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| ID | Type | Description | Link |
|---|---|---|---|
| QUILT-3.025 | Other Identifier | NantCell, Inc. |
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Single-arm, open-label study of AMG 479 in up to 35 subjects with Ewing's Family Tumors (EFTs) and Desmoplastic Small Round Cell Tumors (DSRCTs) who have progressed or recurred after at least one prior chemotherapy regimen. An exploratory cohort of an additional up to 10 subjects with prior exposure to anti-IGF-1R therapy and who have progressed or recurred after at least one prior chemotherapy regimen will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exploratory Cohort | Experimental | If a total of two or more responses (partial and complete) in EFTs/DSRCTs are documented in this or the ongoing phase 1 study (20050118), then the study will allow enrollment of up to 10 additional EFT/DSRCT subjects who have been exposed to prior anti-IGF-1R targeting therapy. |
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| Main Cohort | Experimental | Subjects with relapsed Ewing's Family Tumors (EFTs) and Desmoplastic Small Round Cell Tumors (DSRCTs) who have not received prior anti-IGF-1R therapy will receive AMG 479 at 12mg/kg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 479 | Drug | AMG 479 is a fully human monoclonal antibody (IgG1) against the insulin-like growth factor receptor-1 (IGF-1R). IGF-1R signaling has been shown to play a critical role in the survival of cancer cells. AMG 479 inhibits the binding of both IGF-1 and IGF-2 to IGF-1R, thus inhibiting ligand-dependent receptor activation. Inhibition of IGF-1R signaling with AMG 479 provides a potential mechanism for inhibiting tumor growth and survival. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (Partial Response [PR] or Complete Response [CR]) as determined by RECIST | From screening to disease progression |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the safety and tolerability of AMG 479 | From informed consent to the End of Study/Safety Follow-Up Visit | |
| Assess the duration of response | From screening to disease progression | |
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Male and female subjects ≥ 16 years of age with a diagnosis of EFT or DSRCT who have relapsed or progressed after at least one prior chemotherapeutic regimen will be eligible for this study.
Before any study-specific procedure, the appropriate written informed consent must be obtained.
Inclusion Criteria:
Disease Related Subjects with pathological or histological diagnosis of Ewing's Family Tumor or Desmoplastic Small Round Cell Tumor.
Demographic
Laboratory
General
Exclusion Criteria
Disease Related
Laboratory
Medication
General
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22508822 | Background | Tap WD, Demetri G, Barnette P, Desai J, Kavan P, Tozer R, Benedetto PW, Friberg G, Deng H, McCaffery I, Leitch I, Badola S, Chang S, Zhu M, Tolcher A. Phase II study of ganitumab, a fully human anti-type-1 insulin-like growth factor receptor antibody, in patients with metastatic Ewing family tumors or desmoplastic small round cell tumors. J Clin Oncol. 2012 May 20;30(15):1849-56. doi: 10.1200/JCO.2011.37.2359. Epub 2012 Apr 16. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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|
| Assess the clinical benefit rate |
| From screening to disease progression |
| Assess the progression free survival and overall survival | From screening to disease progression |
| ID | Term |
|---|---|
| C563168 | Askin Tumor |
| D012512 | Sarcoma, Ewing |
| D018242 | Neuroectodermal Tumors, Primitive |
| D012509 | Sarcoma |
| C564816 | Insulin-Like Growth Factor I, Resistance To |
| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| C545764 | ganitumab |
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