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Sponsored by: |
Lung Cancer Group Cologne |
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Information provided by: | Lung Cancer Group Cologne |
ClinicalTrials.gov Identifier: | NCT00933777 |
A phase I clinical trial to evaluate the safety of combined sorafenib and everolimus treatment in patients with relapsed solid tumors.
Condition | Intervention | Phase |
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Relapsed and/or Refractory Solid Tumors |
Drug: Combination of sorafenib and everolimus |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | SORAVE-Sorafenib and Everolimus in Solid Tumors. A Phase I Clinical Trial to Evaluate the Safety of Combined Sorafenib and Everolimus Treatment in Patients With Relapsed Solid Tumors. |
Estimated Enrollment: | 36 |
Study Start Date: | July 2009 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Therapy with everolimus and sorafenib: Experimental
Treatment with defined dose of sorafenib of 2x400 mg with increasing dose of everolimus (2.5 mg, 5 mg, 7.5 mg, 10 mg)
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Drug: Combination of sorafenib and everolimus
Combination of defined dose of sorafenib (2x400 mg) with increasing dose of everolimus (2.5 mg, 5 mg, 7.5 mg, 10 mg)
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Patients will be recruited to receive combination of defined sorafenib dose (2x400mg) with increasing dose of everolimus (2.5mg, 5mg, 7.5mg, 10mg). There will be a run-in phase of 14 days of everolimus followed by combination sorafenib+everolimus starting from day 15. The combination will be continued as long as it is tolerated by the patient and the patient benefits from the treatment according to RECIST criteria. The maximal tolerated dose will be establish in 3+3 design. Patients will be recruited sequentially at least 14 days apart.
The next dose level according to 3+3 design will be initiated if all patients on the previous dose level reach day 29.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
Exclusion Criteria:
Contact: Juergen Wolf, MD, Prof. | 0049-221-478-89050 | lungenkrebs@uk-koeln.de |
Contact: Lucia Nogova, MD | 0049-221-478-87033 | lungenkrebs@uk-koeln.de |
Germany | |
Center for Integrated Oncology, Dep.I of Internal Medicine, University Hospital Cologne | |
Cologne, Germany |
Principal Investigator: | Juergen Wolf, MD, Prof. | Lung Cancer Group Cologne, Center for Integrated Oncology, Dep.I of Internal Medicine, University Hospital Cologne, Germany |
Responsible Party: | Lung Cancer Group Cologne, University Hospital Cologne, Germany ( Prof. Juergen Wolf, MD ) |
Study ID Numbers: | SORAVE |
Study First Received: | July 2, 2009 |
Last Updated: | July 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00933777 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Everolimus Immunologic Factors Protein Kinase Inhibitors Immunosuppressive Agents Sorafenib |
Everolimus Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Enzyme Inhibitors Protein Kinase Inhibitors Immunosuppressive Agents Sorafenib Pharmacologic Actions |