Sorafenib Long Term Extension Program (STEP) - STEP

Phase 1

• Conditions: Various Cancer indication/types (e.g. Renal Cell Carcinoma, Hepatoma Carcinoma, Melanoma and other cancer types). Patients who remain actively treated in a Bayer/Onyx sponsored Clinical Trial that has reached its statistical, regulatory and/or study end and who, in the opinion of the Investigator, still benefiting from treatment, will be eligible for entry into this program.; MedDRA version: 9.1Level: HLGTClassification code 10027655Term: Miscellaneous and site unspecified neoplasms malignant and unspecified

• Registration Number: EUCTR2007-002604-17-IT
• Lead Sponsor: BAYER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-12-11
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2000

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 as a monotherapy in their originating protocol. Patients who were being treated with sorafenib in combination with other chemotherapies in the original study, but continued on single agent sorafenib after discontinuation of the combination agent will be eligible.
Patients who have completed the End of Treatment assessments in their originating study. Every effort should e made to conduct the End of Treatment visit such that the patient does not have any interruption in sorafenib dosing.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any condition that is unstable or which 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>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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified