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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.

Phase 1
18 Years
Open (Enrolling)
Relapsed and/or Refractory Solid Tumors

Thank you

Trial Information

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.

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.

Inclusion Criteria:

- Patients with solid tumors relapsed after and/or refractory to standard therapy

- ≥ 18 years of age

- Performance status ECOG 0-2

- Life expectancy of at least 12 weeks

- Subjects with at least one measurable (CT or MRI) lesion

- Adequate bone marrow, liver and renal function as assessed by the following
laboratory requirements to be conducted within 7 days prior to screening:

- Hemoglobin ≥ 9.0 g/dL

- Absolute neutrophil count (ANC) ≥ 1,500 /mm3

- Platelet count ≥ 100 000/µL

- Total bilirubin ≤ 1,5x upper limit of normal (ULN)

- ALT and AST ≤ 2,5x ULN (≤ 5x ULN for patients with liver involvement)

- Alkaline phosphatase < 4x ULN

- Potassium within normal limits (WNL) or correctable with supplements

- Total calcium (corrected for serum albumin) WNL or correctable with supplements

- Magnesium WNL or correctable with supplements

- PT-INR/PTT < 1.5 x ULN [Patients who are being therapeutically anticoagulated
with an agent such as coumadin or heparin will be allowed to participate
provided that no prior evidence of underlying abnormality in these parameters

- Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance (CrCl) ≥
50 ml/min calculated by either Cockcroft-Gault or by 24 hours urine collection

- More than 14 days since previous systemic therapy, radiotherapy and surgery

- Negative urine or serum HCG in women of childbearing potential

- Signed and dated informed consent before the start of specific protocol procedures

Exclusion Criteria:

- Squamous cell carcinoma histology in non-small cell lung cancer

- History of cardiac disease: congestive heart failure > NYHA class 2; active Coronary
Arterial Disease (CAD), (MI more than 6 months prior to study entry is allowed);
cardiac arrythmias requiring anti-arrythmic therapy (except, when controlled by beta
blockers or digoxin) or uncontrolled hypertension

- Active skin, mucosa, ocular or GI disorders of grade > 1

- Uncontrolled diabetes

- ≥ grade 3 hypercholesterolemia/hypertriglyceridemia or ≥ grade 2 hypercholesterolemia
/ hypertriglyceridemia with history of CAD (despite lipid lowering treatment if

- Impairment of gastrointestinal function or gastrointestinal disease that may
significantly alter the absorption of everolimus and sorafenib (e.g. ulcerative
disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small
bowel resection)

- History of HIV infection or previously sero-positive for the virus

- History of Hepatitis B or/and C or previously sero-positive for the Hepatitis B
or/and C virus

- Leptomeningeal or uncontrolled brain metastases, including patients who continue to
require glucocorticoids or intrathecal chemotherapy for brain or leptomeningeal
metastases (documented by lumbar puncture)

- Treatment with any other investigational drugs within the previous 14 days

- Patients with seizure disorder requiring anti-epileptics

- History of organ allograft

- Patients with evidence or history of bleeding diathesis

- Patients undergoing renal dialysis

- Previous treatment with mTOR inhibitors and/or known hypersensitivity to mTOR

- Past or current history of cancer other than the entry diagnosis EXCEPT cervical
carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis
& T1] or any cancer curatively treated > 3 years prior to study entry

- Any person being in an institution on assignment of the respective authority

- Any medical, mental or psychological condition which in the opinion of the
investigator would not permit the patient to complete the study or understand the
patient information

- Women who are pregnant or breast feeding, or women who are able to conceive and
unwilling to practice an effective method of birth control (safe hormonal methods
or/and barrier contraception) during study and 2 months after the last study drug

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To define a feasible treatment schedule for the combination therapy with sorafenib and everolimus

Outcome Time Frame:

July 2009 - January 2011

Safety Issue:


Principal Investigator

Juergen Wolf, MD, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lung Cancer Group Cologne, Center for Integrated Oncology, Dep.I of Internal Medicine, University Hospital Cologne, Germany


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

July 2009

Completion Date:

June 2013

Related Keywords:

  • Relapsed and/or Refractory Solid Tumors
  • Neoplasms