Clinical trial · Interventional
Sorafenib Long Term Extension Program
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sorafenib (Nexavar, BAY43-9006)
- description
- Participants receive single-agent sorafenib at the same dose and schedule as in their original clinical trials.
- interventionNames
- Drug: Sorafenib (Nexavar, BAY43-9006)
Primary outcomes (10)
- measure
- Sorafenib Treatment Duration Within STEP
- timeFrame
- 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
- description
- 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.
- measure
- Number of Participants With New Treatment-emergent Adverse Events (TEAEs)
- timeFrame
- From signing the informed consent form (ICF) in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Patients, who are participating in a previous Bayer/Onyx sponsored study that has reached its endpoint (statistical and regulatory or study end), and who are, in the opinion of the Investigator, expected to continue to have an overall positive benefit/risk from continuing treatment. * Patients who have signed informed consent for this long term extension program. * Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation, including the 30 days period after last study drug dosing. The investigator should advise the patient how to achieve an adequate contraception. * Women of childbearing potential who have a negative pregnancy test within 7 days of the first dose of sorafenib in this long term extension program. * Patient is receiving sorafenib (Nexavar) as a monotherapy in their originating protocol. Patients who were being treated with sorafenib (Nexavar) in combination with other chemotherapies in the original study, but continued on single agent sorafenib (Nexavar) after discontinuation of the combination agent will be eligible. * Patient who are receiving concurrent combination with sorafenib (Nexavar) and TACE (transarterial chemoembolization) in their originating study will be eligible. * Patients who are receiving concurrent combination with sorafenib (Nexavar) and capecitabine in their originating Study 12444 (RESILIENCE) will be eligible. * Patients who are receiving concurrent combination with sorafenib (Nexavar) and erlotinib in their originating study 12917 (SEARCH) were eligible. * Patients who have completed the End of Treatment assessments in their originating study. Every effort should be made to conduct the End of Treatment visit such that the patient does not have any interruption of sorafenib dosing. Exclusion Criteria: * Any condition that is unstable or that could jeopardize the safety of the patient (please refer to the Investigator Brochure and product labeling safety sections). * History of cardiac disease: congestive heart failure \> New York Heart Association (NYHA) Class 2 or uncontrolled hypertension. * Myocardial infarction (MI) within the last 3 months. * Symptomatic metastatic brain or meningeal tumors . * Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors ( Ta, Tis \&T1) or any cancer curatively treated \> 5 years prior to study entry. * Patients with seizure disorder requiring medication (such as steroid anti-epileptics). * Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results. * Any condition which could jeopardise the safety of the patient and his/her compliance in the study. Excluded therapies and medications, previous and concomitant: * Concurrent anti-cancer chemotherapy, except transarterial chemoembolization (TACE) and capecitabine * Concurrent immunotherapy (including monoclonal antibodies), during or within 30 days prior to start of study drug * Concurrent hormonal therapy, except for bisphosphonates,during or within 30 days prior to start of study drug * Concomitant Rifampicin and St John's Wort (Warfarin may be used only with very close monitoring) * Radiotherapy during study or within 3 weeks of start of study drug. \[Palliative radiotherapy will be allowed\] * Concomitant use of potent inhibitors of CYP3A4 including ketoconazole, itraconazole and ritonavir. Consumption of grapefruit juice should also be avoided.
References
Publications (0)
Data not yet available