A Phase 2 Study of AMG 479 in Relapsed or Refractory Ewing's Family Tumor and Desmoplastic Small Round Cell Tumors
This study is ongoing, but not recruiting participants.
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00563680
First received: November 21, 2007
Last updated: August 11, 2011
Last verified: August 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Askin's Tumors Desmoplastic Small Round Cell Tumors Estraosseous Ewing's Tumor Ewing's Family Tumor Ewing's Sarcoma Primitive Neuroectodermal Tumors (PNETs) Sarcoma |
Drug: AMG 479 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2 Study of AMG 479 in Relapsed or Refractory Ewing's Family Tumor and Desmoplastic Small Round Cell Tumors |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Objective response rate (Partial Response [PR] or Complete Response [CR]) as determined by RECIST [ Time Frame: From screening to disease progression ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Assess the safety and tolerability of AMG 479 [ Time Frame: From informed consent to the End of Study/Safety Follow-Up Visit ] [ Designated as safety issue: Yes ]
- Assess the duration of response [ Time Frame: From screening to disease progression ] [ Designated as safety issue: No ]
- Assess the clinical benefit rate [ Time Frame: From screening to disease progression ] [ Designated as safety issue: No ]
- Assess the progression free survival and overall survival [ Time Frame: From screening to disease progression ] [ Designated as safety issue: No ]
| Enrollment: | 38 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | September 2011 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Exploratory Cohort
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.
|
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.
|
|
Experimental: Main Cohort
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.
|
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.
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
- Measurable disease as defined by RECIST.
- Documented failure of at least one prior chemotherapy regimen for their disease.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
Demographic
- Males or females ≥ 16 years old.
- Signed written informed consent.
- Able to comply with visits and procedures.
Laboratory
- Willing to provide existing and/or newly acquired tumor samples.
- Diabetic Subjects (Type 1 or 2) must have HgbA1c < 8.0% and fasting blood glucose level < 160 mg/dL.
General
- Must be willing and able to use birth control (double barrier protection or abstinence) during and for 6 months after the study
- Prior exposure to another anti-IGF-1R therapy will only be allowed for a limited number of additional subjects (up to 10) in an exploratory cohort
Exclusion Criteria
Disease Related
- Known brain metastasis.
- History of bleeding diathesis.
- History of another malignancy.
- History of chronic hepatitis.
- Documented prior history of human immunodeficiency virus.
Laboratory
- Absolute neutrophil count < 1.5 x109/L.
- Platelet count < 100 x 109/L.
- Hemoglobin < 9 g/dL.
- PT > 1.5 x institutional upper limit of normal (IULN) or PTT > 1.0 x IULN.
- Serum creatinine > 1.5 x IULN.
- Aspartate aminotransferase (AST) > 2.5 x IULN or Alanine aminotransferase (ALT) > 2.5 x IULN (> 5.0 x if liver metastases present).
- Total bilirubin > 1.5 IULN (> 3.0 x with documented Gilbert's Syndrome)
Medication
- Antitumor treatment within 21 days of Study Day 1.
- Anticoagulation therapy within 28 days of Study Day 1.
- Major surgery within 28 days of Study Day 1.
General
- Other investigational procedures are excluded.
- Inability to tolerate intravenous administration.
- Subject is pregnant (eg, positive HCG test) or is breast feeding.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00563680 History of Changes |
| Other Study ID Numbers: | 20060283 |
| Study First Received: | November 21, 2007 |
| Last Updated: | August 11, 2011 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Australia: Therapeutic Goods Administration Canada: Health Products and Food Branch Canada: Institutional Review Board United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Amgen:
|
AMG 479 IGF-1R Insulin-like growth factor |
Insulin-like growth factor receptor Ewing's Sarcoma |
Additional relevant MeSH terms:
|
Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Desmoplastic Small Round Cell Tumor Sarcoma, Ewing's Neuroectodermal Tumors, Primitive, Peripheral Sarcoma Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue |
Neoplasms, Neuroepithelial Neoplasms, Glandular and Epithelial Neoplasms, Connective and Soft Tissue Osteosarcoma Neoplasms, Bone Tissue Neoplasms, Connective Tissue Mitogens Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013