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

NCT ID: NCT00563680

Last Updated: 2016-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2012-08-31

Brief 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

Keywords

AMG 479; IGF-1R; Insulin-like growth factor; Insulin-like growth factor receptor; Ewing's; Sarcoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

AMG 479

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

AMG 479

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Before any study-specific procedure, the appropriate written informed consent must be obtained.

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NantCell, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Countries

Australia; Canada; United States

References

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.

Reference Type: BACKGROUND

PMID: 22508822 (View on PubMed)

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

QUILT-3.025

Identifier Type: OTHER

Identifier Source: secondary_id

20060283

Identifier Type: -

Identifier Source: org_study_id