Clinical trial · Interventional
S0505 Sorafenib in Treating Patients With Advanced Soft Tissue Sarcomas
Phase II Trial of BAY-9006 (NSC #724772) in Advanced Soft Tissue Sarcomas
NCT00217620CI-TRIAL-00014534completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with advanced soft tissue sarcomas.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- sorafenib
- description
- sorafenib
- interventionNames
- Drug: sorafenib
Primary outcomes (1)
- measure
- Objective Response (Confirmed, Complete and Partial)
- timeFrame
- Assessment performed every eight weeks until progression.
- description
- Partial response (PR) is greater than or equal to 30% decrease under baseline of sum of longest diameters of all target measurable lesions; No unequivocal progression of non-measurable disease; No new lesions. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration. Stable disease does not qualify for CR, PR, Progression or Symptomatic Deterioration. Progressive disease is any one or more of the following: 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed; unequivocal progression of non-measurable disease; appearance of any new lesion/site; death due to disease without prior documentation of progression and without symptomatic deterioration. Assessment inadequate is progression or symptomatic deterioration has not been documented, and one or more target measurable lesions have not been assessed or inconsistent assessment methods were used.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed soft tissue sarcoma of 1 of the following histologies:
* Angiosarcoma, cutaneous or visceral
* Malignant hemangiosarcoma
* Malignant hemangiopericytoma
* Grade 3-4 leiomyosarcoma
* Grade 3-4 liposarcoma
* Must have evidence of unresectable residual disease, metastatic disease, or recurrent disease by radiography
* Measurable disease by x-ray, scans, or physical examination
* Archived paraffin-embedded tumor sections available
* No known brain metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-1
Life expectancy
* Not specified
Hematopoietic
* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver metastases)
* Bilirubin normal (≤ 2.5 times ULN if due to liver metastases)
* PT, PTT, and INR normal
Renal
* Creatinine normal OR
* Creatinine clearance ≥ 60 mL/min
Cardiovascular
* No history of thromboembolic disease
* No uncontrolled hypertension
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Able to swallow oral medication
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* At least 28 days since prior chemotherapy (42 days for carmustine or mitomycin) and recovered
* Prior adjuvant chemotherapy allowed
* No more than 1 prior chemotherapy regimen for metastatic disease
Endocrine therapy
* Not specified
Radiotherapy
* At least 28 days since prior radiotherapy and recovered
* Must have evidence of disease progression within, or measurable disease outside of, the radiation field after completion of radiotherapy
Surgery
* At least 28 days since prior major surgery and recovered
Other
* No prior sorafenib
* No prior inhibitor of VEGFR or MAPK pathway
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent investigational agents
* No concurrent therapeutic anticoagulation
* No concurrent administration of any of the following medications:
* Rifampin
* Hypericum perforatum (St. John's wort)
* Cytochrome P450 enzyme-inducing antiepileptic drugs, including any of the following:
* Phenytoin
* Carbamazepine
* PhenobarbitalReferences
Publications (1)
- RESULTRyan CW, von Mehren M, Rankin CJ, et al.: Phase II intergroup study of sorafenib (S) in advanced soft tissue arcomas (STS): SWOG 0505. [Abstract] J Clin Oncol 26 (Suppl 15): A-10532, 2008.