glioma St. Jude Children's Research Hospital Completed No outcome recorded
Phase 1 NCT00807170 May 2009 → Aug 2010 non-small cell lung carcinoma Sanofi Terminated No outcome recorded Stop: Enrollment
Phase 1/26 trials
Phase 1/2 NCT02495103 Aug 2015 → Feb 2020 leiomyomatosis, renal cell carcinoma National Cancer Institute (NCI) Terminated No outcome recorded
Phase 1/2 NCT01661179 Nov 2012 → Dec 2013 medullary thyroid gland carcinoma Genzyme, a Sanofi Company Completed No outcome recorded
Phase 1/2 NCT00862836 Apr 2009 → Sep 2010 ovarian carcinoma Genzyme, a Sanofi Company Terminated No outcome recorded
Phase 1/2 NCT00923247 Feb 2009 → Apr 2016 medullary thyroid gland carcinoma National Cancer Institute (NCI) Terminated No outcome recorded Stop: Enrollment
Phase 1/2 NCT00514046 Jul 2007 → Dec 2019 medullary thyroid gland carcinoma, multiple endocrine neoplasia type 2A, multiple endocrine neoplasia type 2B National Cancer Institute (NCI) Completed No outcome recorded
Phase 1/2 NCT00441142 May 2007 → Aug 2013 gliosarcoma Patrick Y. Wen, MD Completed No outcome recorded
Phase 251 trials · 4 met primary · 8 missed
Phase 2 NCT06482086 Jun 2021 → Dec 2024 overdue thyroid gland carcinoma West China Hospital Recruiting Met primary
Phase 2 NCT03630120 Aug 2018 → Nov 2019 medullary thyroid gland carcinoma, poorly differentiated thyroid gland carcinoma, thyroid gland papillary carcinoma H. Lee Moffitt Cancer Center and Research Institute Terminated No outcome recorded
Phase 2 NCT02788201 Mar 2017 → Oct 2019 urinary bladder cancer, urothelial carcinoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT02638428 Dec 2015 → Dec 2021 childhood acute myeloid leukemia Samsung Medical Center Unknown No outcome recorded
Phase 2 NCT02530411 Apr 2015 → Dec 2018 neoplasm Velindre NHS Trust Unknown Missed primary
Phase 2 NCT01823068 Nov → Dec 2014 non-small cell lung carcinoma Samsung Medical Center Completed No outcome recorded
Phase 2 NCT02142036 May 2014 → Aug 2018 metastatic malignant neoplasm Oslo University Hospital Completed Met primary
Phase 2 NCT02117167 Apr 2014 → Dec 2018 non-small cell lung carcinoma UNICANCER Completed No outcome recorded
Phase 2 NCT02299999 Apr 2014 → Dec 2022 overdue breast cancer UNICANCER Active not recruiting No outcome recorded
Phase 2 NCT02015065 Dec 2013 → May 2016 gastrointestinal stromal tumor National Cancer Institute (NCI) Completed No outcome recorded
Phase 36 trials · 3 met primary · 2 missed
Phase 3 NCT01876784 Sep 2013 → Aug 2015 differentiated thyroid carcinoma Genzyme, a Sanofi Company Completed Missed primary
Phase 3 NCT00418886 Jan 2007 → Sep 2008 non-small cell lung carcinoma Genzyme, a Sanofi Company Completed Missed primary
Phase 3 NCT00410761 Nov 2006 → Jul 2009 thyroid cancer Genzyme, a Sanofi Company Completed Met primary
Phase 3 NCT00404924 Nov 2006 → Oct 2009 non-small cell lung carcinoma Genzyme, a Sanofi Company Completed No outcome recorded
Phase 3 NCT00364351 Aug 2006 → Sep 2008 non-small cell lung carcinoma Genzyme, a Sanofi Company Completed Met primary
Phase 3 NCT00312377 May 2006 → Aug 2008 non-small cell lung carcinoma Genzyme, a Sanofi Company Completed Met primary
Phase not applicable2 trials
— NCT02239952 Nov 2014 → Nov 2021 malignant glioma Amsterdam UMC, location VUmc Unknown No outcome recorded
— NCT02013089 Dec 2013 → May 2017 digestive system cancer Sun Yat-sen University Unknown No outcome recorded
Comparator or background therapy8 trials
Phase 1 NCT00681798 Comparator Jul 2006 → Jun 2009 pancreatic ductal adenocarcinoma Sanofi Completed No outcome recorded
Phase 2 NCT00995007 Comparator Sep 2009 → Jun 2015 anaplastic astrocytoma, anaplastic oligoastrocytoma, anaplastic oligodendroglioma, gliosarcoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT00687297 Comparator Apr 2008 → Jan 2011 non-small cell lung carcinoma PrECOG, LLC. Completed No outcome recorded
Phase 2 NCT00459043 Comparator Mar 2007 → Mar 2010 head and neck squamous cell carcinoma Dana-Farber Cancer Institute Completed No outcome recorded
Phase 3 NCT04760288 Comparator Nov 2023 → Oct 2027 medullary thyroid gland carcinoma Hoffmann-La Roche Withdrawn No outcome recorded

News releases announcing trial results or a regulatory action · 7

DateIssuerRelease
2012-02-21 AstraZeneca Regulatory European Commission approves CAPRELSA® (vandetanib) for patients with advanced medullary thyroid cancer astrazeneca.com ↗
AstraZeneca today announced that the European Commission has granted marketing authorisation for CAPRELSA® (vandetanib) for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.
2011-11-18 AstraZeneca Regulatory CAPRELSA™ (vandetanib) receives positive CHMP opinion in the European Union for treating advanced medullary thyroid cancer astrazeneca.com ↗
AstraZeneca today announced that the Marketing Authorisation Application for CAPRELSA (vandetanib) received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.
2011-04-07 AstraZeneca Regulatory FDA approves orphan drug vandetanib astrazeneca.com ↗
AstraZeneca today announced that the US Food and Drug Administration (FDA) approved the orphan drug vandetanib
2011-01-07 AstraZeneca Regulatory US Food and Drug Administration extend review timeline for vandetanib new drug application astrazeneca.com ↗
AstraZeneca announced today that the US Food and Drug Administration (FDA) has extended the time to complete its review of the New Drug Application (NDA) for the investigational drug vandetanib.
2010-12-02 AstraZeneca Regulatory US FDA Advisory Committee Makes Recommendation on New Drug Application for Vandetanib in Advanced Medullary Thyroid Cancer astrazeneca.com ↗
The Committee acknowledged that there are patients with MTC in which the risk-benefit profile of vandetanib was acceptable, and voted 10 to 0 in favour of a post-approval study requirement to evaluate other doses.
2010-09-23 AstraZeneca Regulatory US and EU regulatory submissions for VANDETANIB in advanced medullary thyroid cancer accepted for review astrazeneca.com ↗
AstraZeneca today announced that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted regulatory submissions for review of the investigational drug vandetanib in the treatment of patients with advanced medullary thyroid cancer (MTC).
2009-10-28 AstraZeneca Regulatory AstraZeneca withdraws regulatory submissions for Zactima (vandetanib) in combination with chemotherapy for advanced NSCLC astrazeneca.com ↗
AstraZeneca announced today that it has withdrawn the regulatory submissions for the use of ZACTIMA (vandetanib) 100mg in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) from the US FDA and the European Medicines Agency (EMEA).

Evidence & citations 20 cited values

Every value below carries the sentence it was read from. 114 sources stand behind the page.

FieldValueCited text
Known as vandetanib “Phase I study of cetuximab, irinotecan, and vandetanib (ZD6474) as therapy for patients with previously treated metastastic colorectal cancer.” PMID 22701615 ↗ Jun 2012
89

“BTG-002814 (containing 100 mg vandetanib) delivered transarterially, 7 to 21 days before surgery” PMID 31579027 ↗ Oct 2019

“Tretinoin, Vandetanib, Vemurafenib” NCT02788201 ↗

“ZD6474 (vandetanib) 100mg” NCT00507091 ↗

“ZD6474 (vandetanib) 100mg” NCT00496509 ↗

“Drug: ZD6474 (vandetanib)” NCT00450138 ↗

“ZD6474 (vandetanib) 100mg” NCT00252746 ↗

“ZD6474(Vandetanib) 300 mg” NCT00508001 ↗

“ZD6474 (vandetanib)” NCT00098345 ↗

“ZD6474 (vandetanib)” NCT00499850 ↗

“ZD6474 (vandetanib)” NCT00358956 ↗

Show 79 more sources

Known as AZD6474 “A Phase I Trial of Vandetanib (AZD6474) and Selumetinib (AZD6244) for Solid Tumours Including Non Small Cell Lung Cancer (VanSel-1)” NCT01586624 ↗
Known as CAPRELSA “A Phase I, Randomized, Open-label, Single-center Study to Assess the Pharmacokinetics of Vandetanib (CAPRELSA) in Healthy Subjects when a Single Oral Dose of Vandetanib 300 mg...” NCT01539655 ↗
4

“A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of Midazolam, a CYP3A4 Substrate, in Healthy Subjects When Administered Alone and in Combination with...” NCT01544140 ↗

“with a Single Dose of Vandetanib (CAPRELSA) 300 mg” NCT01561781 ↗

“Vandetanib (CAPRELSA) 800 mg” NCT01551615 ↗

“Caprelsa (vandetanib)” NCT01601808 ↗

Known as Caprelsa(R) “Phase II Trial of Vandetanib (ZD6474, Caprelsa(R) in Children and Adults With Wild-Type Gastrointestinal Stromal Tumors” NCT02015065 ↗
Known as GNF-PF-2188 ChEMBL registry synonym — accepted as the source's own label CHEMBL24828 ↗
Known as NSC-744325 ChEMBL registry synonym — accepted as the source's own label CHEMBL24828 ↗
Known as NSC-760766 ChEMBL registry synonym — accepted as the source's own label CHEMBL24828 ↗
Known as SAR390530 “Vandetanib (SAR390530)” NCT01876784 ↗
Known as Vandetanib - Zactima (ZD 6474) “Vandetanib - Zactima (ZD 6474)” NCT00613223 ↗
Known as Zactima “Vandetanib (ZACTIMA; ZD6474; AstraZeneca) is an oral small molecule antineoplastic drug that inhibits vascular endothelial growth factor receptor 2 (VEGFR2), estimated...” NCT02015065 ↗
9

“A Targeted Phase I/II Trial of ZD6474 (Vandetanib; ZACTIMA) Plus the Proteasome Inhibitor, Bortezomib (Velcade ), in Adults With Solid Tumors With a Focus on Hereditary or...” NCT00923247 ↗

“This study will examine the effectiveness of an investigational drug called ZD6474 (also known as vandetanib or ZACTIMA).” NCT00566995 ↗

“This study uses the drugs Abraxane (also called ABI-007) and Vandetanib (also called Zactima and ZD6474).” NCT00667147 ↗

“ZD6474 (Zactima) 100mg” NCT00496509 ↗

“Zactima (vandetanib)” NCT00498797 ↗

“Zactima (ZD6474)” NCT00496275 ↗

NCT00811369 ↗

NCT00613054 ↗

NCT00459121 ↗

Known as ZD-64 ChEMBL registry synonym — accepted as the source's own label CHEMBL24828 ↗
Known as ZD6474 “A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Phase III Study to Assess the Efficacy and Safety of Vandetanib (CAPRELSA™; SAR390530 (Formerly AstraZeneca...” NCT01876784 ↗
42

“Vandetanib (CAPRELSA; ZD6474) potently inhibits vascular endothelial growth factor receptor-2 (VEGFR-2), and shows additional inhibitory activity at sub-micromolar...” NCT00923247 ↗

“Randomized Phase II Study of Docetaxel Followed by Vandetanib (ZD6474) vs. Docetaxel Plus Vandetanib in Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian...” NCT00872989 ↗

“This was a parallel group, randomized, double blind, placebo controlled, multicentre study designed to assess whether vandetanib (ZD6474) conferred an improvement in PFS as...” NCT00537095 ↗

“Vandetanib (ZD 6474) and Bevacizumab Combination Therapy Evaluating the VEGF and EGF Signal Transduction Pathways in Adults With Solid Tumors and Lymphomas” NCT00734890 ↗

“In vivo experiments have documented the ability of vandetanib (ZD6474) to inhibit tumor growth in various preclinical tumor models.” NCT00995007 ↗

“This study will examine the effectiveness of an investigational drug called ZD6474 (also known as vandetanib or ZACTIMA).” NCT00566995 ↗

“Phase II Trial of Vandetanib (ZD6474, Caprelsa(R) in Children and Adults With Wild-Type Gastrointestinal Stromal Tumors” NCT02015065 ↗

“This study uses the drugs Abraxane (also called ABI-007) and Vandetanib (also called Zactima and ZD6474).” NCT00667147 ↗

“ZD6474 (Vandetanib at the dose of 100 mg)” NCT00752986 ↗

“ZD6474 (vandetanib) 100mg” NCT00506051 ↗

Show 32 more sources

Action Inhibit “vandetanib, an inhibitor of vascular endothelial and epidermal growth factor receptors” PMID 17878480 ↗ Sep 2007
3

“Tyrosine-protein kinase TIE-2 inhibitor” CHEMBL24828 ↗

“Tyrosine-protein kinase BRK inhibitor” CHEMBL24828 ↗

“Tyrosine-protein kinase SRC inhibitor” CHEMBL24828 ↗

Modality Small molecule “Vandetanib is a novel oral molecule (anilinoquinazoline)” NCT00687297 ↗
Route Oral “300-mg Daily Oral Dose” NCT00034918 ↗
Target EGFR “vandetanib, a selective inhibitor of VEGFR, RET and EGFR signaling” PMID 25881079 ↗ Mar 2015
Target PTK6 “Tyrosine-protein kinase BRK inhibitor” CHEMBL24828 ↗
Target RET “vandetanib, a selective inhibitor of VEGFR, RET and EGFR signaling” PMID 25881079 ↗ Mar 2015
Target SRC “Tyrosine-protein kinase SRC inhibitor” CHEMBL24828 ↗
Target TEK “Tyrosine-protein kinase TIE-2 inhibitor” CHEMBL24828 ↗