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

NCT00563680 | Completed Phase 2

• 2 other identifiers: 20060283QUILT-3.025
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Objective response rate (Partial Response [PR] or Complete Response [CR]) as determined by RECIST

  From screening to disease progression

Secondary Outcomes (4)

• 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

• Assess the clinical benefit rate

  From screening to disease progression

• Assess the progression free survival and overall survival

  From screening to disease progression

Study Arms (2)

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.

Drug: AMG 479

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.

Drug: AMG 479

Interventions

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.

Exploratory Cohort; Main Cohort

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NantCell, Inc.: lead

Related 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.

  PMID: 22508822 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Askin Tumor; Sarcoma, Ewing; Neuroectodermal Tumors, Primitive; Sarcoma; Insulin-Like Growth Factor I, Resistance To

Interventions

ganitumab

Condition Hierarchy (Ancestors)

Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2007
• First Posted: November 26, 2007
• Study Start: October 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2012
• Last Updated: October 27, 2016

Record last verified: 2016-10