NCT00828919 is a NA clinical trial of axitinib in Solid Tumors, sponsored by Pfizer.

Who is sponsoring NCT00828919?

NCT00828919 is sponsored by Pfizer.

What drugs are being tested in NCT00828919?

Interventions in NCT00828919: axitinib, crizotinib.

What condition does NCT00828919 study?

NCT00828919 studies Solid Tumors.

Is NCT00828919 still recruiting?

NCT00828919 is currently completed. Last updated 3 December 2024.

Are results published for NCT00828919?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-12-03 · How we verify

NCT00828919

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Continuing Access to Axitinib (A406- AG- 013736 ) For Patients Previously Receiving AG 013736 In Clinical Trials

Completed NA Results posted Last updated 3 December 2024

What this trial tests

NA trial testing axitinib in Solid Tumors in 52 participants. Completed in 14 August 2023.

Timeline

7 March 2003

Primary endpoint
14 August 2023

14 August 2023

Quick facts

Lead sponsor	Pfizer
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Masking	none
Primary purpose	treatment
Enrollment	52
Start date	7 March 2003
Primary completion	14 August 2023
Estimated completion	14 August 2023
Sites	34 locations across France, Italy, Japan, Russia, Taiwan, United Kingdom, Germany, Hungary

Drugs / interventions tested

axitinib — full drug profile →
crizotinib (crizotinib) — full drug profile →

Conditions studied

Solid Tumors — all drugs for Solid Tumors →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs Primary · Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow-up to approximately 120.56 months)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

TEAEs

Group	Value	95% CI
Overall	49
Axitinib 2 mg	7
Axitinib 3 mg	9
Axitinib 5 mg	20
Axitinib 7 mg	2
Other	11

Serious TEAEs

Group	Value	95% CI
Overall	21
Axitinib 2 mg	4
Axitinib 3 mg	8
Axitinib 5 mg	5
Axitinib 7 mg	0
Other	4

Treatment Related TEAEs

Group	Value	95% CI
Overall	47
Axitinib 2 mg	7
Axitinib 3 mg	9
Axitinib 5 mg	18
Axitinib 7 mg	2
Other	11

Treatment Related Serious TEAEs

Group	Value	95% CI
Overall	15
Axitinib 2 mg	2
Axitinib 3 mg	7
Axitinib 5 mg	3
Axitinib 7 mg	0
Other	3

Adverse events — posted to ClinicalTrials.gov

Time frame: Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Overall

Serious: 21/49 (43%)

Deaths: 5/49

Axitinib 2 mg

Serious: 4/7 (57%)

Deaths: 1/7

Axitinib 3 mg

Serious: 8/9 (89%)

Deaths: 1/9

Axitinib 5 mg

Serious: 5/20 (25%)

Deaths: 3/20

Axitinib 7 mg

Serious: 0/2 (0%)

Deaths: 0/2

Other

Serious: 4/11 (36%)

Deaths: 0/11

Serious adverse events (41 terms)

Reaction	System	Overall	Axitinib 2 mg	Axitinib 3 mg	Axitinib 5 mg	Axitinib 7 mg	Other
Myocardial infarction	Cardiac disorders	—	—	—	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—
Acute coronary syndrome	Cardiac disorders	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—
Hyperkalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—
Arrhythmia	Cardiac disorders	—	—	—	—	—	—
Cardio-respiratory arrest	Cardiac disorders	—	—	—	—	—	—
Intracardiac thrombus	Cardiac disorders	—	—	—	—	—	—
Retinal vein occlusion	Eye disorders	—	—	—	—	—	—
Ascites	Gastrointestinal disorders	—	—	—	—	—	—
Colitis	Gastrointestinal disorders	—	—	—	—	—	—
Enterocolitis	Gastrointestinal disorders	—	—	—	—	—	—
Gastric ulcer haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Pancreatitis	Gastrointestinal disorders	—	—	—	—	—	—
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—
Chest pain	General disorders	—	—	—	—	—	—
Disease progression	General disorders	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—
Biliary obstruction	Hepatobiliary disorders	—	—	—	—	—	—
Septic shock	Infections and infestations	—	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—	—

Other adverse events (211 terms — click to expand)

Reaction	System	Overall	Axitinib 2 mg	Axitinib 3 mg	Axitinib 5 mg	Axitinib 7 mg	Other
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—	—
Hypothyroidism	Endocrine disorders	—	—	—	—	—	—
Proteinuria	Renal and urinary disorders	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Dysphonia	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—
Chest pain	General disorders	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—
Oedema	General disorders	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—
Hyperuricaemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—	—	—

Most-reported serious reactions: Myocardial infarction, Acute myocardial infarction, Dehydration, Acute coronary syndrome, Diarrhoea, Vomiting, Hyperkalaemia, Neutropenia.

Data from ClinicalTrials.gov NCT00828919 adverse events section.

Sponsor's own description

To allow continuation of axitinib (AG 013736) treatment to patients experiencing clinical benefit in a closing axitinib trial

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

A Phase II trial of axitinib in patients with various histologic subtypes of advanced thyroid cancer: long-term outcomes and pharmacokinetic/pharmacodynamic analyses.
Cohen EE, Tortorici M, Kim S, Ingrosso A, et al · · 2014 · cited 38× · PMID 25315258 · DOI 10.1007/s00280-014-2604-8
Phase I Study of Axitinib in Combination with Cisplatin and Capecitabine in Patients with Previously Untreated Advanced Gastric Cancer.
Oh DY, Doi T, Shirao K, Lee KW, et al · · 2015 · cited 11× · PMID 25687867 · DOI 10.4143/crt.2014.225
Clinical Utility of Cabozantinib in the Treatment of Locally Advanced or Metastatic Differentiated Thyroid Carcinoma: Patient Selection and Reported Outcomes.
Roof L, Geiger JL. · · 2023 · cited 5× · PMID 37070083 · DOI 10.2147/cmar.s348711

Verify or expand the search:

Other trials of axitinib

Trials testing the same drug.

NCT05949632 — A Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors · Phase 1, PHASE2 · terminated
NCT05256472 — A Study of AK104 Monotherapy or AK104 Plus Axitinib in Advanced/Metastatic Renal Cell Carcinoma · Phase 2 · active not recruiting
NCT05650164 — Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Stu · completed
NCT05097599 — StrataPATH™ (Precision Indications for Approved Therapies) · Phase 2 · terminated
NCT05012865 — Current Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospec · completed

Other recruiting trials for Solid Tumors

Currently open trials in the same condition.

NCT07529002 — Clinical Application of 89Zr-s-C1 PET/CT Imaging in Solid Tumors · recruiting
NCT07416123 — A Study of GEN1106 in Participants With Solid Tumors · Phase 1 · recruiting
NCT07522073 — A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancre · Phase 3 · recruiting
NCT07395258 — A Study to Test Different Doses of BI 3923948 Alone and in Combination With an Anti-PD-1 Antibody in People With Differe · Phase 1 · recruiting
NCT07505069 — Exploring the Clinical Value of RT01-89Zr PET Imaging in Solid Tumors · EARLY_PHASE1 · recruiting

Other Pfizer trials

Trials by the same sponsor.

NCT04982848 — Korea Post Marketing Surveillance (PMS) Study of Talzenna® · not yet recruiting
NCT06873191 — A Study to Learn More About Tukysa Once it is Out in the Korean Market · not yet recruiting
NCT07497854 — A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea · not yet recruiting
NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta · Phase 1 · not yet recruiting
NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00828919 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 3 December 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00828919.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing