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

Primary Purpose

Askin's Tumors, Desmoplastic Small Round Cell Tumors, Estraosseous Ewing's Tumor

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

AMG 479

About this trial

This is an interventional treatment trial for Askin's Tumors focused on measuring AMG 479, IGF-1R, Insulin-like growth factor, Insulin-like growth factor receptor, Ewing's, Sarcoma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Exploratory Cohort

Main Cohort

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Assess the safety and tolerability of AMG 479

Assess the duration of response

Assess the clinical benefit rate

Assess the progression free survival and overall survival

Full Information

NCT ID

NCT00563680

First Posted

November 21, 2007

Last Updated

October 26, 2016

Sponsor

NantCell, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00563680

Brief Title

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

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NantCell, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exploratory Cohort

Arm Type

Experimental

Arm Description

Arm Title

Main Cohort

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

AMG 479

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

From screening to disease progression

Secondary Outcome Measure Information:

Title

Assess the safety and tolerability of AMG 479

Time Frame

From informed consent to the End of Study/Safety Follow-Up Visit

Title

Assess the duration of response

Time Frame

From screening to disease progression

Title

Assess the clinical benefit rate

Time Frame

From screening to disease progression

Title

Assess the progression free survival and overall survival

Time Frame

From screening to disease progression

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

22508822

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.

Results Reference

background

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Learn more about this trial

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

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