A Phase 1b/2 Study of AMG 655 in Combination With Doxorubiicn for the First-Line Treatment of Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma
- Conditions
- weke delenSoft Tissue Sarcoma
- Registration Number
- NL-OMON32142
- Lead Sponsor
- Amgen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
Histologically or cytologically confirmed soft tissue sarcoma
Locally advanced, recurrent, or metastatic, unresectable disease
Intermediate or high grade disease (grade 2 or 3 according to the Federation Nationale des Centres de Lutte Contre le Cancer (FNCLCC) grading sysem)
The following tumor types ar not eligible: Alveolar soft part sarcoma, Clear cell sarcoma (melanoma of soft parts), Chondrosarcoma, Desmoid tumor, Desmoplastic small round cell tumor, Embryonal rhabdomyosarcoma, Ewing sarcoma / Primitive neuroectodermal tumor (PNET), Gastrointestinal stroma tumor (GIST), Kaposi sarcoma, Mesothelioma, Mixed mesodermal tumor, Neuroblastoma, Osteosarcoma.
History or known presence of uncontrolled central nervous system (CNS) metastasis
Prior Chemotherapy or investigational agent(s) for the treatment of locally advanced or metastatic, unresectable soft tissue sarcoma (prior neo-adjuvant or adjuvant therapy is allowed, provided there was no disease progression with 6 months after completion of treatment)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Part 1 (phase 1b): To identify a dose of AMG 655 in combination with<br /><br>doxorubicin that is safe and tolerated as determined by the incidence of dose<br /><br>limiting toxicity.<br /><br><br /><br>Part 2 (phase 2): To estimate the efficacy, as measured by progression-fee<br /><br>survival, AMG 655 at the dose selected in part 1, in combination with<br /><br>doxorubicin.</p><br>
- Secondary Outcome Measures
Name Time Method