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

October 26, 2016 updated by: NantCell, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (Partial Response [PR] or Complete Response [CR]) as determined by RECIST
Time Frame: From screening to disease progression
From screening to disease progression

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess the safety and tolerability of AMG 479
Time Frame: From informed consent to the End of Study/Safety Follow-Up Visit
From informed consent to the End of Study/Safety Follow-Up Visit
Assess the duration of response
Time Frame: From screening to disease progression
From screening to disease progression
Assess the clinical benefit rate
Time Frame: From screening to disease progression
From screening to disease progression
Assess the progression free survival and overall survival
Time Frame: From screening to disease progression
From screening to disease progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NantCell, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

November 21, 2007

First Submitted That Met QC Criteria

November 21, 2007

First Posted (Estimate)

November 26, 2007

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20060283
  • QUILT-3.025 (Other Identifier: NantCell, Inc.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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