NCT00625378 (STEP) is a Phase 3 clinical trial of Sorafenib (Nexavar, BAY43-9006) in Neoplasms, sponsored by Bayer.

Who is sponsoring NCT00625378?

NCT00625378 is sponsored by Bayer.

What drugs are being tested in NCT00625378?

Interventions in NCT00625378: Sorafenib (Nexavar, BAY43-9006).

Is NCT00625378 still recruiting?

NCT00625378 is currently completed. Last updated 1 September 2022.

Are results published for NCT00625378?

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

Last reviewed 2022-09-01 · How we verify

NCT00625378: STEP

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

Sorafenib Long Term Extension Program

Completed Phase 3 Results posted Last updated 1 September 2022

What this trial tests

Phase 3 trial testing Sorafenib (Nexavar, BAY43-9006) in Neoplasms in 206 participants. Completed in 24 September 2021.

Timeline

21 December 2007

Primary endpoint
24 September 2021

24 September 2021

Quick facts

Lead sponsor	Bayer
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	206
Start date	21 December 2007
Primary completion	24 September 2021
Estimated completion	24 September 2021
Sites	74 locations across Hong Kong, Colombia, Italy, Taiwan, Poland, South Korea, New Zealand, Belgium

Drugs / interventions tested

Sorafenib (Nexavar, BAY43-9006) — full drug profile →

Conditions studied

Neoplasms — all drugs for Neoplasms →

Sponsor

Bayer — full company profile →

Who can join

16 and older, any sex, with Neoplasms. 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.

Sorafenib Treatment Duration Within STEP Primary · From the date of the first sorafenib dose until the date of the last sorafenib dose, with a mean duration of 25 months and max duraton of 153.8 months

Treatment duration was calculated in days as the date of the last dose of any study treatment minus date of the first dose of any study treatment plus one day.

Group	Value	95% CI
Sorafenib Monotherapy	15.69	6.41 – 33.19
Sorafenib+Erlotinib	40.13	40.13 – 40.13

Number of Participants With New Treatment-emergent Adverse Events (TEAEs) Primary · From signing the informed consent form (ICF) in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months

An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product. The adverse event did not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) was any untoward medical occurrence that at any dose: resulted in death; was life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; was a congenital anomaly or birth defect; was an important medical event. A new

Any AE

Group	Value	95% CI
Sorafenib Monotherapy	166
Sorafenib+Erlotinib	1

Serious AE (SAE)

Group	Value	95% CI
Sorafenib Monotherapy	113
Sorafenib+Erlotinib	1

AE leading to dose modification

Group	Value	95% CI
Sorafenib Monotherapy	64
Sorafenib+Erlotinib	0

AE leading to study drug discontinuation

Group	Value	95% CI
Sorafenib Monotherapy	56
Sorafenib+Erlotinib	0

AE leading to death

Group	Value	95% CI
Sorafenib Monotherapy	37
Sorafenib+Erlotinib	0

Sorafenib-related AE

Group	Value	95% CI
Sorafenib Monotherapy	117
Sorafenib+Erlotinib	1

Sorafenib-related SAE

Group	Value	95% CI
Sorafenib Monotherapy	25
Sorafenib+Erlotinib	1

Sorafenib-related AE leading to dose modification

Group	Value	95% CI
Sorafenib Monotherapy	42
Sorafenib+Erlotinib	0

Number of Participants With New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade Primary · From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months

An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product. The AE did not necessarily have to have a causal relationship with this treatment. A new treatment-emergent adverse event (TEAE) was any AE that had a start date on or after ICF date in STEP and up to 30 days after the last sorafenib dose. The intensity or severity of AEs were graded using the National Cancer Institute-Common Terminology Criteria, Version 3.0 (NCI-CTC v. 3.0). The Common Terminology Criteria for AE (CTCAE) are a set of cri

Grade 3

Group	Value	95% CI
Sorafenib Monotherapy	71
Sorafenib+Erlotinib	1

Grade 4

Group	Value	95% CI
Sorafenib Monotherapy	17
Sorafenib+Erlotinib	1

Grade 5

Group	Value	95% CI
Sorafenib Monotherapy	37
Sorafenib+Erlotinib	0

Number of Participants With Study Drug-related New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade Primary · From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months

An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product. The AE did not necessarily have to have a causal relationship with this treatment. A new treatment-emergent AE (TEAE) was any AE that had a start date on or after ICF date in STEP and up to 30 days after the last sorafenib dose. A drug-related new TEAE was a new TEAE that had a causal relationship with the study treatment as assessed by the investigator. The intensity or severity of AEs were graded using the National Cancer Institute-Commo

Grade 3

Group	Value	95% CI
Sorafenib Monotherapy	49
Sorafenib+Erlotinib	1

Grade 4

Group	Value	95% CI
Sorafenib Monotherapy	6
Sorafenib+Erlotinib	0

Grade 5

Group	Value	95% CI
Sorafenib Monotherapy	2
Sorafenib+Erlotinib	0

Number of Participants With All Adverse Events Primary · From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months

An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product. The AE did not necessarily have to have a causal relationship with this treatment. A drug-related AE was any AE that had a causal relationship with the study treatment as assessed by the investigator. All AEs in STEP were the combination of AEs ongoing from feeder studies and new TEAEs.

Any AE

Group	Value	95% CI
Sorafenib Monotherapy	184
Sorafenib+Erlotinib	1

Serious AE (SAE)

Group	Value	95% CI
Sorafenib Monotherapy	114
Sorafenib+Erlotinib	1

AE leading to dose modification

Group	Value	95% CI
Sorafenib Monotherapy	72
Sorafenib+Erlotinib	0

AE leading to study drug discontinuation

Group	Value	95% CI
Sorafenib Monotherapy	56
Sorafenib+Erlotinib	0

AE leading to death

Group	Value	95% CI
Sorafenib Monotherapy	37
Sorafenib+Erlotinib	0

Sorafenib-related AE

Group	Value	95% CI
Sorafenib Monotherapy	159
Sorafenib+Erlotinib	1

Sorafenib-related SAE

Group	Value	95% CI
Sorafenib Monotherapy	26
Sorafenib+Erlotinib	1

Sorafenib-related AE leading to dose modification

Group	Value	95% CI
Sorafenib Monotherapy	53
Sorafenib+Erlotinib	0

Number of Participants With All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE Grade Primary · From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months

An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product. The AE did not necessarily have to have a causal relationship with this treatment. All AEs in STEP were the combination of AEs ongoing from feeder studies and new TEAEs. The intensity or severity of AEs were graded using the National Cancer Institute-Common Terminology Criteria, Version 3.0 (NCI-CTC v. 3.0). The Common Terminology Criteria for AE (CTCAE) are a set of criteria for the standardized classification of adverse effects of drugs

Grade 3

Group	Value	95% CI
Sorafenib Monotherapy	81
Sorafenib+Erlotinib	1

Grade 4

Group	Value	95% CI
Sorafenib Monotherapy	17
Sorafenib+Erlotinib	1

Grade 5

Group	Value	95% CI
Sorafenib Monotherapy	37
Sorafenib+Erlotinib	0

Number of Participants With Study Drug-related All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE Primary · From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months

An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product. The AE did not necessarily have to have a causal relationship with this treatment. A drug-related AE was any AE that had a causal relationship with the study treatment as assessed by the investigator. All AEs in STEP was a combination of AEs ongoing from feeder studies and new TEAEs. The intensity or severity of AEs were graded using the National Cancer Institute-Common Terminology Criteria, Version 3.0 (NCI-CTC v. 3.0). The Common Termino

Grade 3

Group	Value	95% CI
Sorafenib Monotherapy	65
Sorafenib+Erlotinib	1

Grade 4

Group	Value	95% CI
Sorafenib Monotherapy	6
Sorafenib+Erlotinib	0

Grade 5

Group	Value	95% CI
Sorafenib Monotherapy	2
Sorafenib+Erlotinib	0

Number of Deaths With Primary Cause of Death Primary · From signing the ICF in STEP until completion or discontinuation of the study, with a mean duration of 26 months

Primary cause of death included: any cause; progressive disease; toxicity due to study treatment (with at least one AE with outcome death); other (unspecified) or missing cause.

Any cause

Group	Value	95% CI
Sorafenib Monotherapy	62
Sorafenib+Erlotinib	0

Progressive disease

Group	Value	95% CI
Sorafenib Monotherapy	34
Sorafenib+Erlotinib	0

Toxicity due to study treatment

Group	Value	95% CI
Sorafenib Monotherapy	3
Sorafenib+Erlotinib	0

Other

Group	Value	95% CI
Sorafenib Monotherapy	21
Sorafenib+Erlotinib	0

Missing

Group	Value	95% CI
Sorafenib Monotherapy	4
Sorafenib+Erlotinib	0

Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade Primary · From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months

Hematology and blood chemistry values were summarized according to their worst CTCAE grade, where applicable. Hematology and blood chemistry values were graded based on the applicable laboratory threshold values outlined in NCI CTCAE version 3.0. Participants with a specific laboratory value that were "not graded" are not included in the table. CTCAE grade was set to "not graded" if the reference ranges or other information necessary to derive grades were unavailable or result had a special character (such as \> or \< ). The Common Terminology Criteria for Adverse Events (CTCAE) are a set of c

Neutrophils - Grade 1

Group	Value	95% CI
Sorafenib Monotherapy	19

Neutrophils - Grade 2

Group	Value	95% CI
Sorafenib Monotherapy	7

Neutrophils - Grade 3

Group	Value	95% CI
Sorafenib Monotherapy	0

Neutrophils - Grade 4

Group	Value	95% CI
Sorafenib Monotherapy	2

Hemoglobin - Grade 1

Group	Value	95% CI
Sorafenib Monotherapy	67
Sorafenib+Erlotinib	1

Hemoglobin - Grade 2

Group	Value	95% CI
Sorafenib Monotherapy	40
Sorafenib+Erlotinib	0

Hemoglobin - Grade 3

Group	Value	95% CI
Sorafenib Monotherapy	13
Sorafenib+Erlotinib	0

Hemoglobin - Grade 4

Group	Value	95% CI
Sorafenib Monotherapy	8
Sorafenib+Erlotinib	0

Number of Participants With ECOG Performance Status by 6-months Time Intervals Primary · Up to 156 months

Eastern cooperative oncology group (ECOG) performance status: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light house work, office work; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled, cannot carry on any self-care, totally conf

Months 1-6

Group	Value	95% CI
Sorafenib Monotherapy	2
Sorafenib+Erlotinib	0
Sorafenib Monotherapy	28
Sorafenib+Erlotinib	1
Sorafenib Monotherapy	11
Sorafenib+Erlotinib	0
Sorafenib Monotherapy	1
Sorafenib+Erlotinib	0

Months 7-12

Group	Value	95% CI
Sorafenib Monotherapy	3
Sorafenib+Erlotinib	0
Sorafenib Monotherapy	29
Sorafenib+Erlotinib	1
Sorafenib Monotherapy	6
Sorafenib+Erlotinib	0
Sorafenib Monotherapy	0
Sorafenib+Erlotinib	0

Months 13-18

Group	Value	95% CI
Sorafenib Monotherapy	2
Sorafenib+Erlotinib	0
Sorafenib Monotherapy	22
Sorafenib+Erlotinib	1
Sorafenib Monotherapy	7
Sorafenib+Erlotinib	0
Sorafenib Monotherapy	1
Sorafenib+Erlotinib	0

Months 19-24

Group	Value	95% CI
Sorafenib Monotherapy	2
Sorafenib+Erlotinib	0
Sorafenib Monotherapy	15
Sorafenib+Erlotinib	1
Sorafenib Monotherapy	9
Sorafenib+Erlotinib	0
Sorafenib Monotherapy	1
Sorafenib+Erlotinib	0

Months 25-30

Group	Value	95% CI
Sorafenib Monotherapy	2
Sorafenib+Erlotinib	0
Sorafenib Monotherapy	13
Sorafenib+Erlotinib	1
Sorafenib Monotherapy	7
Sorafenib+Erlotinib	0
Sorafenib Monotherapy	0
Sorafenib+Erlotinib	0

Months 31-36

Group	Value	95% CI
Sorafenib Monotherapy	1
Sorafenib+Erlotinib	0
Sorafenib Monotherapy	9
Sorafenib+Erlotinib	1
Sorafenib Monotherapy	8
Sorafenib+Erlotinib	0
Sorafenib Monotherapy	0
Sorafenib+Erlotinib	0

Months 37-42

Group	Value	95% CI
Sorafenib Monotherapy	0
Sorafenib+Erlotinib	0
Sorafenib Monotherapy	10
Sorafenib+Erlotinib	1
Sorafenib Monotherapy	8
Sorafenib+Erlotinib	0
Sorafenib Monotherapy	0
Sorafenib+Erlotinib	0

Months 43-48

Group	Value	95% CI
Sorafenib Monotherapy	0
Sorafenib+Erlotinib	0
Sorafenib Monotherapy	9
Sorafenib+Erlotinib	0
Sorafenib Monotherapy	6
Sorafenib+Erlotinib	0
Sorafenib Monotherapy	0
Sorafenib+Erlotinib	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Sorafenib Monotherapy

Serious: 114/203 (56%)

Deaths: 62/203

Sorafenib+Erlotinib

Serious: 1/1 (100%)

Deaths: 0/1

Serious adverse events (128 terms)

Reaction	System	Sorafenib Monotherapy	Sorafenib+Erlotinib
Pneumonia	Infections and infestations	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Death	General disorders	—	—
Sepsis	Infections and infestations	—	—
Myocardial infarction	Cardiac disorders	—	—
Multiple organ dysfunction syndrome	General disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—
Acute myocardial infarction	Cardiac disorders	—	—
Angina unstable	Cardiac disorders	—	—
Sudden death	General disorders	—	—
Cholelithiasis	Hepatobiliary disorders	—	—
Hepatic failure	Hepatobiliary disorders	—	—
Acute kidney injury	Renal and urinary disorders	—	—
Renal failure	Renal and urinary disorders	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—
Cardiac failure	Cardiac disorders	—	—
Ascites	Gastrointestinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Duodenal ulcer	Gastrointestinal disorders	—	—
Gastric ulcer	Gastrointestinal disorders	—	—
Pyrexia	General disorders	—	—

Other adverse events (47 terms — click to expand)

Reaction	System	Sorafenib Monotherapy	Sorafenib+Erlotinib
Diarrhoea	Gastrointestinal disorders	—	—
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	—	—
Fatigue	General disorders	—	—
Hypertension	Vascular disorders	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Lipase increased	Investigations	—	—
Stomatitis	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—
Weight decreased	Investigations	—	—
Amylase increased	Investigations	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Alanine aminotransferase increased	Investigations	—	—
Aspartate aminotransferase increased	Investigations	—	—
Haemoglobin decreased	Investigations	—	—
Vomiting	Gastrointestinal disorders	—	—
Asthenia	General disorders	—	—
Platelet count decreased	Investigations	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—
Lymphopenia	Blood and lymphatic system disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Dyspepsia	Gastrointestinal disorders	—	—
Hypocalcaemia	Metabolism and nutrition disorders	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—
Proteinuria	Renal and urinary disorders	—	—
Renal failure	Renal and urinary disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—
Ascites	Gastrointestinal disorders	—	—
Insomnia	Psychiatric disorders	—	—
Dysphonia	Respiratory, thoracic and mediastinal disorders	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—
Hypothyroidism	Endocrine disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—

Most-reported serious reactions: Pneumonia, Anaemia, Death, Sepsis, Myocardial infarction, Multiple organ dysfunction syndrome, Abdominal pain, Hepatocellular carcinoma.

Data from ClinicalTrials.gov NCT00625378 adverse events section.

Sponsor's own description

The primary purpose of program was to enable patients, currently receiving sorafenib (Nexavar) in a Bayer/Onyx sponsored clinical trial, to continue sorafenib treatment after their respective study had met its primary endpoint and/or had reached the end as defined in the original protocol. Patients were able to continue treatment until (i) the treating physician felt the patient was no longer benefiting from the treatment or (ii) the treatment becomes commercially available and reimbursed for the respective indication as applicable in the country in which the patient lived and the patient could obtain suitable amounts of drug for treatment through standard mechanisms of commercial availability (ie, there should be no interruption in the patient's treatment schedule when switching to commercially available product) or (iii) the patient could join a Post-Trial-Access Program, another study or can receive sorafenib through any other mechanism (e.g. local access program) in accordance with local legal and compliance rules, with no cost to the patient with respect to sorafenib. An additional objective was the assessment of the safety of Nexavar or Nexavar combination treatment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Sorafenib (Nexavar, BAY43-9006)

Trials testing the same drug.

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Other Bayer trials

Trials by the same sponsor.

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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 NCT00625378 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 1 September 2022

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/NCT00625378.

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

NCT00625378: STEP

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (128 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Sorafenib (Nexavar, BAY43-9006)

Other recruiting trials for Neoplasms

Other Bayer trials

Verify against primary sources