Clinical trial NCT00563680: QUILT-3.025: A Phase 2 Study of AMG 479 in Relapsed or Refractory Ewing's Family Tumor and Desmoplastic Small Round Cell Tumors
Official title: A Phase 2 Study of AMG 479 in Relapsed or Refractory Ewing's Family Tumor and Desmoplastic Small Round Cell Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: NantCell, Inc.
Sponsor class: INDUSTRY
First posted: 2007-11-26
Enrollment: 38
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Objective response rate (Partial Response [PR] or Complete Response [CR]) as determined by RECIST
timeFrame: From screening to disease progression
Secondary outcomes:
measure: Assess the safety and tolerability of AMG 479
timeFrame: From informed consent to the End of Study/Safety Follow-Up Visit
measure: Assess the duration of response
timeFrame: From screening to disease progression
measure: Assess the clinical benefit rate
timeFrame: From screening to disease progression
measure: Assess the progression free survival and overall survival
timeFrame: From screening to disease progression
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.