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Phase 1 Dose Escalation Study With Sorafenib in Combination With Sirolimus in Patients With Solid Tumor

Phase 1
18 Years
Not Enrolling
Advanced Solid Tumor, Refractory to Standard Therapies

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Trial Information

Phase 1 Dose Escalation Study With Sorafenib in Combination With Sirolimus in Patients With Solid Tumor

Inclusion Criteria:

- Patients with histological or cytological confirmed advanced solid tumor, which is
refractory to standard therapies or for which no standard therapy exists and for
which there is a rationale for the therapeutic use of a combination of sorafenib and
sirolimus (especially metastic RCC, malignant melanoma, HCC, NSCLC, pancreatic
cancer, hormone refractory prostate cancer).

- Men or women of at least 18 years

- Patients who have an ECOG status of 0 or 1

- Patients who have a life expectancy of at least 12 weeks

- Adequate bone marrow, liver and renal function

- Negative pregnancy test for female patients of childbearing potential

- Women and men enrolled into this trial must use adequate birth control measures
during the course of the trial.

- Signed informed consent

Exclusion Criteria:

- History of serious cardiac disease

- Active clinically serious bacterial, viral or fungal infections (> grade 2).

- Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B
or C.

- Clinically symptomatic brain or meningeal metastasis.

- Patients with seizure disorders requiring medication (such as steroids or

- Patients with evidence or history of bleeding diathesis.

- Substance abuse, medical, psychological or social conditions that may interfere with
the patients participation in the study or evaluation of the study results.

- Concomitant treatment with strong CYP3A4 inductors (such as rifampicin, St. John´s
Wort) or CYP3A4 inhibitors (such as ketoconazole, voriconazole, itraconazole,
diltiazem, verapamil, erythromycin). Moderate or weak CYP3A4 modifiers should be used
concomitantly only after careful assessment of risk-benefit ratio. Concomitant use of
carbamazepine, phenobarbital, phenytoin or chronic use of dexamethasone is excluded

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

identify the recommended doses for the combination of sorafenib and sirolimus for subsequent phase II studies

Principal Investigator

C.M.L. van Herpen, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UMC St Radboud


Netherlands: Medical Ethics Review Committee (METC)

Study ID:

UMCNONCO 2006_01



Start Date:

June 2007

Completion Date:

Related Keywords:

  • Advanced Solid Tumor
  • Refractory to Standard Therapies