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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


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
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