Trials / Completed
CompletedNCT00563680
QUILT-3.025: A Phase 2 Study of AMG 479 in Relapsed or Refractory Ewing's Family Tumor and Desmoplastic Small Round Cell Tumors
A Phase 2 Study of AMG 479 in Relapsed or Refractory Ewing's Family Tumor and Desmoplastic Small Round Cell Tumors
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- NantCell, Inc. · Industry
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Askin's Tumors
- Desmoplastic Small Round Cell Tumors
- Estraosseous Ewing's Tumor
- Ewing's Family Tumor
- Ewing's Sarcoma
- Primitive Neuroectodermal Tumors (PNETs)
- Sarcoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AMG 479 | 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. |
Timeline
- Start date
- 2007-10-01
- Primary completion
- 2009-08-01
- Completion
- 2012-08-01
- First posted
- 2007-11-26
- Last updated
- 2016-10-27
Source: ClinicalTrials.gov record NCT00563680. Inclusion in this directory is not an endorsement.