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Phase I-II, Not-Randomized, Multicenter Clinical Trial to Evaluate Safety and Efficacy of Sorafenib (BAY-43-9006) in Combination With Ifosfamide in Soft Tissue Sarcoma.

Phase 1/Phase 2
18 Years
72 Years
Open (Enrolling)
Soft Tissue Sarcoma

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Trial Information

Phase I-II, Not-Randomized, Multicenter Clinical Trial to Evaluate Safety and Efficacy of Sorafenib (BAY-43-9006) in Combination With Ifosfamide in Soft Tissue Sarcoma.

Inclusion Criteria:

1. Advanced Soft Tissue Sarcoma histologically proven, excluding the following subtypes:
chondrosarcoma, osteosarcoma, Ewing's sarcoma, and embryonal rhabdomyosarcoma.

2. Patients must have been previously treated with Anthracycline. However, patients not
eligible for Anthracycline treatment can be included.Prior treatment with Ifosfamide
is not allowed, except if it was administered as adjuvant therapy.

3. Patients must be > 18 and < 72 years old.

4. Patients must have ECOG performance status 0 to 1 on fase I.

5. Patients must have ECOG performance status 0 to 2 on fase II.

6. Patients must have measurable disease. Progression must be documented during the last
month pre-study entry. No prior radiotherapy in the indicator lesion is allowed.

7. Adequate bone marrow, renal and hepatic function

- hemoglobin ³ 9.0 g/dl

- absolute neutrophil count ³ 1,500/mm3

- platelet count ³ 100,000/mm3

- total bilirubin £ 1.5 times the upper limit of normal

- ALT and AST £ 2.5 times the upper limit of normal (£ 5 x upper limit of normal
for patients with liver involvement)

- INR £ 1.5 and aPTT within normal limits

- serum creatinine £ 1.5 the upper limit of normal

8. Signed informed consent prior to any study specific procedures

Exclusion Criteria:

1. Patients with previous chemotherapy or radiotherapy, within 3 weeks prior to study

2. Pregnant or breast feeding patients. Women of childbearing potential must have a
negative pregnancy test performed within 7 days prior to the start of treatment. Both
men and women enrolled in this trial must use adequate barrier birth control measures
during the course of the trial.

3. Life expectancy of less than 12 weeks.

4. General medical or psychological conditions that would preclude appropriate informed
consent or compliance with the protocol.

5. Substance abuse, medical, psychological or social conditions that may interfere with
the patients participation in the study.

6. Previous cancer that is distinct in primary site or histology from NSCLC except
cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors (Ta
and Tis) or any cancer curatively treated > 3 years prior to study entry.

7. Concurrent treatment with other anti-cancer therapy.

8. Concurrent treatment with other experimental drugs (within 30 days prior to study

9. Significant weight loss (> or equal 10% body weight during preceding 6 weeks).

10. Major surgery, open biopsy or significant traumatic injury within 4 weeks of first
dose of study drug.

11. Biological modifying agents such as G-CSF administered within 3 weeks prior to study

12. Known or suspected allergy to sorafenib or ifosfamide.

13. Evidence or history of bleeding diathesis or coagulopathy.

14. Therapeutic anticoagulation with Vitamin K antagonists such as warfarin or with
heparins or heparinoids. Low dose warfarin is permitted if INR is <1.5. Low dose
aspirin is permitted.

15. Thrombotic or embolic events such as cerebrovascular accident including transient
ischemic attacks within the past 6 months.

16. Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic
pressure > 90 mm Hg, despite optimal medical management.

17. Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have
unstable angina or new-onset angina (began within the last 3 months) or myocardial
infarction within the last 6 months.

18. Active clinically serious infections > CTCAE Grade 2.

19. Serious, non-healing wound, ulcer, or bone fracture.

20. Concomitant treatment with ketoconazole, itraconazole, ritonavir, rifampicin and St.
John´s Wort.

21. Known HIV infection or chronic hepatitis B or C.

22. Known brain metastasis. Patients with neurological symptoms should undergo a CT
scan/MRI of the brain to exclude brain metastasis.

23. Any other condition that could compromise patient's security and/or study's

24. Known or suspected allergy to mesna or tiolic agents.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: Safety profile and to determine maximum tolerated dose (MTD) / Recommended Dose (DR) of Sorafenib in combination with Ifosfamide. Phase II: Activity profile evaluating of the combination in patients with advanced soft tissue sarcoma.

Outcome Time Frame:

Phase II: Progression free rate: at 3 and 6 months

Safety Issue:


Principal Investigator

Xavier Garcia del Muro, MD

Investigator Role:

Study Director

Investigator Affiliation:

Grupo Español de Investigacion en Sarcomas (GEIS)


Spain: Spanish Agency of Medicines

Study ID:




Start Date:

October 2007

Completion Date:

April 2010

Related Keywords:

  • Soft Tissue Sarcoma
  • Sarcoma
  • Sorafenib
  • GEIS
  • Sarcoma