QUILT-3.025: A Phase 2 Study of AMG 479 in Relapsed or Refractory Ewing's Family Tumor and Desmoplastic Small Round Cell Tumors

Sarcoma Clinical Trial

Official title:

A Phase 2 Study of AMG 479 in Relapsed or Refractory Ewing's Family Tumor and Desmoplastic Small Round Cell Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00563680
• Other study ID #: 20060283
• Secondary ID: QUILT-3.025
• Status: Completed
• Phase: Phase 2
• First received: November 21, 2007
• Last updated: October 26, 2016
• Start date: October 2007
• Est. completion date: August 2012

Study information

• Verified date: October 2016
• Source: NantCell, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: Therapeutic Goods AdministrationCanada: Health Products and Food BranchCanada: Institutional Review BoardUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 2012
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Askin's Tumors
• Desmoplastic Small Round Cell Tumor
• Desmoplastic Small Round Cell Tumors
• Estraosseous Ewing's Tumor
• Ewing's Family Tumor
• Ewing's Sarcoma
• Neoplasms
• Neuroectodermal Tumors
• Neuroectodermal Tumors, Primitive
• Primitive Neuroectodermal Tumors (PNETs)
• Sarcoma
• Sarcoma, Ewing

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NantCell, Inc.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (Partial Response [PR] or Complete Response [CR]) as determined by RECIST		From screening to disease progression	No
Secondary	Assess the safety and tolerability of AMG 479		From informed consent to the End of Study/Safety Follow-Up Visit	Yes
Secondary	Assess the duration of response		From screening to disease progression	No
Secondary	Assess the clinical benefit rate		From screening to disease progression	No
Secondary	Assess the progression free survival and overall survival		From screening to disease progression	No

External Links

•   AmgenTrials clinical trials website