Askin's TumorsPhase 2NCT00563680
QUILT-3.025: A Phase 2 Study of AMG 479 in Relapsed or Refractory Ewing's Family Tumor and Desmoplastic Small Round Cell Tumors
A Phase 2 study testing AMG 479 in people with Askin's Tumors and Desmoplastic Small Round Cell Tumors, run by NantCell, Inc..
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Askin's Tumors, Desmoplastic Small Round Cell Tumors, Estraosseous Ewing's Tumor
- What is being tested?
- AMG 479
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Aug 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- Disease Related
- Known brain metastasis.
- History of bleeding diathesis.
- History of another malignancy.
- History of chronic hepatitis.
- Documented prior history of human immunodeficiency virus.
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- 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.
About this study
Official title: 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.
- Conditions
- Askin's Tumors, Desmoplastic Small Round Cell Tumors, Estraosseous Ewing's Tumor, Ewing's Family Tumor, Ewing's Sarcoma, Primitive Neuroectodermal Tumors (PNETs)
- Being tested
- AMG 479
- Keywords
- AMG 479, IGF-1R, Insulin-like growth factor, Insulin-like growth factor receptor, Ewing's, Sarcoma
- Medical subject headings
- Askin Tumor, Sarcoma, Ewing, Neuroectodermal Tumors, Primitive, Sarcoma, Insulin-Like Growth Factor I, Resistance To
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 479Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: AMG 479 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (Partial Response [PR] or Complete Response [CR]) as determined by RECIST
Measured: From screening to disease progression
Secondary outcomes (4)
Assess the safety and tolerability of AMG 479
Measured: From informed consent to the End of Study/Safety Follow-Up Visit
Assess the duration of response
Measured: From screening to disease progression
Assess the clinical benefit rate
Measured: From screening to disease progression
Assess the progression free survival and overall survival
Measured: From screening to disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionAug 2009
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Askin's TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- NantCell, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563680
- Sponsor's protocol ID
- 20060283
- Other IDs
- QUILT-3.025
- Status last verified
- Oct 2016
- First submitted
- 21 Nov 2007
- Last updated
- 27 Oct 2016
- Results posted
- No
Publications
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.
PubMed 22508822
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of AMG 479 in Relapsed or Refractory Ewing's Family Tumor and Desmoplastic Small Round Cell Tumors
- ClinicalTrials.gov ID
- NCT00563680
- Acronym / sponsor ID
- 20060283
- Conditions
- Askin's Tumors, Desmoplastic Small Round Cell Tumors, Estraosseous Ewing's Tumor, Ewing's Family Tumor, Ewing's Sarcoma, Primitive Neuroectodermal Tumors (PNETs)
- Keywords
- AMG 479, IGF-1R, Insulin-like growth factor, Insulin-like growth factor receptor, Ewing's, Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- NantCell, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 26 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exploratory Cohort | Experimental | Drug: AMG 479If 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. |
| Main Cohort | Experimental | Drug: AMG 479Subjects 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (22 listed)
- Disease Related
- Known brain metastasis.
- History of bleeding diathesis.
- History of another malignancy.
- History of chronic hepatitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 479AMG 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. | Drug | Exploratory Cohort, Main Cohort |
Primary outcome
Objective response rate (Partial Response [PR] or Complete Response [CR]) as determined by RECIST
Time frame: From screening to disease progression
4 secondary outcomes
Assess the safety and tolerability of AMG 479
Time frame: From informed consent to the End of Study/Safety Follow-Up Visit
Assess the duration of response
Time frame: From screening to disease progression
Assess the clinical benefit rate
Time frame: From screening to disease progression
Assess the progression free survival and overall survival
Time frame: From screening to disease progression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Background: PubMed 22508822Tap 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.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMG 479 in people with Askin's Tumors and Desmoplastic Small Round Cell Tumors, run by NantCell, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (Partial Response [PR] or Complete Response [CR]) as determined by RECIST (time frame: From screening to disease progression). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00563680, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.